Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters

Hardik; Apala Sengupta; Chinky

doi:10.21760/jaims.9.11.10

E-ISSN:2456-3110

Research Article

Amajirna

Journal of Ayurveda and Integrated Medical Sciences

2024 Volume 9 Number 11 NOVEMBER

Publisher

www.maharshicharaka.in

Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters

Hardik^1*, Sengupta A², Chinky³

DOI:10.21760/jaims.9.11.10

^1* Hardik, Post Graduate Scholar, Department of Rog Nidan Evum Vikriti Vigyan, Institute of Post Graduate Ayurvedic Education and Research at Shyamadas Vaidya Shastra Pith Hospital, Kolkata, West Bengal, India.

² Apala Sengupta, Professor and HOD, Department of Rog Nidan Evum Vikriti Vigyan, Institute of Post Graduate Ayurvedic Education and Research at Shyamadas Vaidya Shastra Pith Hospital, Kolkata, West Bengal, India.

³ Chinky, Post Graduate Scholar, Department of Panchakarma, Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi, India.

Background: In classical text it had been highlighted that Amajirna is root cause to produce Prameha. Musta is drug which combat Amajirna and it also effective to cure Prameha. So, this gives reasons for need of the present study and also reason for selection of topic.

Aim: To evaluate the pathogenesis of Prameha from Amajirna and the efficacy of Musta (Cyperous rotundus) in both Amajirna and Prameha.

Material and Methods: This study is an open label, randomized, interventional, comparative, prospective, controlled clinical trial. In the present study the patient of Prameha were enrolled following the subjective criteria of Prameha. A total of 60 patients of Prameha were selected from the OPD and IPD of Shyamadas Vaidya Shastra Pith Hospital, Kolkata, West Bengal, and randomly allocated with a computerized randomization method into two groups. Those selected patients were subjected for a confirmatory biochemical analysis of FBS and PPBS. The prediabetic person was interrogated for Amajirna as a past history or present illness, by the subjective criteria of Amajirna. In group A (n= 30), Musta Churna was given for 90 days and in group B (n= 30), Pippali Churna was given for 90 days. Before treatment and after treatment data FBS, PPBS, HBA1C, SGOT, SGPT, serum amylase, serum lipase and alkaline phosphatase enzyme levels were recorded for statistical analysis. This record of assessment was taken at 0, 30, 60 and 90 days. Wilcoxon signed rank test; unpaired t-test were applied.

Result: Both groups showed statistically significant (p<0.05) improvement in chief complaints of Prameha, Amajirna, FBS, PPBS, HBA1C, SGOT, SGPT, serum amylase, serum lipase and alkaline phosphatase.

Conclusion: On percentage wise comparison, better relief was found in Group-A i.e., Musta Churna was found to be more effective in all the subjective and objective parameters than Group-B (Pippali Churna).

Keywords: Prameha, Amajirna, Musta, Pippali

Corresponding Author	How to Cite this Article	To Browse
Hardik, Post Graduate Scholar, Department of Rog Nidan Evum Vikriti Vigyan, Institute of Post Graduate Ayurvedic Education and Research at Shyamadas Vaidya Shastra Pith Hospital, Kolkata, West Bengal, India. Email:	Hardik, Sengupta A, Chinky, Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters. J Ayu Int Med Sci. 2024;9(11):64-76. Available From https://jaims.in/jaims/article/view/4000

Manuscript Received	Review Round 1	Review Round 2	Review Round 3	Accepted
2024-10-09	2024-10-17	2024-10-26	2024-11-07	2024-11-17
Conflict of Interest	Funding	Ethical Approval	Plagiarism X-checker	Note
None	Nil	Yes	14.64

© 2024by H, Sengupta A, Chinkyand Published by Maharshi Charaka Ayurveda Organization. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License https://creativecommons.org/licenses/by/4.0/ unported [CC BY 4.0].

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Download PDF Back To Article Introduction Aim Objectives Materials and Methods Observation and Results Discussion Conclusion References

Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters

Introduction

Prameha^[1] is a disease existing from prehistoric era that is correlated with type 2 Diabetes mellitus, is affecting the 9.3% person of the world and 14% of India.^[2]As of 2014, an estimated 387 million people have diabetes worldwide, with type-2 diabetes making up about 90% of the cases. In classical text it had been highlighted that Amajirna^[3] is the root cause to produce Prameha. In Amajirna^[4] the incomplete or defective digestion caused due to influenced of vitiated Kapha within the stomach.^[5] As a result, Ama^[6] is formed which vitiated consistency of Kapha and vitiate Meda.^[7] The sequence of Meda Dushti ultimately originates Prameha. Acharya Sushruta has considered the Aparipakva (raw/not fully formed) Kapha as cause of Prameha while describing its pathogenesis.^[8] Acharya Dalhana has given the meaning of Aparipakva as Ama which proves that Prameha is caused by Amajirana.^[9] Acharya Charaka has also mentioned Prameha is caused by Amajirana which inturn caused by Kapha aggravating factors in the body.^[10] Agnimandya is caused due to the excess consumption of diet and lifestyle which aggravates Kapha which leads to Ama production in the body which is also called Dushit (impure) Kapha.^[11,12] Till the time, Dushit Kapha remains in the abdominal area (Koshtha), is called Amajirna.

Musta (Cyperous rotundus) is drug which combat Amajirna and it is also effective to cure Prameha. Hence a study was proposed here to verify the hypothesis on genesis of Prameha from Amajirna^[13] and also evaluate to efficacy of Musta (Cyperous rotundus) in both the disease. For this purpose, patients were selected from institute of post graduate ayurvedic education and research in a randomized form. Efficacy of Musta was evaluated through statistical analysis.

Aim

To evaluate the pathogenesis of Prameha from Amajirna and the efficacy of Musta (Cyperous rotundus) in both Amajirna and Prameha.

Objectives

1. To study the diagnostic approach of
2. To explain the pathogenesis of Prameha from

3. To evaluate the efficacy of Musta (Cyperous rotundus) in both Amajirna and Prameha.

Materials and Methods

In the present study the patient of Prameha will be selected following the subjective criteria of Prameha. Those selected patients will be subjected for a confirmatory biochemical analysis of FBS and PPBS. The prediabetic state will be considered here, so the FBS and PPBS and HbA1c will range with in (100-125) mg/dl, (140-199) mg/dl, and (5.7-6.4)% respectively. The prediabetic person will be interrogated for Amajirna as a past history or present illness, by the subjective criteria of Amajirna. The objective criteria of Agnimandya i.e, hypo functioning. Agni will be verified through alkaline phosphatase etc. The selection of patients should do following the inclusion and exclusion criteria. The selected patient will be divided into two groups, Group A and Group B. Group A was treated with Musta (Cyperous rotundus) and Group B was treated with Pippali (piper longum). Group B was treated as control. The both groups were administered by the powder drug. The drug was administered in both the groups in divided doses per day. Before treatment and after treatment data of blood sugar level and enzyme level were recorded for statistical analysis. A complete history sheet was furnished as case report file (CRF).

Study type

Interventional, prospective, randomized, single blind, controlled clinical trial.

Method of sampling

Computer Generated Simple Randomized Method were followed.

Sample size

60 patients were taken for study (30 in each group).

Study settings

The study was conducted in OPD and IPD of the institute I.P.G.A.E & R at S.V.S.P hospital. The patients of Prameha were selected from the OPD through verification of subjective criteria. The selected patients were subjected for verification of subjective criteria. The selected patients were subjected for verification of objective criteria of biochemical investigation.

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During selection of the patient inclusion and exclusion criteria were strictly followed. All details of the patients were recorded and maintained in the specially prepared proforma. Before registering patients informed consent was taken.

Group Design

Group A - Musta Churna

Group B - Pippali Churna (were treated as control)

Before treatment and after treatment data of blood sugar level and enzyme level were recorded for statistical analysis. A complete history sheet will be furnished as case report file (CRF).

Posology

Details of dosage of Musta Churna and Pippali Churna

Table 1: Plan of treatment protocol in Group A

SN	Name of Drug	Dosage Form	Dose & Frequency	Time of administration & Anupana	Duration
1.	Musta Churna	Churna (Powder)	3 gm twice a day	Antebhakta (after food) with luke warm water orally	3 months
Total Duration of Therapy					3 months

Table 2: Plan of treatment Protocol in Group B

SN	Name of Drug	Dosage Form	Dose & Frequency	Time of administration & Anupana	Duration
1.	Pippali Churna	Churna (Powder)	3 gm twice a day	Antebhakta (After food) with luke warm water orally	3 months
Total Duration of Therapy					3 months

Place of study

Department of Roga Nidana Evum Vikriti Vigyana of Institute of Post Graduate Ayurvedic education and Research at Shyamadas Vaidya Sasthra Pith Hospital. 294/3/1, A.P.C. Rd, Kolkatta 09

Study population

A small sample were taken from population those who are suffering from Prameha also presenting Amajirna, visiting the OPD and IPD, of I.P.G.A.E. & R at S.V.S.P Hospital.

Sample size and design

Sampling was done with a method of simple random sampling. The study was conducted with a target of at least 30-40 completed cases in each group. Since the trial medication will be given to only one half of the sample and the other will be treated as control group assuming maximum 30% drop out rate.

This trans state will give a figure of approximately 80 subjects to recruit after screening to achieve the target sample size of not less than 0 in each group.

Inclusion criteria

Adult subjects of either sex between 40-80 years of age.
Presence of cardinal signs and symptoms of Prameha and
Patients showing pre- diabetic stage, with an elevated blood glucose level ranging between FBS≥ {100-125} mg/dl and PPBS≥ {140-199} mg/dl and HBA1C ≥ {5.7-6.4}.
Biochemical assessment showing altered level of serum amylase, Serum lipase, aminotransferase (SGOT & SGPT), alkaline phosphatase to interpret on status of Agni.
Patient those are not taking any type of medicine except research drug.

Exclusion criteria

Diabetic stage.
Pre-diabetic state with any complication.
Dyspepsia due to any type of malignant condition.
Dyspepsia where any type of surgical interference is necessary
Pre-diabetic woman with pregnancy.

Study variables

Respective relevant objective parameters of the disease are variables.

Data collection and interpretation

The drug was administered for 90 consecutive days for each patient for both the groups and were assessed after 90 days after the date of registration. The case report form was filled up in both the groups & the baseline parameter should be recorded. In both the groups, the following laboratory investigations were conducted during baseline & final follow up.

Schedule of data collection:

In each group, the subject will be required at least 4 visits during studies.

Visit 1 - Screening & enrolment

Visit 2 - First follow up (Day 30)

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Visit 3 - Second follow up (Day 60)

Visit 4 - Final follow up (Day 90)

Laboratory investigations

FBS
PPBS
HBA1C
Serum amylase
Serum lipase
SGOT
SGPT
Alkaline phosphatase

All above mentioned investigation were performed before commencement of the treatment and after completion of the treatment.

Clinical parameters

Screening criteria for Prameha^[14]

Swedanga - excessive sweating
Anga Gandha - bad body odour
Shithila Anga - Flabbiness of body
Sahyya Ashana Prasukhe - sedentary lifestyle
Ratischa - Ease of life
Hrt Upadeha - heaviness in cardiac region
Netra Jiva Shravana Upadeha - watering of eye tongue and ear
Ghanangta - Obesity
Kesha Nakha Ativriddhi - excessive growth of hair and Feet
Shita Priyata - preference to cold
Gala Talu Sosha - dryness of throat and palate
Madhuryam Ashya - sweetness of mouth
Kara Pada Daha - burning sensation of hand and feet
Mutre Abhidhawanti Pippilika - swarming of ants in urine

Screening criteria for Amajirna^[15]

Shotho Gandakshi Kutaga - swelling over eyes and cheeks
Yatha Bhuktam Avidagdham Udgara - belching similar to those occurring soon after meal

Utkleda - sensation of vomiting
Mala Vata Apravritti
Gourvam - heaviness in body/ abdomen

Table 3: Screening criteria for Amajirna

SN	Clinical Features	Finding	Score
1	Shotho Gandakshi Kutaga	None	0
		Mild	1
		Moderate	2
		Severe	3
2	Yatha Bhuktam Avidagdham Udgara	None	0
		Mild	1
		Moderate	2
		Severe	3
3	Utkleda	None	0
		Mild	1
		Moderate	2
		Severe	3
4	Mala Vata Apravritti	None	0
		Mild	1
		Moderate	2
		Severe	3
5	Gourvam	None	0
		Mild	1
		Moderate	2
		Severe	3

Observation and Results

Table 4: Agni wise distribution of patients

SN	Agni	Total number of patients (n)	Percentage (%)
1.	Manda	31	51.67
2.	Vishama	18	30.00
3.	Tikshana	07	11.67
4.	Sama	4	6.66
Total		60	100

It shows that 51.67% of patients had Mandagni, 34% of patients had Vishamagni, 11.67% patients had Tikshana Agni & 6.66% patient had Sama Agni.

Figure 1: Showing Agni wise distribution of patients

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Table 5: Chief complaints wise distribution of Amajirna patients

SN	Chief complaints	Total number of patients (n)	Percentage (%)
1.	Shotho Gandakshi Kutaga	37	61.67
2.	YathaBhuktam Avidagdham Udgara	50	83.33
3.	Utkleda	38	63.33
4.	Mala Vata Apravritti	37	61.67
5.	Gourvam	18	30.00

It shows that 83.33% of the patient had complaints of Yatha Bhuktam Avidagdham Udgara, followed by Utkleda in 63.33%, Shotho Gandakshi Kutaga and Mala Vata Apravritti in 61.67% and Gourvama in 30% of patients.

Figure 2: Showing chief complaints wise distribution of Amajirna patients

Table 6: FBS wise distribution of patients

SN	FBS (mmol/L)	Total number of patients (n)	Percentage (%)
1	≥100	48	80
2	101- 125	12	20
Total		60	100

It shows that FBS level was found up to ≥100 mmol/L in 80% followed by 101- 125 mmol/L in 20% of the patients.

Figure 3: Showing FBS wise distribution

Table 7: PPBS wise distribution of patients

SN	PPBS (mmol/L)	Total number of patients (n)	Percentage (%)
1	≥140	54	90.00
2	141- 150	4	6.67
3	151-199	2	3.33
Total		60	100

It shows that PPBS level was found up to ≥140 mmol/L in 90% followed by 141-150 mmol/L in 6.67% and 151-199 mmol/L in 3.33% of the patients.

Figure 4: Showing PPBS wise distribution of patients

Table 8: HbA1c wise distribution of patients

SN	HbA1c (%)	Total number of patients (n)	Percentage (%)
1	≥5.7	46	76.67
2	5.7- 6.0	13	21.66
3	6.1-6.4	1	01.67
Total		60	100

It shows that HbA1c level was found up to ≥5.7% in 76.67% followed by 5.7- 6.0% in 21.66% and 6.1-6.4% in 01.67% of the patients.

Figure 5: Showing HbA1c wise distribution

Table 9: Showing serum amylase wise distribution of patients

SN	Serum amylase (IU/L)	Total number of patients (n)	Percentage (%)
1	≥100	36	60.00
2	101 - 200	23	38.33
3	>200	1	01.67
Total		60	100

It shows that serum amylase level was found up to ≥100 IU/L in 60% followed by 101 – 200 in 38.33% and >200 in 1.67% of the patients.

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Figure 6: Showing serum amylase wise distribution

Table 10: Showing serum lipase wise distribution of patients

SN	Serum Lipase (IU/L)	Total number of patients (n)	Percentage (%)
1	≥200	48	80.00
2	201 - 300	11	18.33
3	>300	1	01.67
Total		60	100

It shows that serum lipase level was found up to ≥200 IU/L in 80% followed by 201 – 300 in 18.33% and >300 in 1.67% of the patients.

Figure 7: Showing that Serum lipase wise distribution

Table 11: Showing SGOT wise distribution of patients

SN	SGOT (units/liter of serum)	Total number of patients (n)	Percentage (%)
1	≥50	48	80.00
2	51 - 150	12	20.00
3	>150	00	00
Total		60	100

It shows that SGOT level was found up to >150 units/litre of serum in 80% followed by 51 – 150 units/litre of serum in 20% and ≥50 units/litre of serum in 0% of the patients.

Figure 8: Showing that SGOT wise distribution

Table 12: Showing SGPT wise distribution of patients

SN	SGPT (units / litre of serum)	Total number of patients (n)	Percentage (%)
1	≥60	40	66.67
2	61 - 150	20	33.33
3	>150	00	00
Total		60	100

It shows that SGPT level was found up to >150 units/litre of serum in 66.67% followed by 61 – 150 units/litre of serum in 33.33% and ≥60 units/litre of serum in 00% of the patients.

Figure 9: Showing SGPT wise distribution

Table 13: Showing alkaline phosphatase wise distribution of patients

SN	ALP (U/L)	Total number of patients (n)	Percentage (%)
1	≥120	39	65.00
2	121 - 200	21	35.00
3	>200	00	00.00
Total		60	100

It shows that ALP level was found up to >200 (U/L) in 65% followed by 121 – 200 (U/L) in 35% and ≥120 (U/L) in 00% of the patients.

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Figure 10: Showing alkaline phosphatase wise distribution

Effect of therapy on Objective criteria FBS

Table 14: Effect of therapy on FBS

Group	Mean Value		Diff.	% Relief	Paired “t” test
Group	BT	AT	Diff.	% Relief	S.D.	S.E	“t”	p	Signi.
A	161.76	143.11	18.65	11.52	35.90	7.04	2.64	<0.001	HS
B	166.86	146.55	20.30	12.16	38.95	7.23	2.80	<0.05	S

It shows that, Group-A and Group-B showed 11.52% and 12.16% reduction in FBS respectively, which was statistically highly significant and significant respectively.

Table 15: Comparison of effect of therapy on FBS

Group	Difference in means	Unpaired “t” test
Group	Difference in means	S.D.	S.E.	“t”	p	Significant
A	18.65	35.90	7.04	1.1	<0.05	S
B	20.31	38.95	7.23	1.1	<0.05	S

It shows that, on applying Un-paired “t” test, the difference of decrease in FBS levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on FBS levels.

PPBS

Table 16: Effect of therapy on PPBS

Group	Mean Value		Diff.	% Relief	Paired “t” test
Group	BT	AT	Diff.	% Relief	S.D	S.E.	“t”	p	Signi.
A	211.26	184.5	26.76	18.55	39.90	7.82	3.70	<0.001	HS
B	228.75	186.3	42.44	12.66	61.75	11.46	3.42	<0.05	S

It shows that Group-A and Group-B showed 18.55% and 12.66% reduction in PPBS respectively, which was statistically highly significant and significant respectively.

It shows that on applying Un-paired “t” test, the difference of decrease in PPBS levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on PPBS levels.

Table 17: Comparison of effect of therapy on PPBS

Group	Difference in means	Unpaired “t” test
Group	Difference in means	S.D.	S.E.	“t”	p	Significant
A	26.76	39.9	7.82	2.6	<0.05	S
B	42.44	61.75	11.46	2.6	<0.05	S

HbA1c

Table 18: Effect of therapy on HbA1c

Group	Mean Value		Diff.	% Relief	Paired “t” test
Group	BT	AT	Diff.	% Relief	S.D.	S.E.	“t”	p	Signi.
A	7.8	7.6	0.20	20.34	0.81	0.16	4.44	<0.001	HS
B	8.4	7.4	0.97	11.47	1.34	0.25	3.91	<0.05	S

It shows that Group-A and Group-B showed 20.34% and 11.47% reduction in HbA1c respectively, which was statistically highly significant and significant respectively.

Table 19: Comparison of effect of therapy on HbA1c

Group	Difference in means	Unpaired “t” test
Group	Difference in means	S.D.	S.E.	“t”	p	Significant
A	0.22	0.80	0.15	2.4	<0.05	S
B	0.97	1.34	0.25	2.4	<0.05	S

It shows that on applying Un-paired “t” test, the difference of decrease in HbA1c levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on HbA1c levels.

Serum amylase

Table 20: Effect of therapy on Serum amylase

Group	Mean Value		Diff.	% Relief	Paired “t” test
Group	BT	AT	Diff.	% Relief	S.D.	S.E.	“t”	p	Signi.
A	25.99	25.30	0.69	18.30	5.98	1.17	4.35	<0.001	HS
B	27.03	24.82	2.20	14.35	2.74	3.85	1.24	<0.05	S

It shows that Group-A and Group-B showed 18.30% and 14.35% reduction in serum amylase respectively, which was statistically highly significant and significant respectively.

Table 21: Comparison of effect of therapy on Serum amylase

Group	Difference in means	Unpaired “t” test
Group	Difference in means	S.D.	S.E.	“t”	p	Significant
A	0.69	5.98	1.17	1.23	<0.05	S
B	0.41	2.74	1.52	1.23	<0.05	S

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It shows that on applying Un-paired “t” test, the difference of decrease in serum amylase levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on serum amylase levels.

Serum lipase

Table 22: Effect of therapy on Serum lipase

Group	Mean Value		Diff.	% Relief	Paired “t” test
Group	BT	AT	Diff.	% Relief	S.D.	S.E.	“t”	p	Signi.
A	7.71	6.98	0.19	12.72	0.47	0.09	2.08	<0.001	HS
B	7.09	7.02	0.06	10.98	0.41	0.07	1.34	<0.05	S

It shows that Group-A and Group-B showed 12.72% and 10.98% reduction in serum lipase respectively, which was statistically highly significant and significant respectively.

Table 23: Comparison of effect of therapy on Serum lipase

Group	Difference in means	Unpaired “t” test
Group	Difference in means	S.D.	S.E.	“t”	p	Significant
A	0.19	0.47	0.09	1.04	<0.05	S
B	0.16	0.41	0.07	1.04	<0.05	S

It shows that on applying Un-paired “t” test, the difference of decrease in serum lipase levels in both groups was statistically highly significant. This indicates that both the drugs provided similar effect on serum lipase levels.

SGOT

Table 24: Effect of therapy on SGOT

Group	Mean Value		Diff.	% Relief	Paired “t” test
Group	BT	AT	Diff.	% Relief	S.D.	S.E	“t”	p	Signi.
A	41.38	33.13	8.23	19.8	41.09	8.05	4.45	<0.001	HS
B	27.03	24.82	2.20	8.13	20.74	3.85	2.02	<0.05	S

It shows that Group-A and Group-B showed 8.23% and 2.20% reduction in SGOT respectively, which was statistically high significant % sig. respectively.

Table 25: Comparison of effect of therapy on SGOT

Group	Difference in means	Unpaired “t” test
Group	Difference in means	S.D.	S.E.	“t”	p	Significant
A	8.23	41.09	8.05	2.45	<0.05	S
B	2.13	20.72	3.84	2.45	<0.05	S

It shows that on applying Un-paired “t” test, the difference of decrease in SGOT levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on SGOT levels.

SGPT

Table 26: Effect of therapy on SGPT

Group	Mean Value		Diff.	% Relief	Paired “t” test
Group	BT	AT	Diff.	% Relief	S.D	S.E	“t”	p	Signi.
A	3.16	2.5	0.33	24.86	1.15	0.66	2.39	<0.001	HS
B	1.44	0.65	0.79	10.44	1.78	0.33	1.34	<0.05	S

It shows that Group-A & Group-B showed 24.86% & 10.44% reduction in SGPT respectively, which was statistically highly significant & sig. respectively.

Table 27: Comparison of effect of therapy on SGPT

Group	Difference in means	Unpaired “t” test
Group	Difference in means	S.D.	S.E.	“t”	p	Significant
A	0.19	1.66	0.32	1.28	<0.05	S
B	0.79	1.78	0.34	1.28	<0.05	S

It shows that on applying Un-paired “t” test, the difference of decrease in SGPT levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on SGPT levels.

Alkaline Phosphatase

Table 28: Effect of therapy on Alkaline Phosphatase

Group	Mean Value		Diff.	% Relief	Paired “t” test
Group	BT	AT	Diff.	% Relief	S.D	S.E	“t”	p	Signi.
A	7.8	7.6	0.20	20.34	0.81	0.16	4.44	<0.001	HS
B	8.4	7.4	0.97	11.47	1.34	0.25	3.91	<0.05	S

It shows that Group-A and Group-B showed 20.34% and 11.47% reduction in alkaline phosphatase respectively, which was statistically highly significant and significant respectively.

Table 29: Comparison of effect of therapy on Alkaline Phosphatase

Group	Difference in means	Unpaired “t” test
Group	Difference in means	S.D.	S.E.	“t”	p	Significant
A	0.22	0.80	0.15	2.4	<0.05	S
B	0.97	1.34	0.25	2.4	<0.05	S

It shows that on applying Un-paired “t” test, the difference of decrease in alkaline phosphatase levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on alkaline phosphatase levels.

Discussion

The subjective & objective parameter were assessed with data compilation & statistical analysis.

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The obtained data of before & after treatment of experimental group were evaluated through 't' test. The before treatment and after treatment value of blood glucose level and gastrointestinal enzymes level were computed to achieve 't' test and 'p' value by paired 't' test. The comparative study between Group A and Group B were done through unpaired 't' test.

The obtained data of before treatment & after treatment were computed & analyzed statistically. The values are expressed as Mean ± SEM (Standard Error of Mean). The data were analyzed by paired ‘t’ test. A level of p<0.001 was considered as statistically highly significant and p<0.05 was considered as statistically significant.

Comparative study of both Group - A & Group - B was done, through analysis of the obtained data by unpaired ‘t’ test. Level of significance was noted & interpreted accordingly.

Chief complaints of Amajirna

It was observed that, 83.33% of the patient had complaints of Yatha Bhuktam Avidagdham Udgara, followed by Utkleda in 63.33%, Shotho Gandakshi Kutaga and Mala Vata Apravritti in 61.67% and Gourvam in 30% of patients. The above data supports the hypothesis that Amajirna is Kapha dominance Ajirna and if we recognize Amajirna from other type of Ajirna we can treat the disease according (Table 2).

Blood sugar levels

FBS level was found up to ≥100 mmol/L in 80% followed by 101- 125 mmol/L in 20% of the patients. PPBS level was found up to ≥140 mmol/L in 90% followed by141-150 mmol/L in 6.67% and 151-199 mmol/L in 3.33% of the patients. HbA1c level was found up to ≥5.7% in 76.67% followed by 5.7- 6.0% in 21.66% and 6.1-6.4% in 1.67% of the patients (Table 3,4,5).

Serum amylase level was found up to ≥100 IU/L in 60% followed by 101 – 200 in 38.33% and >200 in 6.67% of the patients. Serum lipase level was found up to ≥200 IU/L in 80% followed by 201 – 300 in 18.33% and>300 in 1.67% of the patients. SGOT level was found up to >150 units/litre of serum in 80% followed by 51 – 150 units/litre of serum in 20% and ≥50 units/litre of serum in 0.00% of the patients.

SGPT level was found up to ≥60 units/litre of serum in 66.67% followed by 61 – 150 units/litre of serum in 33.33% and >150 units/litre of serum in 0.00% of the patients. ALP level was found up to >200 (U/L) in 65% followed by 121 – 200 (U/L) in 35% and ≥120 (U/L) in 0.00% of the patients (Table 6,7,8,9,10).

Fasting Blood Sugar level

Group-A and Group-B showed 11.52% and 12.16% reduction in FBS respectively, which was statistically highly significant and significant respectively. In diabetic state, there is beta cell failure leading to reduced basal insulin secretion in fasting state, drug showed fasting blood sugar lowering effect which is statistically significant in both the groups. It shows possibility of beta cell protective or regenerative effect of drugs (Table 11).

Post Prandial Blood Sugar level

Group-A and Group-B showed 18.55% and 12.66% reduction in PPBS respectively, which was statistically highly significant and significant respectively, this may be because of retarding the carbohydrate absorption from intestine, α- glucosidase inhibitor action & improvement in peripheral glucose uptake (Table 13).

Serum HbA1c

Group-A and Group-B showed 20.34% and 11.47% reduction in HbA1c respectively, which was statistically highly significant and significant respectively (Table 15).

On applying Un-paired “t” test, the difference of decrease in HbA1c levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on HbA1c levels (Table 16).

Serum amylase

Group-A and Group-B showed 18.30% and 14.35% reduction in serum amylase respectively, which was statistically highly significant and significant respectively (Table 17).

On applying Un-paired “t” test, the difference of decrease in serum amylase levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on serum amylase levels (Table 18).

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Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters

Serum lipase

Group-A and Group-B showed 12.72% and 10.98% reduction in serum lipase respectively, which was statistically highly significant and significant respectively (Table 19).

On applying Un-paired “t” test, the difference of decrease in serum lipase levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on serum lipase levels (Table 20).

SGOT

Group-A and Group-B showed 8.23% and 2.20% reduction in SGOT respectively, which was statistically highly significant and significant respectively (Table 21).

On applying Un-paired “t” test, the difference of decrease in SGOT levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on SGOT levels (Table 22).

SGPT

Group-A and Group-B showed 24.86% and 10.44% reduction in SGPT respectively, which was statistically highly significant and significant respectively (Table 23).

On applying Un-paired “t” test, the difference of decrease in SGPT levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on SGPT levels (Table 24)

Alkaline phosphatase

Group-A and Group-B showed 20.34% and 11.47% reduction in alkaline phosphatase respectively, which was statistically highly significant and significant respectively (Table 25).

This can be inferred that existing duration of therapy have significant role on FBS, PPBS, HbA1c, serum amylase, serum lipase, SGOT, SGPT, Alkaline phosphatase level.

Comparative Effect of Therapy

Effect on Chief complaints

In Group A, Shotho Gandakshi Kutaga was relieved by 76.50% which was statistically highly significant (p<0.001),

while in Group B it was relieved by 58.82% which was statistically significant (p<0.05) In Group A, Yatha Bhuktam Avidagdham Udgara was relieved by 88.02% which was statistically highly significant (p<0.001), while in Group B it was relieved by 41.17% which was statistically significant (p<0.05) In Group A, Utkleda was relieved by 80.64% which was statistically highly significant (p<0.001), while in Group B it was relieved by 32.50% which was statistically significant (p<0.05).

In Group A, Mala Vata Apravritti was relieved by 80% which was statistically highly significant (p<0.001), while in Group B it was relieved by 33.33% which was statistically significant (p<0.05). In Group A, Gouravam was relieved by 78.37% which was statistically highly significant (p<0.001), while in Group B it was relieved by 55.10% which was statistically significant (p<0.05) (Table 6.29).

The above data supports the hypothesis that Amajirna Prameha is Kapha dominance Ajirna and if we recognize Amajirna from other type of Ajirna we can treat the disease according. Musta churna show good result because Katu, Tikta and Kashya Rasa, Laghu and Ruksha Guna, Sheeta Virya and Katu Vipaka gives Kaphapitta Shamana effect and as it is having Katu Rasa, Laghu Guna, it increases the Agni and also give Kapha Shamana, Deepana, Pachana, Rochana, Ama hara and Lekhana properties. Hence the relief observed was higher and statistically highly significant. On the other hand, Pippali Churna due to its Katu Rasa, Laghu Snigdha and Tikshna Guna, Anusha sheeta Virya, Madhura Vipaka and Vatakaphashamaka Doshaghnata. Due to these qualities, it helps in relieving Amajirna Prameha. Hence the relief observed was statistically significant. Statistically all Amajirna Prameha Lakshana show highly significant result due to the Agni Deepana, Ama Pachana Premehahara action of, Ama was disappeared and hence the symptoms of Amajirna Prameha got relieved.

Overall effect of therapy

In Group A, marked improvement was observed in 83.33% of the patient, moderate improvement was observed in 16.67% of patients. In Group B, marked improvement was observed in 60% patients, moderate improvement was observed in 33.33% patients and mild improvement was observed in 6.67% patients. No patients were observed as complete cured and unchanged in both the groups.

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Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters

Conclusion

Amajirna Prameha (Pre-Diabetes) with dominancy of Kapha among the Doshas, Meda among the Dooshyas. Both the groups were having statistically significant result in the parameters i.e., FBS, PPBS, HBA1C, SGOT, SGPT, serum amylase, serum lipase and alkaline phosphatase. But in inter group comparison, Musta Churna was found to be more effective than Pippali Churna. There is further scope for new researchers to used formulation containing more drugs instead of single drug. The present work could be conducted with large sample size and more days of drug given which might give better results.

References

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Research Article

Amajirna

Journal of Ayurveda and Integrated Medical Sciences

Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters

Hardik1*, Sengupta A2, Chinky3

Introduction

Aim

Objectives

Materials and Methods

Observation and Results

Discussion

Conclusion

References

Hardik^1*, Sengupta A², Chinky³