E-ISSN:2456-3110

Research Article

Madhumeha

Journal of Ayurveda and Integrated Medical Sciences

2022 Volume 7 Number 8 September
Publisherwww.maharshicharaka.in

An open label, single arm prospective clinical study on the effectiveness of Pugaarimeda Kashaya in Madhumeha (Diabetes Mellitus Type 2)

Pavithra P.1*, Vasantha B.2, Totad M.3
DOI: http://dx.doi.org/10.21760/jaims.7.8.1

1* P Pavithra, Post Graduate Scholar, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.

2 B Vasantha, Associate Professor, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.

3 Muttappa Totad, Associate Professor & HOD, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.

Background: Diabetes mellitus (DM) is one of the most common non-communicable diseases globally. It is characterized by multiple metabolic disorders that results in hyperglycemia. Diabetes mellitus type-2 (DM2) is the most common type accounting almost 90% of cases of DM. Madhumeha on the basis of similar etiology, signs and symptoms can be co-related with Diabetes mellitus type-2. It is also described by the term Kshoudrameha or Ojomeha. Pugaarimeda Kashaya with Madhu as Anupana is mentioned in Brihat Nighantu Ratnakara in the management of Madhumeha. Objective: To clinically evaluate the effectiveness of Pugaarimeda Kashaya in Madhumeha (Diabetes mellitus type-2). Materials and Methods: Among 31 registered subjects, 28 of them completed the course of treatment. They were administered with Pugaarimeda Kashaya orally 100ml per day (50ml twice daily before food) with Anupana of Madhu 5ml for a period of 30 days. Blood and urine glucose test was done on 1st, 31st day of study initiation. For Statistical analysis subjective parameters were assessed by Cochran’s Q test followed by McNemar test and objective parameters were assessed by Paired sample T Test. Results: There was statistically significant improvement observed in the signs and symptoms of Madhumeha with blood and urine glucose levels. (p<0.05) Conclusion: Pugaarimeda Kashaya was found effective in the management of Madhumeha.

Keywords: Madhumeha; Diabetes Mellitus; Pugaarimeda Kashaya

Corresponding Author How to Cite this Article To Browse
P Pavithra, Post Graduate Scholar, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.
Email: 		P Pavithra, B Vasantha, Muttappa Totad, An open label, single arm prospective clinical study on the effectiveness of Pugaarimeda Kashaya in Madhumeha (Diabetes Mellitus Type 2). J Ayu Int Med Sci. 2022;7(8):1-7.
Available From
https://www.jaims.in/jaims/article/view/1967

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2022-07-27 2022-07-29 2022-08-05 2022-08-12 2022-08-19
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
Nil Nil Yes 16%

© 2022by P Pavithra, B Vasantha, Muttappa Totadand 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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Pavithra P et al: Effectiveness Pugaarimeda Kashaya Madhumeha (Diabetes Mellitus Type 2)

Introduction

Diabetes has been increasing at an alarming rate since the start of the 21st century, driven largely by obesity and sedimentary life styles. The latest 2021 data from IDF Diabetes Atlas 10th edition estimated 537 million adults are living with Diabetes. This is predicted to rise to 643 million by 2030 and 783 million by 2045.[1] India is projected to be home to 109 million individuals with Diabetes mellitus (DM) by 2035.[2] Among them Diabetes mellitus type-2(DM2) is the most common type accounting almost 90% of cases of DM.[3]

Diabetes mellitus type-2 is a chronic disorder which primarily occurs due to abnormal metabolism of glucose, fat and protein.[4] The high incidence is found to have association between age, family history, obesity, urbanization, lower socio-economic status, high calorie food and lack of physical activity. The increase in the prevalence of Diabetes mellitus type-2 across the world has become an important public health problem.[3] DM2 clinically presents with polyuria, polydypsia, polyphagia, paresthesia, loss of weight, weakness of unknown cause and glucosuria.[4] The etiology, signs and symptoms of Diabetes Mellitus are found to be similar with of Madhumeha.

Madhumeha is included under the Vimshati Prameha and is explained as one among the Vataja Prameha.[5] Madhumeha is one of the Ashta Mahagadas.[6] It is also described by the term Kshoudrameha.[7] Madhumeha is classified into two types such as Dhatukshayajanya and Avaranajanya.[6] In Samprapti of Avaranajanya Madhumeha Kapha, Pitta, Meda and Mamsa are excessively increased. The vitiated Kapha and Pitta obstruct the path of Vata causing its provocation. This obstructed Vata transforms Madhurata of Ojas into Kashaya and expels Ojas through Basti causing Madhumeha with Lakshanas being Madhuryata of both Mutra and Sharira.[8]

All other Prameha can be called as Madhumeha and all other Meha would end up in Madhumeha when left untreated.[6,7] Madhumeha is Krichrasadhya or Yapya or Asadhya in nature.

Pugaarimeda Kashaya with Madhu as Anupana is mentioned in management of Madhumeha.[9] It has two ingredients Puga and Arimeda. Puga and Arimeda are having Ruksha Guna, Tikta Kashaya

Rasa, Katu Vipaka, Ushna Virya, Kapha-Pittahara and Medoshoshana properties which is essential in Samprapti Vighatana of Madhumeha.[10,11] Experimental studies on Puga has showed antidiabetic activity by suppressing the action of intestinal glucosidase enzymes, reduction of blood glucose level, improved glycogen content and Arimeda has showed inhibitory activity against α-glucosidase type-4 enzyme.[12,13,14]

This study was intended to validate the effectiveness of Pugaarimeda Kashaya in Madhumeha (Diabetes mellitus type-2).

Objective

To evaluate the effect of Pugaarimeda Kashaya in the management of Madhumeha (Diabetes Mellitus type 2).

Materials and Methods

Source of Data: 31 participants of Madhumeha fulfilling the diagnostic and inclusion criteria were recruited from outpatient department of Sri Dharmashtala Manjunatheshwara College of Ayurveda and Hospital, Hassan.

Methods of collection of data

31 participants were screened at outpatient department and Data were collected using specially prepared case report form (CRF) by incorporating all aspects of Madhumeha and Diabetes mellitus type-2.

Diagnostic Criteria

1. Signs and symptoms of Madhumeha like Prabhoota Mutrata, Pipaasa Adhikya, Kshudha Adhikya, Karapada Daha, Karapada Suptata or Angasaada

2. Fasting blood glucose >126 mg/dl or

3. Postprandial Blood Glucose >200mg/dl or

4. HbA1c >6.5%

Inclusion Criteria

1. Fresh cases and diagnosed cases of Diabetes mellitus type-2 on Ayurvedic treatment

2. Participants of either gender of age between 30-70 years

3. Participants who are ready to sign the informed consent form


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Pavithra P et al: Effectiveness Pugaarimeda Kashaya Madhumeha (Diabetes Mellitus Type 2)

Exclusion Criteria

1. Participants of Diabetes mellitus type-2 on insulin

2. Participants of Diabetes mellitus type-2 with HbA1c >10%

3. Participants with known case of cardiac illness, impaired kidney and liver function

4. Pregnant and lactating women

Laboratory Investigations

  • Fasting blood glucose
  • Post prandial blood glucose
  • Fasting urine sugar
  • Post prandial urine sugar
  • HbA1c

Study design: The study was an open label, single arm, prospective clinical study on 31 participants of Madhumeha using convenience sampling technique.

Intervention

Medicine - Pugaarimeda Kashaya

Source and authentication of raw drug

Arimeda stem bark was purchased and authenticated from CKKM Pharmacy. Kerala (GMP certified pharmacy). Puga fruit was purchased from market and authenticated from the Department of Dravyaguna of Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hassan.

Plan of Treatment

Pugaarimeda Kashaya: 100ml/day in divided dose of 50ml twice daily before food for 30 days.

Anupana: 5ml of Madhu

Follow up: Starting from the first day of treatment, follow up was done on 15th and 31st day (for primary outcome measures) and before treatment and on 31st day for secondary outcome measures

Assessment Criteria

Primary outcome measures

The assessment of effect of treatment was done based on the changes in signs and symptoms of Madhumeha such as:

Prabhoota Mutrata, Pipasa Adhikya, Kshudha Adhikya, Karapada Daha, Karapada Suptata, or Angasaada

Secondary outcome measures

Effect was assessed with changes in;

  • Fasting blood glucose - Before and after treatment.
  • Post prandial blood glucose - Before and after treatment.
  • Fasting urine sugar - Before and after treatment.
  • Post prandial urine sugar - Before and after treatment.

Observation

Table 1: Before treatment symptom wise distribution of 31 subjects of Madhumeha

Symptoms Parameter Total %
Present Absent
Prabhoota Mutrata 19 12 31   61.3
Kshudha Adhikya 4 27 12.9
Pipasa Adhikya 8 23 25.8
Karapada Daha 6 25 19.4
Karapada Suptata 18 13 58.1
Angasaada 22 9 71.0

Results

A total of 31 participants of Madhumeha were registered for the study, 28 participants completed the trial and 3 drop outs.

Table 2: Effect of Pugaarimeda Kashaya in Prabhoota Mutrata

Parameter Value N Cochran’s Q P value Remarks
Present Absent
BT 18 10 28 19.500   <.05 S
15th day 15 13
31st day 6 22

Cochran’s Q test, BT – Before Treatment, S – Highly Significant, N – number of objects

Table 3: Effect of Pugaarimeda Kashaya in Kshudha Adhikya

Parameter Value N Cochran’s Q P value Remarks
Present Absent
BT 4 24 28 .000a >.05 NS
15th day 4 24
31st day 4 24

Cochran’s Q test, BT – Before Treatment, S – Significant, N – number of objects


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Pavithra P et al: Effectiveness Pugaarimeda Kashaya Madhumeha (Diabetes Mellitus Type 2)

Table 4: Effect of Pugaarimeda Kashaya in Pipasa Adhikya


Parameter Value N Cochran’s Q P value Remarks
Present Absent
BT 7 21 28 2.000a >.05 NS
15th day 7 21
31st day 6 22

Cochran’s Q test, BT – Before Treatment, S – Significant, N – number of objects

Table 5: Effect of Pugaarimeda Kashaya in Karapada Daha


Parameter Value N Cochran’s Q P value Remarks
Present Absent
BT 5 23 28 4.000a >.05 NS
15th day 5 23
31st day 3 25

Cochran’s Q test, BT – Before Treatment, S – Significant, N – number of objects

Table 6: Effect of Pugaarimeda Kashaya in Karapada Suptata


Parameter Value N Cochran’s Q P value Remarks
Present Absent
BT 17 11 28 20.42a <.05 S
15th day 13 15
31st day 4 24

Cochran’s Q test, BT – Before Treatment, S – Highly Significant, N – number of objects

Table 7: Effect of Pugaarimeda Kashaya in Angasaada

Parameter Value N Cochran’s Q P value Remarks
Present Absent
BT 19 9 28 26.235a <.05 S
15th day 8 20
31st day 2 26

Cochran’s Q test, BT – Before Treatment, S –Highly Significant, N – number of objects

Table 8: Effect of Treatment on Fasting Blood Glucose in 28 Subjects

Pair Mean N SD P value Remarks
FBS BT 223.39 28 47.62 <.05 S
FBS 31st Day 148.57 28 52.69

Paired T test, BT-before treatment, SD-standard deviation, N-no of subjects

Table 9: Effect of Treatment on Post Prandial Blood Glucose in 28 Subjects

Pair Mean N             SD P value Remarks
PPBS BT 300.86 28 48.21 <.05 S
PPBS 31st Day 216.60 28 63.85

Paired T test, BT-before treatment, SD-standard deviation, N-no of subjects

Table 10: Effect of Treatment on Fasting urine sugar in 28 Subjects

Pair Mean N SD P value Remarks
FUS BT 1.250 28 0.54 <.05 S
FUS 31st Day 0.4107 28 0.55

Paired T test, BT - Before treatment, SD - Standard deviation, N – No. of subjects

Table 11: Effect of Treatment on Post Prandial Urine Sugar in 28 Subjects

Pair Mean N SD P value Remarks
PPUS BT 1.75 28 0.319 <.05 S
PPUS 31st Day 0.86 28 0.715

Paired T test, BT - Before treatment, SD - Standard deviation, N – No. of subjects

Discussion

Effect of Pugaarimeda Kashaya on Prabhoota Mutrata

There was statistically significant improvement in Prabhoota Mutrata after treatment with p value <0.05. Prabhoota Mutrata is Mootra Vaha Sroto Dushti Lakshana caused due to Mandagni, increase in Bahu Drava Shleshma, Abadha Dhatus leading to increased Malas and Kledamsha.

Pugaarimeda Kashaya having Kashaya-Tikta Rasa, Ruksha Guna, Katu Vipaka, Kapha-Kleda Soshaka property reduces the Bahumutrata. The Deepana, Pachana Karma of Puga, Ushna Virya of Arimeda improves Agni, so further formation of Ama, Kleda will be prevented.

Effect of Pugaarimeda Kashaya on Kshudha Adhikya

There was no statistically significant improvement in Kshudha Adhikya after the treatment with p>0.05.

Effect of Pugaarimeda Kashaya on Pipasa Adhikya

There was no statistically significant improvement in Pipasa Adhikya after the treatment with p>.05.


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Pavithra P et al: Effectiveness Pugaarimeda Kashaya Madhumeha (Diabetes Mellitus Type 2)

Effect of Pugaarimeda Kashaya on Karapada Daha

There was no statistically significant improvement in Karapada Daha after the treatment with p>.05.

Effect of Pugaarimeda Kashaya on Karapada Suptata

There was statistically significant improvement in Karapada Suptata after treatment with p value <0.05. Karapada Suptata may be due to Prakopa of Kapha Dosha. Pugaarimeda Kashaya is having Kashaya, Tikta Rasa, Ushna Virya, Katu Vipaka and Kapha-Vatahara property which pacifies Kapha, thus reduces Karapada Suptata.

Effect of Pugaarimeda Kashaya on Angasaada

There was statistically significant improvement in Angasaada after treatment with p value <0.05. Angasaada may be caused due to vitiated Kapha and Abadha Dhatus particulary Meda Dhatu in Madhumeha. Pugaarimeda Kashaya is having Kashaya Rasa, Tikta Rasa, Ushna Virya, Katu Vipaka which does Ama Pachana, Agni Deepana and possesses Kapha-Meda Hara property which Reduces viatiated Kapha and Meda. Hence it reduces Angasaada. Fatigue or feeling tired is the most common presenting feature of Diabetes mellitus type2 resulting from hyperglycemia and glycosuria. Therefore, when hyperglycemia is corrected with hypoglycemic activity of ingredients of Pugaarimeda Kashaya, feels relief from this symptom.

Effect of Pugaarimeda Kashaya on Biochemical parameters

Experimental studies on Puga has showed antidiabetic activity by suppressing the action of intestinal glycosidase enzymes, reduction of blood glucose level, improved insulin secretion thus reducing blood glucose level. Experimental studies on Arimeda has showed inhibitory activity against α-glucosidase type-iv enzyme, antihyperlipidemic and antioxidant activities thus reducing peripheral insulin resistance and blood glucose level.

Probable mode of action of therapy related discussion

Kashaya, Tikta Rasa of Puga and Arimeda acts as Kleda Soshana, Mutra Sangrahi and does Kapha-Meda Soshana. Laghu, Ruksha Guna does Shoshana of Kleda and acts against

Madhura-Snigdhata of Madhumeha. Katu Vipaka does Kapha Shamana, Meda Soshana, Deepana, Pachana and Kapha-Medahara property helps in improving Jatharagni and Meda Dhatvagni, so further formation of Ama, abnormal Dhatus will be prevented. Arimeda is having Kapha-Vata Hara, Meda Soshaka and Puga is having Kapha-Pittahara Karma, which is the main action in Madhumeha as it is said to be Tridoshaja. It would be effective in Samprapti Vighatana of Madhumeha.

Puga contains tannins, polyphenols, arecoline which are found effective in reducing blood sugar levels by suppressing breakdown of starch into simple sugars and improving peripheral glucose metabolism in liver, muscle adipocytes and pancreatic beta cells. It also possesses antilipidemic and antioxidant effects. Arimeda contains tannins, catechin, fisetinidol (4 alpha 6,8) which has hypoglycemic activity and n-hexocosanol, beta-amyrin, beta-sitosterol possessing hypolipidemic (reduces cholesterol, LDL) activity which in turn reduces peripheral insulin resistance.

Both the drugs help in reducing blood sugar and improving insulin sensitivity. Hence Pugaarimeda Kashaya would be effective in Samprapti Vighatana of Madhumeha. It would be beneficial in Avaranajanya Madhumeha.  

Anupana – Madhu, it is having Laghu, Ruksha Guna, Deepana, Lekhana, Medahara, Grahi, Tridosha Shamana property and is indicated in Prameha Roga.

Conclusion

Administration of Pugaarimeda Kashaya in the dosage of 100m/day in divided dose of 50ml twice daily (morning and evening) before food with 5ml Madhu as Anupana for 1 month was found beneficial in improving symptoms of Madhumeha. Statistically significant improvement was observed in Prabhoota Mutrata, Karapada Suptata and Angasaada. Statistically significant improvement was observed in objective parameters - Fasting and Post prandial blood and urine glucose levels. Research hypothesis was thus accepted.

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