E-ISSN:2456-3110

Research Article

Diabetes Mellitus

Journal of Ayurveda and Integrated Medical Sciences

2023 Volume 8 Number 11 November
Publisherwww.maharshicharaka.in

A clinical study on the effect of Lodhradi Kashaya on Madhumeha with special reference to Diabetes Mellitus (Type-2)

Mahanta N1, Sahoo P2*
DOI:10.21760/jaims.8.11.4

1 Nihar Ranjan Mahanta, Associate professor, Dept of Panchakarma, Shri Babu Singh Jay Singh Ayurvedic Medical college and Hospital, Farrukhabad, Uttar Pradesh, India.

2* Preetimayee Sahoo, Assistant Professor, Dept of Kayachikitsa, Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital, Farrukhabad, Uttar Pradesh, India.

Introduction: Ayurveda describes Prameha as a disease entity which involves a number of diseases with various physical and chemical changes in urine. Madhumeha is included under Vatik Prameha where astringency is associated with sweetness in urine. The manifestation of metabolic abnormality as well as urinary tract pathology are included in two symptoms: Prabhuta Mutrata (excessive urination) and Avila Mutrata (urine turbidity). Sedentary life style, indulgence of Kapha-meda Vardhaka Ahara, avoidance of regular exercise, day sleep indicate Santarpanajanya origin of the disease.
Methods: Lodhradi Kashaya with Lodhra, Musta, Katphal and Haritaki as described in Vasavarajeeyam is taken for this clinical study on 60 patients and its efficacy was compared with a standard drug metformin.
Results: During the study it was found that both Lodhradi Kashaya and Metformin provided significant result in improving Signs and Symptoms like polyuria, turbid urination, Polydipsia, polyphagia, burning sensation, numbness, weakness, lassitude, pruritus, muscle cramps, and increased sweating. The test of significance shows that both the trial drug and control drug were highly significant at 0.1% level with p-value <0.001 to improve glycosuria, FBS, PPBS and HbA1c in patients. Comparative analysis of the effectiveness of Lodhradi Kashaya and metformin w.r.t. objective sign and symptoms showed that both the treatments are almost equally effective to improve glycosuria, FBS, PPBS and HbA1c while Lodhradi Kashaya gives better clinical improvement than metformin in long term use in Diabetes. Lodhradi Kashaya is an efficient anti diabetic drug.

Keywords: Madhumeha, Lodhradi Kashaya, Metformin, Comparative study

Corresponding Author How to Cite this Article To Browse
Preetimayee Sahoo, Assistant Professor, Dept of Kayachikitsa, Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital, Farrukhabad, Uttar Pradesh, India.
Email: 		Mahanta N, Sahoo P, A clinical study on the effect of Lodhradi Kashaya on Madhumeha with special reference to Diabetes Mellitus (Type-2). J Ayu Int Med Sci. 2023;8(11):27-38.
Available From
https://jaims.in/jaims/article/view/2799

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2023-09-11 2023-09-16 2023-09-21 2023-09-26 2023-10-17
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
None declared Nil Yes 19.78%

© 2023by Mahanta N, Sahoo Pand 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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Nihar Ranjan Mahanta et al. Lodhradi Kashaya on Madhumeha w.s.r. to Diabetes Mellitus

Introduction

Prameha is a disease entity which comprises of a number of diseases with various physical and chemical changes in urine.[1] It is characterized by urinary disorder but it may not be inferred that all the urinary disorders caused by urinary tract pathology may be included in Prameha. The word Prameha is derived from the "Miha sechane" which means watering.[2] ‘Pra' means excess of urine in both quality and frequency. Thus, the manifestation of metabolic abnormality as well as urinary tract pathology are included in two symptoms: Prabhuta Mutrata (excessive urination) and Avila Mutrata (urine turbidity).[3] As per description if not cured or treated properly, in due course of time, Prameha changes into Madhumeha. Madhumeha is included under Vatik Prameha where astringency associated with sweetness in urine distinguishes it from Ikshumeha where urine is extremely sweet without any trace of astringency.[4,5]

Madhumeha can be related to Diabetes mellitus where the concept of hyperglycemia, polyuria and glycosuria exists. The prevalence of diabetes mellitus, which is considered as NCD (non-communicable disease), is rising all over the world due to population growth, aging, urbanization and an increase of obesity and physical inactivity. Diabetes mellitus is reaching potentially epidemic proportions in India. The level of morbidity and mortality due to diabetes and its potential complications like hypertension, dyslipidemia and obesity are enormous, and this metabolic syndrome pose significant healthcare burdens on both families and society.

There are two broad categories of DM, designated type 1 and type 2. Type 1 DM is the result of complete or near-total insulin deficiency. Type 2 DM is a heterogeneous group of disorders characterized by variable degrees of insulin resistance, impaired insulin secretion, and increased glucose production. Other etiologies for DM include specific genetic defects in insulin secretion or action, metabolic abnormalities that impair insulin secretion, mitochondrial abnormalities, and a host of conditions that impair glucose tolerance.[6] Long standing diabetes leads to several complications including neuropathy, cardiovascular diseases, renal issues, retinopathy and foot ulcer etc.[7] The IDF reported about 5 million deaths worldwide from diabetes in 2015.[8]

Diabetes is a most common metabolic disorder in India and affecting more than 30 million people with type 2 diabetes. Therapies of western medicines carry the risk of adverse effects and are often too costly especially for the developing country like India, where ethnic as well as environment also differ. Ayurveda is an indigenous ethnic medical system, which is popular practiced in the Indian subcontinent since the pre- biblical era. The system's core strength is its holistic approach to health and disease using natural remedies derived from medicinal plants and minerals. There are many popular herbs with medicinal value and which are still continued to be used in India.

In this study, an effort is being made to provide an effective oral hypoglycaemic herbal drug preparation described in our Ayurvedic texts, keeping in view its cost effectiveness, availability and safety. The trial drug ‘Lodhradi Kashaya’ was formulated as per the description in ‘Vasavarajeeyam’.[9] And eventually during my study it was found that researches and scientific evaluation of its individual components are already being carried out in pharmacological sectors proving their hypoglycaemic effect. The study has been conducted taking 60 no. of cases, divided into two groups, for a trial period of 90 days. Lodhradi Kashaya has been used as trial drug and in contrary Metformin as standard control drug.

All the clinical features and blood features; and their post development have been recorded systematically. They are assessed with the help of appropriate statistical parameters and presented in the form of tables and charts.

Aim

A clinical study on the effect of Lodhradi Kashaya on Madhumeha with special reference to Diabetes mellitus (Type-2).

Objective

1. Therapeutic evaluation of trial drug Lodhradi Kashaya.
2. Therapeutic evaluation of standard drug Metformin.
3. Comparative study of both the treatments

Hypothesis: It is assumed that “Lodhradi Kashaya” is an effective treatment to control Madhumeha


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(Type-2 Diabetes mellitus). (Ref- Vasavarajeeyam, 9th Chapter)

Materials and Methods

Following the criteria of selection, total 60 patients of Madhumeha (Type-2 Diabetes mellitus) were selected from O.P.D. and I.P.D. of G.A.M, Puri for the propose of clinical study and registered randomly into two groups i.e. Group-A and Group-B. Out of them, during the study, 3 patients of Group-A and 2 patients of Group-B discontinued the treatment. At last, 55 patients have completed the study (Table - 1).

Table 1: Showing observations of 60 patients according to registration and study completion.

GroupsGroup-AGroup-BTotal
Registered303060
Drop out325
Completed272855

Duration of study: 3 months. The assessments were carried out in each 30 days of the treatment.

Ethical clearance: With due approval by the IEC (Institutional Ethical Committee), GAM, Puri the study has been conducted among the patients registered for the purpose. Written consent was obtained from each patient participated in the study with prior proper information.

Criteria for selection of patients

Inclusion Criteria

  • Age - 30-70 years
  • Sex - Both male and female

Clinical features

a) Bahumutrata (Polyuria)
b) Trushadhikyata (Polydipsia)
c) Kshudhadhikyata (Polyphagia)
d) Dourbalya (Weakness) etc.

Biochemical Features

a) Fasting Plasma Glucose ≥ 126 mg /dl
b) Post prandial Plasma Glucose ≥ 200 mg /dl
c) Glycated Hemoglobin (HbA1c) ≥ 6.5
d) Glycosuria

Exclusion Criteria

  • Age below 30 years and above 70 years
  • Type-1 Diabetic mellitus
  • Fasting Plasma Glucose ≥ 200mg/dl
  • Angina or Myocardial Infraction
  • Nephropathy
  • Pancreatitis
  • Pregnancy
  • Pyrexia and any other systemic disorders
  • Case having medical emergencies.

Diagnostic investigations

1. FBS
2. PPBS
3. HbA1c
4. Urine-RE, ME

Posology

1. Trial drug: Lodhradi Kashaya

  • The drug was supplied in Kwatha Choorna form and 12 gms of the trial drug was boiled with 200ml water and reduced to 50ml.
  • Always fresh Kwath was made for use.
  • Dose - 50 ml BD in empty stomach.

2. Control drug: Tab. Metformin

  • Sustained release tablets of Metformin (500mg) were used.
  • Dose - Starting dose 500 mg /day in two divided doses with food
  • After assessment of FBS after 2 weeks, the dose might increase if glycemic control is not seen
  • Diet and Exercise - Patients were advised to take Pathya diet for Prameha.

Study design

1. Single group design

Group ABT vs ATEffectiveness of trial drug Lodhradi Kashaya is assessed
Group BBT vs ATEffectiveness of control drug is assessed

BT- Before Treatment, AT- After Treatment

2.Double group design

Group-AvsGroup-BEffectiveness of Lodhradi Kashayam w.r.t. Metformin will be assessed. 

Criteria of assessment

The effect of the treatments was assessed by assessing-

  • Clinical signs and symptoms before and after treatment.
  • FBS, PPBS and urine sugar levels before and after treatment.

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For the assessment of the changes, scoring method has been selected. Gradation of signs and symptoms and biochemical parameters has been done and their score before treatment and after treatment are observed.

Gradation Criteria for Specific sign and symptoms score is as follows: -

1. Prabhuta Mutrata (Polyuria)
G0 - 3 to 5 times/day, no or rarely at night
G1 - 5 to 7 times/ day, 1 to 2 times per night
G2 - 7-10 times/ day, 3-4 times per night
G3 - >10 times/ day, >5 times per night

2. Pipasadhikya (polydipsia)
G0 - Normal, 2 to 2.5 lit/ day (24 hrs)
G1 - Increased but frequency of drinking can be controlled, 2.5 to 3 lit/ day
G2 - Increased with frequency of water intake, 3 to 3.5 lit / day
G3 - Very frequent water intake, > 3.5 lit /day

3. Abila Mutrata (Turbidity in urine)
G0 - Crystal clear fluid
G1 - Faintly cloudy and smoky slight turbidity
G2 - Turbidity clearly present and newsprint easily read through test tube
G3 - Newsprint not easily read through test tube
G4 - Newsprint cannot be visualized through test tube

4. Kshudhadhikyata (Polyphagia)
G0 - Normal Appetite, 1 to 2 meals/ day
G1 - Slightly Increased, 1 to 2 meals/ day
G2 - Moderately Increased, 2 to 3 meals/ day
G3 - Markedly increased, 4 to 5 meals/ day

5. Kara-Pada Daha (Burning sensation)
G0 - No Daha
G1 - Kara-Pada Daha not continuous
G2 - Kara-Pada Daha continuous but bearable
G3- Kara-Pada Daha continuous & unbearable

6. Kara-Pada Suptata (Numbness)
G0 - No suptata
G1 - Kara-Pada Suptata not continuous
G2 - Kara-Pada Suptata continuous but bearable
G3 - Kara-Pada Suptata continuous & unbearable

7. Dourbalya (Weakness)
G0 - Can do routine exercise/ work
G1 - Can do moderate exercise with hesitancy
G2 - Can do mild exercise only, with difficulty
G3 - Cannot do mild exercise


8. Alasya/ Utsahahani (Lassitude)
G0 - No Alasya, doing satisfactory works with proper vigor and in time
G1 - Doing satisfactory works with late initiation (Likes to stand in comparison to walk)
G2 - Doing unsatisfactory works with late initiation, (likes to sit in comparison to stand)
G3 - Doing unsatisfactory works with very late initiation, (likes to lie down in comparison to sit)
G4 - Does not like to work with no initiation, (likes to sleep in comparison to lie down)

9. Kandu (Pruritus)
G0 - No itching
G1 - Mild itching, not disturbing normal activity
G2 - Occasional itching, disturbs normal activity
G3 - Itching present continuously & even disturbing sleep

10. Pindicodbestana (Cramps)
G0 - No Cramps
G1 - Cramps after walking more than 1 km
G2 - Cramps after walking ½ km
G3 - Unable to walk even ½ km

11. Nidradhikyata (Sleep)
G0 - 6-8 hrs/ day (24 hrs) with feeling of lightness
G1 - Sleep for 8-9 hrs/ day with slightly heaviness in body
G2 - Sleep for 9-10 hrs/ day with heaviness in body associated with Jrimbha
G3 - Sleep for >10 hrs/ day with heaviness in body associated with Jrimbha and Tandra

12. Swedadhikya (Excess Perspiration)
G0 - Sweating after some strenuous or heavy work or in hot and humid weather
G1 - Profuse sweating after moderate work and movement
G2 - Sweating after little extra work than routine and movement
G3 - Profuse sweating after routine work
G4 - Sweating even at rest or in cold climate

13. Glycosuria
G0 - Absent
G1 - 0.1 – 0.5 mg
G2 - 0.6 – 1.0 mg
G3 - 1.1 – 1.5 mg
G4 - 1.6 – 2.0 mg

14. Fasting Blood Sugar (FBS)
G0 - < 126 mg/dl
G1 - 126 - 150 mg/dl


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G2 - 151 - 175mg/dl
G3 - 176 - 200 mg/dl

15. Post Prandial Blood Sugar (PPBS)
G0 - < 200 mg/dl
G1 - 200 – 249 mg/dl
G2 - 250 – 300 mg/dl
G3 - 300 – 300 mg/dl

16. HbA1c
G0 - < 6.5
G1 - 6.5 – 6.9
G2 - 7.0 – 7.4
G3 - 7.5 – 7.9
G4 - ≥ 8.0

Assessment for result

Table 2: Showing the degree of severity of different clinical sign and symptoms before treatment in Group-A and Group-B.

Sign/ SymptomGroup-A (N1=27)Group-B (N2=28)
Degree of severityDegree of severity
G1G2G3G4TotalG1G2G3G4Total
Subjective sign and symptoms
Polyuria01611-2711512-28
Turbid Urination2060-2615130-28
Polydipsia01611-2711512-28
Polyphagia440-8710-8
Burning sensation7140-2110100-20
Numbness981-18470-11
Weakness1251-273213-27
Lassitude120-3380-11
Pruritus570-12352-10
Muscle cramps8140-229120-21
Excess Sleep100-1410-5
Increased sweating330-6240-6
Objective sign and symptoms
Glycosuria00324271222328
FBS10116-2711134-28
PPBS12105-2712114-27
HbA1c81063279108128

N1, N2= No. of patients in respective group; G1, G2, G3, G4 are the degree of severity

Table 3: Showing the degree of severity of different clinical sign and symptoms after 30 days of treatment in Group-A and Group-B

Sign/ SymptomGroup-A (N1=27)Group-B (N2=28)
Degree of severityDegree of severity
G0G1G2G3G4TotalG0G1G2G3G4Total
Subjective sign and symptoms
Polyuria014130-27214120-28
Turbid Urination91700-26111700-28
Polydipsia014130-27214120 28
Polyphagia3410-82600-8
Burning sensation111000-2111810-20
Numbness31320-180920-11
Weakness71820-2751930-27
Lassitude0300-33800-11
Pruritus3630-121720-10
Muscle cramps15700-2261410-21
Excess Sleep1000-10500-5
Increased sweating2400-62400-6
Objective sign and symptoms
Glycosuria058113270659828
FBS31680-2751940-28
PPBS41940-2771820-27

N1, N2= No. of patients in respective group; G0, G1, G2, G3, G4 are the degree of severity

The degree of severity as per above gradation criteria and data was collected from pathological investigations before treatment (BT) (Table -2), after 30 days (AT1) (Table 3), 60 days (AT2) (Table 4) and 90 days (AT3) (Table 5) of treatment and were assessed. The assessment has been done in two stages as follows-

Table 4: Showing the degree of severity of different clinical sign and symptoms after 60 days of treatment in Group-A and Group-B.

Sign/ SymptomGroup-A (N1=27)Group-B (N2=28)
Degree of severityDegree of severity
G0G1G2G3G4TotalG0G1G2G3G4Total
Subjective sign and symptoms
Polyuria131400-27141400-28
Turbid Urination25100-2628000-28
Polydipsia91800-27161200-28
Polyphagia7100-88000-8
Burning sensation21000-2141510-20
Numbness61200-182900 11
Weakness22500-2720700-27
Lassitude3000-311000-11
Pruritus10200-128200-10
Muscle cramps22000-2219200-21
Excess Sleep1000-11400-5
Increased sweating6000-66000-6
Objective sign and symptoms
Glycosuria8108012771272028
FBS161100 27161200 28
PPBS171000 2718900 27

N1, N2= No. of patients in respective group; G0, G1, G2, G3, G4 are the degree of severity

Table 5: Showing the degree of severity of different clinical sign and symptoms after 90 days of treatment in Group-A and Group-B.

Sign/ SymptomGroup-A (N1=27)Group-B (N2=28)
Degree of severityDegree of severity
G0G1G2G3G4TotalG0G1G2G3G4Total
Subjective sign and symptoms
Polyuria25200-2724400-28
Turbid Urination26000-2628000-28
Polydipsia26100-2728000-28
Polyphagia8000-828000-8
Burning sensation21000-21101000-20
Numbness11700-186500 11
Weakness27000-2727000-27
Lassitude3000-311000-11
Pruritus12000-1210000-10
Muscle cramps22000-2221000-21
Excess Sleep1000-14100-5
Increased sweating6000-66000-6
Objective sign and symptoms
Glycosuria243000271981  28
FBS252000272710  28
PPBS261000272610  27
HbA1c2070002719900028

N1, N2= No. of patients in respective group; G0, G1, G2, G3, G4 are the degree of severity


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Clinical assessment

The percentage of patients got improved and the average percentage improvement in the severity of different clinical sign and symptoms was calculated. The overall clinical assessment has been done considering the sign and symptoms as follows-

1. Well Controlled: 100% relief in signs and symptoms like polyuria, polydipsia, polyphagia, turbid urination, weakness, glycosuria, FBS and PPBS in Trial Period.
2. Maximum Control: 75- 99% relief in signs and symptoms.
3. Moderate Control: 50- 74% relief in signs and symptoms.
4. Mild Control: 25- 49% relief in signs and symptoms.
5. Unsatisfactory: < 25% relief in signs and symptoms.

Statistical analysis

The objective data, like levels of Glycosuria, FBS, PPBS and HbA1c, gathered from the patients was subjected for statistical analysis. Data were analyzed statistically in terms of Mean, Standard Deviation (S.D.), Standard Error (S.E.), t-value and p- value. The statistical analysis after 30 days (AT1), 60 days (AT2) and 90 days of treatment (AT3) has been done. For the effectiveness of trial drug and control drug paired ‘t’ test and unpaired t- test has been used. The effectiveness of trial drug and control drug has been assessed through the p- value. The p-value was interpreted as-

1. >0.05 statistically insignificant at 5% level
2. <0.05 significant at 5% level
3. <0.01 significant at 1% level
4. <0.001 highly significant at 0.1% level

Results and Discussion

The present clinical study conducted at Dept. of Kayachikitsa GAM, Puri includes Madhumeha patients from both the sexes within the age group of 30-70 years. Only Type 2 DM cases without any complications were accepted and all the cases of Type 1 DM and Type 2 DM with any complication were excluded.

The cause of exclusion is that the type 1 DM cases do not respond to oral hypoglycaemic agents, so insulin is inevitable for them. Also Type 2

DM cases with any complications would need another associated medication simultaneously. In both these cases the study results would be erroneous, thus excluded.

Clinical assessment of result

The clinical assessment was done basing on the sign and symptoms, polyuria, Turbid urination, polydipsia, polyphagia, weakness, glycosuria, FBS and PPBS which were provided with gradation for proper assessment. To declare the result certain scales were formulated and the language against recovery was fixed as well controlled, maximum control, moderate control, mild control and unsatisfactory.

Table 6 : Showing Clinical assessment of Result in Group-A and Group-B

Clinical AssessmentAT1AT2AT3
Group-AGroup-BGroup-AGroup-BGroup-AGroup-B
F%f%f%f%f%f%
Well Controlled0000414.81414.292281.481864.28
Maximum Control311.12310.711555.561864.28518.521035.71
Moderate Control1244.441553.57829.62621.430000
Mild Control1244.441035.7200000000
Unsatisfactory000000000000

The clinical assessment of result in Group-A (Trial Group) and Group-B (Control Group) presented that, after 30 days of treatment 11.12% got maximum control, 44.44% each got moderate and mild control in Group-A. After 60 days of treatment 14.81% got well controlled, 55.56% got maximum control, and 29.62% each got moderate control. After 90 days, 81.48% got well controlled and 18.52% got maximum control.

In the other side after 30 days of treatment Group-B got 10.71% maximum control, 53.57% moderate control and 35.72% mild control. After 60 days of treatment 14.29% got well controlled, 64.28% got maximum control and 21.43% got moderate and mild control. After 90 days of treatment 64.28% got well-controlled and 35.72% got maximum control. This shows that long term use of the trial drug in Group-A shows better response than the control drug in Group-B with higher percentage of improvement.

Statistical analysis

Statistical analysis was done basing on the objective parameters (i.e. glycosuria, FBS, PPBS and HbA1c) fixed under the assessment scale. Analyzing the effectiveness of treatment -1 and treatment -2 (Table no-7), the test of significance shows


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that both the trial drug and control drug were highly significant at 0.1% level with p-value <0.001 to improve glycosuria, FBS, PPBS and HbA1c. Statistical analysis of the effectiveness of Lodhradi Kashaya in comparison to metformin w.r.t. objective sign and symptoms (Table no. 8) showed that both the treatments are almost equally effective to improve glycosuria, FBS, PPBS and HbA1c.

Table 7 : Statistical analysis showing the effectiveness of treatment-1 and treatment-2 with respect to the sign and symptoms.

Sign/ SymptomGroup  Mean ± SDMean diff ±SDdfSEtpRemarks
GlycosuriaGroup-ABT1.94 ± 0.16      
AT11.19 ± 0.520.75 ± 0.47260.0918.2663< 0.001*
AT20.45 ± 0.531.49 ± 0.51260.09815.2571< 0.001*
AT30.03 ± 0.101.92 ± 0.18260.03555.4375< 0.001*
Group-BBT1.84 ± 0.39      
AT11.28 ± 0.660.58 ± 0.49270.0926.0798< 0.001*
AT20.44 ± 0.501.40 ± 0.51270.09714.4201< 0.001*
AT30.06 ± 0.191.78 ± 0.40270.07623.2336< 0.001*
FBSGroup-ABT159.85 ± 15.38      
AT1139.56 ± 12.5620.30 ± 6.75261.29815.6307< 0.001*
AT2122.78 ± 11.7037.07 ± 8.38261.61322.9883< 0.001*
AT3108.89 ± 11.0750.96 ± 8.68261.67130.4922< 0.001*
Group-BBT158.54 ± 14.48      
AT1136.75 ± 11.5221.79 ± 6.91271.30716.6731< 0.001*
AT2121.50 ± 11.8837.04 ± 7.10271.34327.5829< 0.001*
AT3107.57 ± 10.6950.96 ± 7.78271.4734..6768< 0.001*
PPBSGroup-ABT267.41 ± 36.38      
AT1226.26 ± 23.3747.15 ± 18.07263.47813.5548< 0.001*
AT2190.63 ± 19.5276.78 ± 22.14264.26118.0194< 0.001*
AT3167.81 ± 17.3399.59 ± 27.32265.25818.9399< 0.001*
Group-BBT256.89 ± 35.77      
AT1214.61 ± 24.2142.29 ± 20.63273.89910.8458< 0.001*
AT2184.39 ± 20.7372.50 ± 26.21274.95314.6389< 0.001*
AT3162.18 ± 18.2994.71 ± 26.76275.05618.7321< 0.001*
HbA1cGroup- ABT7.31 ± 0.47      
AT36.29 ± 0.311.02 ± 0.30260.05817.3775< 0.001*
Group- BBT7.18 ± 0.46      
AT36.14 ± 0.411.04 ± 0.16270.03133.9333< 0.001*

S.D= standard deviation, df= Degree of freedom, t= test of significance, p=probability; * = Highly significant at 0.1% level.

Table 8: Statistical analysis showing the effectiveness of Lodhradi Kasaya in comparison to Metformin w.r.t. sign and symptoms after 30 days, 60 days and 90 days.

Sign/ SymptomTreat. PeriodAssessment typeMean diff ± SDSE of diff.dft-valuep-valueRemarks
GlycosuriaAT30Group-A Vs Group-B0.75 ± 0.470.129531.5073> 0.05*
0.58 ± 0.49
AT60Group-A Vs Group-B1.49 ± 0.510.138530.6985> 0.05*
1.40 ± 0.51
AT90Group-A Vs Group-B1.92 ± 0.180.085531.6901> 0.05*
1.78 ± 0.40
FBSAT30Group-A Vs Group-B20.30 ± 6.751.843530.8082> 0.05*
21.79 ± 6.91
AT60Group-A Vs Group-B37.07 ± 8.382.092530.0183> 0.05*
37.04 ± 7.10
AT90Group-A Vs Group-B50.96 ± 8.682.221530.0006> 0.05*
50.96 ± 7.78
PPBS AT30Group-A Vs Group-B47.15 ± 18.07 5.238 53 0.9284 > 0.05*
42.29 ± 20.63
AT60Group-A Vs Group-B76.78 ± 22.146.553530.6528> 0.05*
72.50 ± 26.21
AT90Group-A Vs Group-B99.59 ±27.327.292530.669> 0.05*
94.71 ± 26.76
HbA1cAT90Group-A Vs Group-B1.02 ± 0.30 0.065 53 0.3205 > 0.05*
1.04 ± 0.16

S.D= standard deviation, SE diff.= Standard error of difference, df= Degree of freedom, t= test of significance, p=probability;  = Insignificant at 5% level.

Mode of action of Trial Drug

The trial drug Lodhradi Kashaya contains four constituents namely Lodhra, Musta, Haritaki and Katphala. Each one is reported in Ayurvedic classics to have action of reducing Prameha.[10,11] From Rasa Panchaka analysis it has been observed that-

  • There is predominance of Kashaya, Tikta and Katu Rasa; Laghu, Tikshna and

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  • Ruksha Guna; Ushna Virya and Katu Vipaka. Hence the drug acts as Kapha Shamana by virtue of its Rasa, Guna, Virya and Vipaka; Pitta Shamana with Madhura Rasa and Seeta Virya; Vata Samana with Madhura Rasa, Ushna Virya and Madhura Vipaka. As a whole the drug acts as Tridosha Samaka. Hence effective in controlling Madhumeha.
  • Most of the drugs are having Kapha-Medahara property which ultimately corrects the vitiated Slesma, Meda and Mamsa Dhatu.
  • All the herbs are having Deepan-Pachan property. Thus, the prepared medicine is potential to correct the Agni i.e., Jatharagni and Dhatwagni. They help in smooth management of body metabolism. Ultimately it helps in proper nourishment of Dhatus. It has the capacity to improve the tones of Sapta-Dhatus.
  • Madhumeha is a disease related to Mutrabaha Srotas with cardinal symptom of polyuria (Prabhuta Mutrata). Most of the drugs are having Grahi and Stamhbhana property with predominance of Kashaya (astringent) and Tikta (bitter) Rasa as well. These helps to decrease excess urination and prevent the system from vitiation.
  • Haritaki clears all the Srotas (paths) so it is called as Pathya. It alleviates the Margabarodha (obstructions) in Madhumeha. It also nourishes all Dhatus with its Rasayana property.
  • Musta is potent in Trishna Nigrahana. So, it corrects the Purbarupa stage like Trishna, Galatalu Sosha etc. in Madhumeha.
  • Raj Nighantu describes Katphala as Ugradahahara. Musta also have Daha Nasaka property. It cures the burning and tingling sensations in upper and lower extremities (Hastapada Daha).
  • Lodhra is having Chakshushya (good for eyes) property, which may alleviate the chances of retinal complications in type 2 DM.

Hence from Ayurvedic point of view Lodhradi Kashaya is capable enough to fulfil all the treatment modalities of Madhumeha (type 2 DM).

Modern science strengthens the concept of Madhumehaghna (antidiabetic) property of all the four herbs. It is believed that the basis of the chemical constitution of different

herbal drugs and various medicinal/ plant extracts contain active flavonoids, alkaloids, phenolic compounds, terpinoids, saponins, and phytosterol type chemical constituents that are effective in the management of diabetic complications. This effect might be attributed to the amelioration of persistent hyperglycemia, oxidative stress, and modulations of various metabolic pathways involved in the pathogenesis of diabetic complications.[12]

  • The experimental studies on antidiabetic activities of Lodhra (Symplocos racemose), Musta (Cyperus rotundus), Haritaki (Terminalia chebula) and Katphala (Myrica esculenta) has been cited in the drug review section.
  • Experimental studies show a significant reduction in blood glucose levels in DM animal models.
  • Brahmakar R.B. et al. has reported the hypoglycemic effects of Lodhradi Kashaya. In their study, Lodhradi Kashaya Ghana Vati (LKGV) showed a significant decrease in blood sugar level both compared to a diabetic non-treated control group and to a group treated with a standard anti-diabetic drug, glibenclamide, in a streptozotocin- induced hyperglycemic rat model. It is reported that LKGV acts by stimulating the pancreatic beta cells of the pancreas and increasing sensitivity of the peripheral tissue to insulin.[13]
  • All the components of the trial drug have antioxidant, antibacterial, antifungal, antiulcer, hepato-protective, hypolipidemic and anti-inflammatory activities.[14-17]

The above data proves that the trial drug Lodhradi Kashaya is capable enough to manage Madhumeha (type-2 DM) in all aspects.

Conclusion

Madhumeha is a Tridoshaja Vyadhi with the main culprit Dosha- Kapha and Vata. Diabetes mellitus, which is a metabolic disorder, can be compared with Madhumeha according to presentation of disease as well as according to etiological factors involved. Sedentary life style, indulgence of Kapha-Meda Vardhaka Ahara, avoidance of regular exercise, day sleep is such findings of study which indicate Santarpanajanya origin of disease. Taking in to consideration into the various observations, results obtained during study and discussion,


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it can be said that Both Lodhradi Kashaya and Metformin provided significant result in improving Signs and Symptoms. Both drugs had improved levels of Glycosuria, F.B.S., P.P.B.S. and HbA1c in patients. Lodhradi Kashaya gives better clinical improvement than metformin in long term use. Hence it is proved to be an efficient anti diabetic drug.

References

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2. Joshi JS, editor. (3rd Ed.) Abhidhana Ratnamala of Halayudha Bhatta. Lucknow: Uttar Pradesh Hindi Sansthan; 1993. p. 544.

3. Acharya YT, editor. (Reprint Ed.) Nibandhasamgraha Tika of Dalhana and Nyaya Chandrika Tika of Gayadas on Susruta Samhita of Susruta, Nidan Sthana, Prameha Nidanam, Chapter 6, Verse 23. Varanasi: Chaukhambha Orientalia; 2014. p. 290.

4. Gaur BL, editor. (1st Ed.) Ayurveda Dipika Tika of Chakrapanidatta on Charak Samhita of Agnivesha, Vol-II, Nidan Sthan, Prameha Nidan: Chapter 4, Verse 19. New Delhi: Rastriya Ayurveda Vidyapeetha; 2014. p. 121.

5. Gaur BL, editor. (1st Ed.) Ayurveda Dipika Tika of Chakrapanidatta on Charak Samhita of Agnivesha, Vol-II, Nidan Sthan, Prameha Nidan: Chapter 4, Verse 44. New Delhi: Rastriya Ayurveda Vidyapeetha; 2014. p. 130.

6. Harrison’s Principle of Internal Medicine. 19th edition. Page 2399.

7. Ramachandran A, et al. High prevalence of Diabetes and impaired glucose tolerance in India; National Urban Diabetes Survey. Diabetologia. 2001;3(8):488-94.

8. IDF Diabetes Atlas 2010.

9. Pandey G. (1st Ed.) Commentary on Vasavarajeeyam of Vasavaraj, 9th prakarana. Varanasi: Chaukhamba Krishnadas Prakashan; 2010. p. 286.

10. Mahanta NR, et al. Lodhradi Kashaya as a Potent Antidiabetic Agent: A Drug Review. World Journal of Pharmaceutical Research. 2022;11(3):1115-1129.

11. Singh, & Ramachandra Reddy, Konduru. (2017). Review on Lodhradi Kashaya: All-rounder remedy for Diabetes mellitus patients. Indian journal of traditional knowledge. 16. 100-106.

12. Singh R, et al. Management of diabetic complications: A chemical constituent-based approach. J Ethnopharmacol 2013;150;51-70.

13. Bramhankar RB, Reddy KRC, Trigunayat A. Hypoglycemic effect of Lodhradi Kashaya Ghanavati in streptozotocin –induced hyperglycemia in rats. International Journal of Green Pharmacy. Oct-Dec 2015. 9(4)/241-245.

14. Singh VK, Reddy KRC. Management of Diabetes mellitus and its complications by Lodhra: A review. International Journal of Ayurvedic Medicine. 2015;6(4):305-309.

15. N Singh, et al. Phyto-pharmacotherapeutics of Cyperus rotundus Linn. (Motha): An overview. Indian Journal of Natural Products and Resources. Vol. 3(4), December 2012, pp. 467-476.

16. Gupta et al. Biological and pharmacological properties of Terminalia chebula Retz. (Haritaki)- an overview. Int J Pharm Sci. Vol 4, Suppl 3, 62-68.

17. Joshi et al. Myrica nagi: a review on active constituents, biological and therapeutic effects. Int J Pharm Pharm Sci. Vol 4, Suppl 5, 38-42.


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