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CTRI Number  CTRI/2022/04/042194 [Registered on: 27/04/2022] Trial Registered Prospectively
Last Modified On: 30/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Comparative Study to evaluate the efficacy of Patha Vidanga Arjuna Dhanvana Kwath with conventional medicine alone in control of “Metabolic Syndrome" 
Scientific Title of Study   A Comparative Study to evaluate the efficacy of Patha Vidanga Arjuna Dhanvana Kwath with conventional medicine alone in control of “Metabolic Syndrome” in Urban Population of an area in an Urbanised Indian State 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhanwantarikumar Harinath Jha 
Designation  Ph.D Scholar 
Affiliation  Dr D Y Patil College Of Ayurved and research centre, Pimpri, Pune 
Address  Department of Kayachikitsa, Dr D Y Patil College Of Ayurved and research centre, Pimpri, Pune
Dr D Y Patil College Of Ayurved and research centre, Pimpri, Pune
Pune
MAHARASHTRA
411 018
India 
Phone  9998270582  
Fax    
Email  dhanwantari4u@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gunvant Hari Yeola 
Designation  Principal, Professor 
Affiliation  Dr D Y Patil College Of Ayurved and research centre, Pimpri, Pune 
Address  Dept. of Kayachikitsa, Dr D Y Patil College Of Ayurved and research centre, Pimpri, Pune
Dr D Y Patil College Of Ayurved and research centre, Pimpri, Pune
Pune
MAHARASHTRA
411 018
India 
Phone  9028321955  
Fax    
Email  principal.ayurved@dypvp.edu.in  
 
Details of Contact Person
Public Query  
Name  Dhanwantarikumar Harinath Jha 
Designation  Ph.D Scholar 
Affiliation  Dr D Y Patil College Of Ayurved and research centre, Pimpri, Pune 
Address  Dr D Y Patil College Of Ayurved and research centre, Pimpri, Pune

Pune
MAHARASHTRA
411 018
India 
Phone  9998270582  
Fax    
Email  dhanwantari4u@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil College Of Ayurved and research centre, Pimpri, Pune 
 
Primary Sponsor  
Name  Dhanwantarikumar Harinath Jha 
Address  Dr D Y Patil College Of Ayurved and research centre, Pimpri, Pune 411 018 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dhanwantarikumar Harinath Jha  Dr. D. Y. Patil Ayurved Hospital, Pimpri, Pune  Kayachiktsa OPD No. 1, Dr. D.Y.Patil Ayurveda Hospital, Dr. D. Y. Patil College of Ayurved & Research Centre, Pimpri, Pune-411 018 (Maharashtra) India
Pune
MAHARASHTRA 		 9998270582

dhanwantari4u@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Dr. D. Y. Patil Vidyapeeth, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E888||Other specified metabolic disorders. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Patha Vidanga Arjuna Dhanvana Kwath, Reference: Charak Samhita, Chikitsa Sthan, Chapter 6, Prameha Chikitsa Shloka No. 27 - (Second Kwath Mentioned) , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmLifestyle--Dinacarya: Daily Walking on empty stomach for 45 minutes, Ritucarya: , Acara Rasayana:, Other:Daily practice of Yoga for 15 minutes every morning on empty stomach 1)Half-Fish Pose (Ardha Matsyendrasana), 2)Paschimottanasana, 3)Adomukhisvanasana, 4)Vajrasana, Pathya/Apathya:yes, Pathya:lukewarm water, sorghum, atleast 1 year old grains, easily digestible foods, Green gram. , Apathya:Sweet foods, cold water, Fruits with high Glycemic index, Curd, Domesticated animals meat, Day time sleep, New grains, dairy products, maida items and fatty foods.
3Comparator Arm (Non Ayurveda)-Blood pressure may be treated with: Diuretics Angiotensin converting enzyme inhibitors Beta blockers Calcium channel blockers Blood glucose may be treated with: Metformin Glitazones Alpha-glucosidase inhibitors Orlistat Triglycerides may be treated with: Statins Fibrates Niacin Omega-3 fatty acids Obesity may be treated with: Orlistat etc. The dosage may vary according to the disease and patient condition.
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details 
o Age 40-65 Yrs.
o Patients with Metabolic syndrome according to NCEP ATP3 Criteria.
 
 
ExclusionCriteria 
Details  1) Age <40yrs. and >65yrs.
2) With associated heart disease or other secondary complications. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in following criteria which are base for diagnosis of Metabolic Disorder:

Central obesity: Waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 35 inches(female)

TG ≥ 1.7 mmol/L (150 mg/dl)

HDL-C 40 mg/dL (male), 50 mg/dL (female)

Blood pressure ≥ 130/85 mmHg (or treated for hypertension)
Fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dl) 		 At the end of 30 days, 60 days and 90 Days. 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Quality of life:
Based on the signs & symptoms reported by the patients before and after treatment, relief in mental & physical health will be accessed on the basis of grading developed for these clinical factors and it will be followed by statistical analysis. 		 At the end of 1st Month, 2nd Month and 3rd Month. 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   06/06/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dhanwantari4u@yahoo.com].

  6. For how long will this data be available start date provided 16-01-2023 and end date provided 14-04-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 The Metabolic Syndrome is a cluster of factors, namely central obesity, glucose intolerance, low amount of High-density lipoprotein (HDL), high triglycerides (TG) and systemic hypertension. It has a high prevalence rate with more than 10 million cases per year In India. In India, recent rise in Metabolic Syndrome has been attributed to the shift in lifestyles, both in the urban and in the rural areas. Metabolic Syndrome has the potential to double the risk of cardiovascular diseases, which is one of the major leading causes of adult death. Metabloic syndrome usually requires a team work of Endocrinologists, Cardologists and Nutritionists. Ayurveda being a Holistic system of Medicine can single handedly handle this complex condition with its Dosha based treatment system. And moreover it directly falls under the category of Sthula Pramehi (Obese Diabetic) which is clearly and elaborately mentioned in our texts along with its management. Thus, Ayurveda already has what it takes to manage Metabolic Syndrome well and that too without inducing any adverse effects of drugs. The Prameha chapter of Chikitsa sthan of Charak Samhita mentions many formulations for the management of different types of Prameha’s. For the management of Kaphaj Prameha there is a mention of 10 kwath formulations: हयीतकीकट्परभुस्तरोध्रं ऩाठाविडङ्गार्ुुनधन्िनाश्च| उबे हरयद्रे तगयं विडङ्गं कदम्फशारार्ुुनदीप्मकाश्च||२७|| दािी विडङ्गं खददयो धिश्च सुयाह्वकुô€†µà¤¾à¤—ुरुचन्दनानन| दार्वमुग्ननभन्थौ विपरा सऩाठा ऩाठा च भूिाु च तथा श्वदंष्टा||२८|| मिान्मुशीयाण्मबमागुडूचीचर्वमाबमानचिकसप्तऩराु्| ऩाद ् कषामा् कपभेदहनां ते दशोऩददô€†´à¤¾ भधुसम्रमुक्ा्||२९|| We will use one of these formulations, which has a combination of Patha (Cissampelos pareira), Vidang (Embelia ribes), Arjuna (Terminalia arjuna) and Dhanvana (Grewia tiliaefolia) for our research. 
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