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CTRI Number  CTRI/2025/12/099036 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 12/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A efficacy study of an Ayurvedic Decoction (Kadha) Varadi Kashaya to reduce HbA1c in patients of Type 2 Diabetes Mellitus as compared to Standard Medications 
Scientific Title of Study   Efficacy and safety of Ayurvedic polyherbal decoction Varadi Kashaya to reduce Glycated Hemoglobin (HbA1c) in patients of Type 2 Diabetes Mellitus as compared to standard of care in Bharati Ayurved Hospital Pune, A randomized controlled proof of concept trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Advait Murli Menon 
Designation  Assistant Professor 
Affiliation  Bharati Vidyapeeth (Deemed to be University) College of Ayurved  
Address  Bharati Vidyapeeth (Deemed to be University) College of Ayurved Hospital, 1st floor, Department of Roga Nidan evam Vikriti Vigyan, Dhankawdi campus, Pune 411043
Bharati Vidyapeeth (Deemed to be University) College of Ayurved Hospital, 2nd floor, Department of Kayachikitsa, Dhankawdi campus, Pune 411043
Pune
MAHARASHTRA
411043
India 
Phone  07875150722  
Fax    
Email  ssadvaitmenon93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Advait Murli Menon 
Designation  Assistant Professor 
Affiliation  Bharati Vidyapeeth (Deemed to be University) College of Ayurved  
Address  Bharati Vidyapeeth (Deemed to be University) College of Ayurved Hospital, 1st floor, Department of Roga Nidan evam Vikriti Vigyan, Dhankawdi campus, Pune 411043
Bharati Vidyapeeth (Deemed to be University) College of Ayurved Hospital, 2nd floor, Department of Kayachikitsa, Dhankawdi campus, Pune 411043
Pune
MAHARASHTRA
411043
India 
Phone  07875150722  
Fax    
Email  ssadvaitmenon93@gmail.com  
 
Details of Contact Person
Public Query  
Name  Advait Murli Menon 
Designation  Assistant Professor 
Affiliation  Bharati Vidyapeeth (Deemed to be University) College of Ayurved  
Address  Bharati Vidyapeeth (Deemed to be University) College of Ayurved Hospital, 1st floor, Department of Roga Nidan evam Vikriti Vigyan, Dhankawdi campus, Pune 411043
Bharati Vidyapeeth (Deemed to be University) College of Ayurved Hospital, 2nd floor, Department of Kayachikitsa, Dhankawdi campus, Pune 411043
Pune
MAHARASHTRA
411043
India 
Phone  07875150722  
Fax    
Email  ssadvaitmenon93@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth (Deemed to be University) College of Ayurved 
 
Primary Sponsor  
Name  Bharati Vidyapeeth Deemed to be University College of Ayurved 
Address  Bharati Vidyapeeth (Deemed to be University), Pune 411030 
Type of Sponsor  Other [Private (Deemed to be) University] 
 
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 Advait Menon  Bharati Vidyapeeth Ayurved Hospital  Bharati Vidyapeeth (Deemed to be University) College of Ayurved Hospital, 1st floor, Department of Roga Nidan evam Vikriti Vigyan, Dhankawdi campus, Pune 411043
Pune
MAHARASHTRA 		 07875150722

ssadvaitmenon93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth Deemed to be University College of Ayurved  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Varadi Kashaya, Reference: Charak Sutrasthan 23/10-11, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 80(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Standard of Care Oral AntihyperglycemicsHbA1c of 6.5 to 7.5 Metformin upto 2 gms OD or BD as directed by physician. HbA1c 7.6 to 8 Metformin upto 2 gms and or Glimepiride upto 2 mg OD or BD as directed by physician
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Newly diagnosed patients with HbA1c more than 6.5 % up to 8 % not taking any standard of care

Patients from all socioeconomic condition  
 
ExclusionCriteria 
Details  Patient involved in any diabetic trial in recent time. Patients having any hemolytic conditions. Known case of Gestational diabetes. Known case Patients of type 1 Diabetes mellitus. Known case of Diabetes Mellitus associated with systemic viral/bacterial infections like HIV, Hepatitis, Tuberculosis and Malignancy etc 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine Efficacy of Varadi Kashaya to achieve glycemic control in 90 days as compared to standard of care in type 2 Diabetes Mellitus patients  DAY - 0, 90 
 
Secondary Outcome  
Outcome  TimePoints 
To determine efficacy in rate of Varadi Kashaya to achieve glycemic control in comparison to standard care in type 2 Diabetes Mellitus patients  DAY - 0, 30, 60, 90 
To determine efficacy of Varadi Kashaya on insulin resistance in type 2 Diabetes Mellitus patients  DAY- 0, 90 
To determine efficacy of Varadi Kashaya on Lipid profile in type 2 Diabetes Mellitus patients  DAY - 0, 90 
To determine the safety of Varadi Kashaya   DAY - 90 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   24/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ssadvaitmenon93@gmail.com].

  6. For how long will this data be available start date provided 16-06-2026 and end date provided 31-12-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

The current study determines the efficacy of a poly herbal formulation Varadi Kashaya (decoction) expounded in the classic text of Charak Samhita. This study also compares the Investigational drug (ID) with standard of care and its effectiveness in glycemic control. Both the groups will be tested for effect on insulin resistance, lipid dysfunction and safety. Although it is a non inferiority trial, if Varadi Kashaya is found to be superior than the Standard of care to achieve glycemic control it will be reported.


 
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