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CTRI Number  CTRI/2024/08/073058 [Registered on: 28/08/2024] Trial Registered Prospectively
Last Modified On: 28/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [ayurvedic intervention]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Efficacy of Ayurvedic formulations in pre diabetes and Type 2 Diabetes  
Scientific Title of Study   Randomized active comparator controlled clinical trial of selected Ayurvedic formulations in pre diabetes and Type 2 Diabetes  
Trial Acronym  No Acronym 
Secondary IDs if Any  
Secondary ID  Identifier 
I-Nature-T2D-01 protocol version 2024-06-03  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Srikanta 
Designation  Medical Director and distinguished consultant endocrinology Diabetes 
Affiliation  Samatvam Science and Research for Human Welfare Trust 
Address  number 2 1A cross Marenahalli J P Nagar phase 2 Bengaluru

Bangalore
KARNATAKA
560078
India 
Phone  8026493040  
Fax    
Email  samatvam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S Srikanta 
Designation  Medical Director and distinguished consultant endocrinology Diabetes 
Affiliation  Samatvam Science and Research for Human Welfare Trust 
Address  number 2 1A cross Marenahalli J P Nagar phase 2 Bengaluru


KARNATAKA
560078
India 
Phone  8026493040  
Fax    
Email  samatvam@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S Srikanta 
Designation  Medical Director and distinguished consultant endocrinology Diabetes 
Affiliation  Samatvam Science and Research for Human Welfare Trust 
Address  number 2 1A cross Marenahalli J P Nagar phase 2 Bengaluru


KARNATAKA
560078
India 
Phone  8026493040  
Fax    
Email  samatvam@gmail.com  
 
Source of Monetary or Material Support  
Ministry of AYUSH Government of India 
 
Primary Sponsor  
Name  Ministry of AYUSH Government of India 
Address  AYUSH Bhawan B Block GPO complex INA New Delhi 110023 
Type of Sponsor  Government funding agency 
 
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 S Srikanta  Samatvam Science and Research for Human Welfare Trust  Room number 1 first floor Endocrinology department building Number 2 Jnana sanjeevini Marenahalli J P Nagar phase 2 Bengaluru 560078
Bangalore
KARNATAKA 		 8026493040

samatvam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Science for Health   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Varadi Ghana Vati, Reference: Sharangadhara samhita madhyama khanda chapter 2 shloka 108, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 3000(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 2 Years, anupAna/sahapAna: Yes(details: water), Additional Information: NIL
2Comparator Arm (Non Ayurveda)-Metformin Given in a dosage of 500 mg TID before food for a duration of 2 years orally
3Intervention ArmDrugClassical(1) Medicine Name: Mustadi Ghana Vati, Reference: Gadanigraha Kayachikitsa Khanda Pramehadhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 3000(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 2 Years, anupAna/sahapAna: Yes(details: water), Additional Information: NIL
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects of either sex
Group A type 2 diabetes drug naive HbA1c 7 to 9 percentage
Group B Type 2 diabetes on metformin monotherapy HbA1c 7 to 9 percentage
Group C prediabetes drug naive HbA1c 5.7 to 6.4
non hypertensive or controlled hypertensive
agree for written informed consent 
 
ExclusionCriteria 
Details  type 1 diabetes mellitus
diabetic complications, hypertension
Hb less than 10
pregnant and lactating women
LFT RFT TSH and lipid profile under abnormal limits
psychiatric illness 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
changes in HbA1c glycated serum protein albumin   Baseline and at 1 3 6 12 18 and 24 months  
 
Secondary Outcome  
Outcome  TimePoints 
Change in cystinallated truncated and di or tri oxydised albumin
changes in HOMA 2 IR and HOMA 2 B
Changes in FBS PPBS lipid profile LFT HSCRP Sr Creat e GFRand urine albumin creatinine ratio
Change in DSQ and ASQ scores 		 baseline and at 1 3 6 12 18 and 24 months 
 
Target Sample Size   Total Sample Size="324"
Sample Size from India="324" 
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 2/ Phase 3 
Date of First Enrollment (India)   10/09/2024 
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="3"
Months="0"
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 - 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 - Informed Consent Form
    Response - Clinical Study Report

  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 [samatvam@gmail.com].

  6. For how long will this data be available start date provided 20-08-2027 and end date provided 20-08-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a Randomized Active Comparator phase 2 or 3 clinical trial on pre diabetes and type 2 diabetes using ayurvedic polyherbal formulations with Metformin as comparator. Total duration of intervention is 2 years. The sample size is 324 including 3 groups, 108 subjects in each group.  
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