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CTRI Number  CTRI/2024/11/077229 [Registered on: 22/11/2024] Trial Registered Prospectively
Last Modified On: 09/11/2024
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 clinical trial to study the effect of vrundatriphaladi ghanvati as adjuvant therapy in type 2 diabetes mellitus 
Scientific Title of Study   A randomized open label controlled clinical study; to evaluate the efficacy of vrundatriphaladi ghanvati as adjuvant therapy in prameha with special reference to type 2 diabetes Mellitus.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinayak Pache 
Designation  Assistant Professor 
Affiliation  Government Ayurvedic College Dharashiviv. 
Address  Kayachikitsa Department,Room no.31 ,Tuljapur road, Dharashiv(osmanabad)

Osmanabad
MAHARASHTRA
413501
India 
Phone  9221296655  
Fax    
Email  vinu2205@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Raman Ghungralekar 
Designation  Honble Director Directorate of Ayush 
Affiliation  Directorate Of AYUSH 
Address  Govt.Dental college & Hospital Building,Ayush Department, Mumbai.

Mumbai
MAHARASHTRA
400001
India 
Phone  7021876423  
Fax    
Email  ghungralekar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Raman Ghungralekar 
Designation  Honble Director Directorate of Ayush 
Affiliation  Directorate Of AYUSH 
Address  Govt.Dental college & Hospital Building,Ayush Department, Mumbai.

Mumbai
MAHARASHTRA
400001
India 
Phone  7021876423  
Fax    
Email  ghungralekar@gmail.com  
 
Source of Monetary or Material Support  
R.A.Podar Medical College (Ayu),Dr Annie Besant road, ,worli, Mumbai,state-Maharashtra country-India. Pin 400018 
 
Primary Sponsor  
Name  R A Podar Medical College Ayu 
Address  Dr.Annie Besant Road, worli Mumbai.state-Maharashtra.Country-India Pin - 4000018 
Type of Sponsor  Research institution and hospital 
 
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 Vinayak Pache  Government Ayurvedic Hospital  Room no.31,kayachikitsa department,Tuijapur road Dharashiv (osmanabad)
Osmanabad
MAHARASHTRA 		 9221296655

vinu2205@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE,R.A.Podar Medical college ,worli,mumbai.400018  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: vrundatriphaladi ghanvati, Reference: Yogratnakar uttraardha chapter prameha nidan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: -vrundatriphaladi ghanvati use as adjuvant therapy
2Comparator Arm (Non Ayurveda)-MetforminMedicine Name :Tab Metformin Dosage : 500mg BID (twice a day) Route: orally with food Total duration : 12 weeks
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patient having classical sign and symptoms of prameha.

BSL 126 to 250 mg or BSL PP gretar than 200mg to 300 or Hba1c gretar than 6.5 to 9 percentage or random BSL gretar than 200 mg  
 
ExclusionCriteria 
Details  Acute medical and surgical illness
IDMM diabetes ketoacidosis gestational diabetes drug induced diabetes
pregnant and lactating women
impaired renal function. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fasting BSL,Post prandial BSL,Hba1c and hs-crp(inflammatory parameter).  12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
on symptoms score of prameha at 12 weeks
on changes in lipid profile and BMI from baseline to 12 weeks in prameha. 		 12 weeks 
 
Target Sample Size   Total Sample Size="119"
Sample Size from India="119" 
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   N/A 
Date of First Enrollment (India)   30/11/2024 
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="4"
Months="2"
Days="7" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - 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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  from email of concern interested researcher

  6. For how long will this data be available start date provided 26-05-2022 and end date provided 26-03-2027?
    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   This study is a randomized open label controlled clinical study, to evaluate the efficacy of vrundatriphaladi ghanvati as adjuvant therapy  for 12 weeks in 119 patient with prameha (type 2 diabetes mellitus). The primary outcome will be F - BSL , PP-BSL, Hba1c and  hs-crp from base line to 12 weeks . secondary outcome will be on symptoms score of prameha at 12 weeks. 
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