| CTRI Number |
CTRI/2025/07/092025 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative clinical study of Two Ayurvedic Formulations in Managing Early Signs of Pre-Diabetes |
|
Scientific Title of Study
|
Randomized Comparative Clinical Study to Evaluate Efficacy Of Udak Mehadi Ghan Vati With Eladi Ghan Vati in Prameh Purvarupa With Special Reference to Pre Diabetes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TUSHAR SURESH PUNSE |
| Designation |
Associate Professor |
| Affiliation |
Aarihant Ayurvedic Medical College and Research Institute |
| Address |
department of Kayachikitsa, Aarihant Ayurvedic Medical College and Research Institute Gandhinagar
department of Kayachikitsa, Aarihant Ayurvedic Medical College and Research Institute Gandhinagar
Gandhinagar
GUJARAT
382422
India |
| Phone |
8788833277 |
| Fax |
|
| Email |
tusharpunse4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
TUSHAR SURESH PUNSE |
| Designation |
Associate Professor |
| Affiliation |
Aarihant Ayurvedic Medical College and Research Institute |
| Address |
department of Kayachikitsa, Aarihant Ayurvedic Medical College and Research Institute Gandhinagar
department of Kayachikitsa, Aarihant Ayurvedic Medical College and Research Institute Gandhinagar
GUJARAT
382422
India |
| Phone |
8788833277 |
| Fax |
|
| Email |
tusharpunse4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
TUSHAR SURESH PUNSE |
| Designation |
Associate Professor |
| Affiliation |
Aarihant Ayurvedic Medical College and Research Institute |
| Address |
department of Kayachikitsa, Aarihant Ayurvedic Medical College and Research Institute Gandhinagar
department of Kayachikitsa, Aarihant Ayurvedic Medical College and Research Institute Gandhinagar
Gandhinagar
GUJARAT
382422
India |
| Phone |
8788833277 |
| Fax |
|
| Email |
tusharpunse4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarihant Ayurved Hospital, Teaching Hospital of Aarihant Ayurvedic Medical College and Research Institute, At Bhoyan Rathod Villege, Near ONHC WSS, Opp. IFFCO Ahemadabad Kalol Gujrat India 382420 |
|
|
Primary Sponsor
|
| Name |
Dr Tushar Suesh Punse |
| Address |
department of Kayachikitsa, Aarihant Ayurvedic Medical College and Research Institute,At Bhoyan Rathod Villege, Near ONHC WSS, Opp. IFFCO Ahemadabad Kalol Gujrat India 382420 |
| Type of Sponsor |
Other [self finance ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR TUSHAR SURESH PUNSE |
Aarihant Ayurveda Hospital, Aarihant Ayurvedic Medical College and Research Institute. |
Department of Kayachikitsa, Second Floor, Ayush Building, At Bhoyan Rathod Village Highway near ONGC WSS opp IFCCO Ahmedabad Kalol Gujarat 382422
Gandhinagar
GUJARAT |
08788833277
tusharpunse4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee RA Poddar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Eladi Ghan Vati, Reference: Bhaishajya ratnavali prameha roga adhikara 37/27, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Udak Mehadi Ghan Vati, Reference: Bhaishajya ratnavali prameha roga adhikara 37/21, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 30 to 65yrs of both sexes
Subject who are willing to give written informed consent
Plasma glucose level Fasting 100 to 125 mg per dl
Postprandial 140 to 199 mg per dl
HB1AC greater than 6.4 per hundred ml
Not known case of Diabetes Mallitus
Presence of prameha purvaroopa as described in diagnostic criteria |
|
| ExclusionCriteria |
| Details |
Patient diagnosed with diabetes or having diabetes complications.
Patient suffering from bleeding disorder sleep disorders gum diseases H.pylori infections
chronic inflammation anemia.10
Patient suffering from pancreatitis lumbar spondylitis AIDS HEPATITIS and TB. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kara-pada suptata
Kara-pada daha
Madhurasyata
Pipasa
Sweda
Alasya
Nidra
Angasada
Angagandha
Shwasa
FBS
PPBS
HbA1c |
0 , 30, 60 and 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FBS, PPBS , HB1AC |
after 30 days after 60 days after 90 days |
|
|
Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
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)
|
11/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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 - NO
|
|
Brief Summary
|
Study Purpose The purpose of this study is to evaluate and compare the efficacy of Udak Mehadi Ghan Vati and Eladi Ghan Vatiin managing Prameh Purva Rupa .The goal is to examine whether early intervention with Ayurvedic medicines can reduce or prevent the progression to diabetes mellitus
Condition Disease Ayurvedic Diagnosis Prameh Purva Rupa prodromal stage of Prameha
Modern Correlation Prediabetes based on Fasting Blood Sugar 100 to 125 mg per dL Postprandial Blood Sugar 140 to 199 mg per dL and HbA1c 5.7 to 6.4 per dl
Interventions Group A Trial Group Udak Mehadi Ghan Vati Dose 250 mg orally twice daily Anupana Lukewarm water Study Duration 90 days
Group B Control Group Eladi Ghan Vati Dose 250 mg orally twice daily Anupana Lukewarm water Study Duration 90 days
Study Design Type Randomized openlabel double arm comparative clinical trial
Duration 24 months including recruitment treatment and analysis
Randomization Block randomization
Sample Size 146 participants 73 in each group
Assessment Parameters Subjective symptoms of Prameh Purva Rupa and objective markers including Fasting Blood Sugar FBS Postprandial Blood Sugar PPBS and HbA1c
Population Adults aged 30 to 65 years
Diagnosed with prediabetes as per ADA WHO criteria
Exhibiting 5 classical symptoms of Prameh Purva Rupa eg numbness or burning in hands and feet excessive thirst sweet taste in mouth heaviness etc
Recruited from the OPD and IPD of Ayurved Hospital attached to an Aarihant Ayurvedic Medical College and Research Institute
Expected Outcome The study aims to determine whether Udak Mehadi Ghan Vati provides superior clinical benefits over Eladi Ghan Vati in managing prediabetic conditions Expected outcomes include reduction in subjective symptoms of Prameh Purva Rupa and improvement in FBS PPBS and HbA1c values potentially preventing progression to full blown diabetes mellitus |