| CTRI Number |
CTRI/2026/03/106389 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Add on Effect of Vidangadi Churna Along with Metformin in
Prameha with Reference to Type- II Diabetes Mellitus |
|
Scientific Title of Study
|
Evaluation of Add on Effect of Vidangadi Churna Along with Metformin in
Prameha with Reference to Type II Diabetes Mellitus Randomized Controlled
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 |
VEDANT PANDURANG SHEJUL |
| Designation |
PG SCHOLAR (KAYACHIKITSA) |
| Affiliation |
PMTS AYURVED COLLEGE SHEVGAON |
| Address |
OPD No 113 Kaychikitsa Department PMTS AYURVED COLLEGE
AND SHRI EKNATH RUGNALAYA SHEVGAON AHILYANAGAR
Ahmadnagar
MAHARASHTRA
414502
India
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
8857922778 |
| Fax |
|
| Email |
shejulv78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SAMRAT SUNILRAO JADHAV |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PMTS AYURVED COLLEGE SHEVGAON |
| Address |
OPD No 113 Kaychikitsa Department PMTS AYURVED COLLEGE
AND SHRI EKNATH RUGNALAYA SHEVGAON AHILYANAGAR
Ahmadnagar
MAHARASHTRA
414502
India
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9975016828 |
| Fax |
|
| Email |
samratj125@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SAMRAT SUNILRAO JADHAV |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PMTS AYURVED COLLEGE SHEVGAON |
| Address |
OPD No 113 Kaychikitsa Department PMTS AYURVED COLLEGE
AND SHRI EKNATH RUGNALAYA SHEVGAON AHILYANAGAR
Ahmadnagar
MAHARASHTRA
414502
India
MAHARASHTRA
414502
India |
| Phone |
9975016828 |
| Fax |
|
| Email |
samratj125@gmail.com |
|
|
Source of Monetary or Material Support
|
| PMTs Ayurved College Shevgaon Akhegaon Road Shevgaon Dist.Ahilyanagar Maharashtra
India - 414502 |
|
|
Primary Sponsor
|
| Name |
VEDANT PANDURANG SHEJUL |
| Address |
PMTs Ayurved College Shevgaon Akhegaon Road Shevgaon Dist.Ahilyanagar Maharashtra India - 414502 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| VEDANT PANDURANG SHEJUL |
SHRI EKNATH AYURVED RUGNALAYA SHEVGAON |
OPD No 113 Kaychikitsa
Department PMTS AYURVED COLLEGE AND SHRI EKNATH RUGNALAYA SHEVGAON AHILYANAGAR
Ahmadnagar,MAHARASHTRA 414502
Ahmadnagar
MAHARASHTRA |
8857922778
shejulv78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PMT AYURVED COLLEGE SHEVGAON |
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: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadi churna , Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Metformin | 500mg OD |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed patient of type II DM having signs and symptoms
of Prameha.
2. Patient having their Fasting blood glucose level range of
120-200 mg/dl.
3. Post prandial blood glucose level range of 180-250 mg/dl.
4. Patient having HbA1c up to 6-8
5. Urine Sugar++
|
|
| ExclusionCriteria |
| Details |
1. K/C/O Pancreatic disorder.
2. Pregnant and lactating women.
3. Insulin-Dependent Diabetes Mellitus.
4. Patients with acute complications like K/C/O Hyperglycemic coma,
K/C/O ketoacidosis and infections like K/C/O gangrene.
5. Patients with K/C/O Nephropathy, K/C/O Neuropathy .
6. History of alcohol abuse.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Evaluate add on effect of vidangadi churna in management of prameha
with reference to Type II diabetes mellitus. |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To review Prameha according Ayurved and Modern.
2. To Review literature of Vidangadi Churna and metformin in detail.
3. To Evaluate Efficacy of metformin in prameha .
4. To compare efficacy of vidangadi churna + metformin and
metformin alone in prameha.
5. To observe any adverse drug reactions of vidangadi churna if any |
90 Days |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
01/04/2026 |
| 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="1"
Months="6"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
Prameha described in Ayurveda closely resembles Type-II Diabetes Mellitus, a chronic metabolic disorder characterized by persistent hyperglycemia due to insulin resistance and impaired insulin secretion. Metformin is a widely used first-line drug for the management of Type-II Diabetes Mellitus; however, many patients require additional therapy for better glycemic control. Vidangadi Churna, an Ayurvedic polyherbal formulation mentioned in classical texts for the management of Prameha, possesses properties that may help in regulating metabolism and reducing blood glucose levels. The present study is designed to evaluate the add-on effect of Vidangadi Churna along with Metformin in patients with Prameha with reference to Type-II Diabetes Mellitus. Participants will be randomly allocated into two groups: a control group receiving Metformin alone and a trial group receiving Metformin along with Vidangadi Churna for a specified treatment duration. The study aims to assess improvement in clinical symptoms and glycemic parameters to determine the efficacy of the combined therapy. |