CTRI

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CTRI Number

CTRI/2025/10/096569 [Registered on: 29/10/2025] Trial Registered Prospectively

Last Modified On:

28/10/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

To study effect of Ayurvedic formulations Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti in patients of Prameha - Type 2 Diabetes Mellitus.

Scientific Title of Study

An Open Randomized Controlled Clinical Trial to Evaluate the Efficacy of Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti 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	Dr Tejas Modhale
Designation	PG Scholar
Affiliation	Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College.
Address	OPD Kayachikitsa Department, Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. Institutional Area, Sector 4 Kharghar.Navi Mumbai Raigarh MAHARASHTRA 410210 India Raigarh MAHARASHTRA 410210 India
Phone	8421260434
Fax
Email	tejasmodhale16@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Minal S Vaidya
Designation	Professor and HOD
Affiliation	Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College.
Address	OPD Kayachikitsa Department, Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. Institutional Area, Sector 4 Kharghar.Navi Mumbai Raigarh MAHARASHTRA 410210 India Raigarh MAHARASHTRA 410210 India
Phone	9323790371
Fax
Email	drminalsvaidya@gmail.com

Details of Contact Person
Public Query

Name	Dr Minal S Vaidya
Designation	Professor and HOD
Affiliation	Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College.
Address	OPD Kayachikitsa Department, Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. Institutional Area, Sector 4 Kharghar.Navi Mumbai Raigarh MAHARASHTRA 410210 India Raigarh MAHARASHTRA 410210 India
Phone	9323790371
Fax
Email	drminalsvaidya@gmail.com

Source of Monetary or Material Support

Dr. G. D.Pol Foundation, YMT Ayurvedic Medical Collage. Institutional Area, Sector 4Kharghar. Navi Mumbai

Primary Sponsor

Name	Dr Tejas Modhale
Address	OPD Kayachikitsa Department, Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. Institutional Area, Sector 4 Kharghar.Navi Mumbai Raigarh MAHARASHTRA 410210 India
Type of Sponsor	Other [Self]

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 Tejas Modhale	Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College and Hospital	OPD Kayachikitsa Department, Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. Institutional Area, Sector 4 Kharghar.Navi Mumbai Raigarh MAHARASHTRA 410210 India Raigarh MAHARASHTRA	08421260434 tejasmodhale16@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Dr.G D Pol Foundation, YMT Ayurvedic medical college and charitable hospital	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

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm (Non Ayurveda)		-	Metformin	Route-oral, Dose-on stable dose prior 4 weeks,Dosage form-Tablet,Duration-90 Days.
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Vidangadi Lauha, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: Medicine will be used as combination therapy: Vidangadi Lauha with Metformin (2) Medicine Name: Vastyamayantaka Ghrita, Reference: Sahasrayogam, Route: Rectal, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Medicine will be used as combination therapy: Vastyamayantaka Ghrita Matra Basti and Vidangadi Lauha with Metformin. Basti will be administered 11 days in each month for consecutive 3 months

Inclusion Criteria

Age From	30.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	Fasting blood sugar more than 126 mg/dl and less than or equal to 250 mg/dl Postprandial blood sugar more than 140 mg/dl and less than or equal to 350 mg/dl HbA1c between 6.5 to 9.5 percentage Presence of 1 or more classical symptom of Prameha

ExclusionCriteria

Details

Type 1 Diabetes Mellitus or Gestational Diabetes
Patients on insulin or steroid therapy
History of ketoacidosis, diabetic coma, or severe infections
Major systemic illnesses
Immunocompromised patients or those on immunosuppressants
Severe hypertension i.e more than 180/100 mmHg

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To assess the symptomatic relief . To find out the effect of Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti on HbA1c	Assessment on 0th 30th 60th 90th day.

Secondary Outcome

Outcome	TimePoints
To evaluate the efficacy of Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti on Diabetic Nephropathy parameters eGFR, microalbumin-creatinine ratio, serum electrolytes.	Assessment on 0th 30th 60th 90th day.

Target Sample Size

Total Sample Size="99"
Sample Size from India="99"
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)

10/11/2025

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="1"
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 - NO

Brief Summary

The present study is an open randomized controlled clinical trial designed to evaluate the efficacy of Vidangadi Lauha alone and in combination with Vastyamayantaka Ghrita Matra Basti in Prameha (Type 2 Diabetes Mellitus). A total of 99 patients equally divided into three groups

Group A Metformin

Group B Metformin and Vidangadi Lauha

Group C Metformin and Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti

Each treatment will continue for 3 months, Basti will be given for 11 days in each month for 3 consecutive months, with follow-up at 0th, 30th, 60th, and 90th day. Assessment will be based on HbA1c, eGFR, lipid profile, microalbumin-creatinine ratio, and clinical symptoms. The study aims to assess changes in HbA1c, eGFR, and microalbumin-creatinine ratio to determine whether the Ayurvedic regimen offers superior glycemic and renal outcomes compared to Metformin alone.

Primary Hypothesis

Null Hypothesis H0 Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti are not more effective than Metformin in the management of Type 2 Diabetes Mellitus.

Alternate Hypothesis H1 Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti are more effective than Metformin in the management of Type 2 Diabetes Mellitus.