| CTRI Number |
CTRI/2025/05/087058 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
USE OF DADIMADYA GHRUT IN KIDNEY FAILURE |
|
Scientific Title of Study
|
EVALUATION OF EFFECT OF GOKSHURADI GUGGUL AND DADIMADYA GHRIT MATRA BASTI IN MANAGEMENT OF DIABETIC NEPHROPATHY IN COMPARISON WITH STANDARD PROTOCOL-RANDOMIZED CONTROL CLINICAL 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 |
DR ONKAR ANKUSHRAO KANDE |
| Designation |
PG-SCHOLAR |
| Affiliation |
Dr.G.D.Pol Foundations Ayurvedic Medical College, Sector 4 Kharghar, Navi Mumbai |
| Address |
OPD NO 8 , KAYACHIKITSA DEPARTMENT , G.D. POL FOUNDATION , Y.M.T. AYURVEDIC MEDICAL COLLEGE , INSTITUTIONAL AREA , SECTOR 4 KHARGHAR , NAVI MUMBAI
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8888989594 |
| Fax |
|
| Email |
kandedronkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Minal S Vaidya |
| Designation |
Professor And HOD |
| Affiliation |
Dr.G.D.Pol Foundations Ayurvedic Medical College, Sector 4 Kharghar, Navi Mumbai |
| Address |
OPD NO 8 , KAYACHIKITSA DEPARTMENT , G.D. POL FOUNDATION , Y.M.T. AYURVEDIC MEDICAL COLLEGE , INSTITUTIONAL AREA , SECTOR 4 KHARGHAR , NAVI MUMBAI
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9323790371 |
| Fax |
|
| Email |
drminalsvaidya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ONKAR ANKUSHRAO KANDE |
| Designation |
PG-SCHOLAR |
| Affiliation |
Dr.G.D.Pol Foundations Ayurvedic Medical College, Sector 4 Kharghar, Navi Mumbai |
| Address |
OPD NO 8 , KAYACHIKITSA DEPARTMENT , G.D. POL FOUNDATION , Y.M.T. AYURVEDIC MEDICAL COLLEGE , INSTITUTIONAL AREA , SECTOR 4 KHARGHAR , NAVI MUMBAI
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8888989594 |
| Fax |
|
| Email |
kandedronkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| G.D. POL FOUNDATION YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL SECTOR 4, KHARGHAR, NAVI MUMBAI. MAHARASHTRA. INDIA. 410210 |
|
|
Primary Sponsor
|
| Name |
Dr.Onkar Ankushrao Kande |
| Address |
opd no. 8 kayachikitsa department ,ymt ayurvedic medical college, g d pol foundation kharghar navi mumbai |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| DrOnkar Ankushrao Kande |
YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL |
KAYACHIKTSA OPD NO.8 G.D.POL FOUNDATION YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL SECTOR 4 KHARGHAR, NAVI MUMBAI 410210
Raigarh
MAHARASHTRA |
8888989594
kandedronkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E112||Type 2 diabetes mellitus with kidney complications. Ayurveda Condition: E1121, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: GOKSHURADI GUGGUL, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Guggulu , Dose: 125(mg), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: bhavprakash, Procedure details: In dakshinpaduthhan shayan asana the patient will be given Basti via Basti yantra.)
(1) Medicine Name: Dadimadya ghrit basti, Reference: bhavprakash, Route: Rectal, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Duration: 9 Days | | 3 | Comparator Arm (Non Ayurveda) | | - | STRANDARD PROTOCOL | OHA DRUGS,ANTIHYPERTENSIVE DRUGS, STATINS |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
AC Ratio ( 30- 300 mg/g)
|
|
| ExclusionCriteria |
| Details |
Age below 18 yrs and above 80 yrs.
Acute life threatening condition.
Immuno compromised patients.
Type I Diabetes
Pregnancy and lactating female |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of the efficacy of Gokshuradi guggulu and
Dadimadya ghrita
Matra
basti
basti is effective in management of Diabetic Nephropathy . |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the effect of Gokshuradi guggulu &
Dadimadya
ghrut
special reference to albumin creatinine ratio. (SACR)
2: Study the probable mode of action of Gokshuradi guggulu a
Matra
basti
Dadimadya
Matra
basti in management of Diabetic Nephropathy
3: Subjective parameters
ghrut |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
20/05/2025 |
| 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 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
|
Summary of Research Study Study Title An open Randomized controlled clinical trial of Gokshuradi guggulu and Dadimadya ghrut Matra basti in Diabetic Nephropathy.
Objective To assess the efficacy of Gokshuradi guggulu and Dadimadya ghrut Matra basti in managing Diabetic Nephropathy compared to standard care.
Methodology The study will include patients with Diabetic Nephropathy (Grade 2 Kidney Disease) and albumin creatinine ratio (ACR) >30 mg/dl. Patients will be randomly assigned to receive either Gokshuradi guggulu and Dadimadya ghrut Matra basti or standard care.
Outcome Measures The study will evaluate the efficacy of the treatment using objective criteria such as:
1. Albumin creatinine ratio (ACR) 2. eGFR value 3. Urine routine and microscopic 4. HBA1C value
Expected Outcome The study aims to determine if Gokshuradi guggulu and Dadimadya ghrut Matra basti is more effective in managing Diabetic Nephropathy than standard care. |