| CTRI Number |
CTRI/2026/03/106260 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| 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
|
Efficacy of Ayurvedic medicine - kwath in Diabetic Retinopathy. |
|
Scientific Title of Study
|
Effect of Vasadi Kwath in the Management of Timir W.S.R to Diabetic Retinopathy- A Clinical Study. |
| 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 Shubhangi Lohakare |
| Designation |
Ph.D Scholar |
| Affiliation |
|
| Address |
Government Ayurved College, Raje Raghuji Nagar,Nagpur
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9890698452 |
| Fax |
|
| Email |
shindeshubh84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hari Umale |
| Designation |
Professor |
| Affiliation |
Government Ayurved College, Nagpur |
| Address |
Department of Shalakya Tantra,Government Ayurved College, Raje Raghuji Nagar,Nagpur
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9423682026 |
| Fax |
|
| Email |
hariumale58@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Lohakare |
| Designation |
Ph.D Scholar |
| Affiliation |
g |
| Address |
Government Ayurved college, Raje Raghuji Nagar, Nagpur
Nagpur
MAHARASHTRA
440009
India |
| Phone |
09890698452 |
| Fax |
|
| Email |
shindeshubh84@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College, Nagpur |
|
|
Primary Sponsor
|
| Name |
Goverment Ayurved Colllege Nagpur |
| Address |
Department Of Shalakya Tantra, Raje Raghuji Nagar,Govt Ayurved College, Nagpur |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrShubhangi Lohakare |
Goverment Ayurved College, Nagpur |
Shalakya Tantra OPD, Goverment Ayurved College, Raje Raghuji Nagar, Nagpur
Nagpur
MAHARASHTRA |
09890698452
shindeshubh84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, goverment ayurved college, nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H350||Background retinopathy and retinalvascular changes. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | antioxidant capsules | antioxidant capsules OD for 3 months | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: vasadi kwath, Reference: sharangdhar samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Inclusive criteria-
Patients suffering from type II D.M. of age group 30 to 70 yrs. having clinical features of diabetic retinopathy seen on fundus examination will be selected for study.
|
|
| ExclusionCriteria |
| Details |
Exclusive criteria-
Type I D.M. patients.
Age below 30 yrs & above 70 yrs.
Hypertensive patients.(uncontrolled)
Uveitis, Glaucoma, Cataract.
Systemic infections.
Trauma, Inflammatory & neoplastic conditions of eye.
ARMD, CRVO, CRAO, RD, RP, VH.
Optic atrophy.
Inj. Avastin given patients.
Photocoagulation done patients.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fundus changes of background diabetic retinopathy. Changes in clinical symptoms like vision etc |
at baseline and after 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| symptoms getting releieved , changes in fundus after treatment |
at baseline & after 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
25/03/2026 |
| 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="0"
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 clinical study aims to evaluate the efficacy of Vasadi kwath (ayurvedic medicine) in the management of Timir w.s.r to Diabetic Retinopathy (NPDR) in reducing fundus changes of background diabetic retinopathy and other associated symptoms..Eligible participants will be randomly allocated to receive the intervention for 3 months with assesment of grades at baseline and after 3 months of intervention. This trial is designed as a single center, prospective clinical study conducted in Shalakya Tantra OPD of Government Ayurved College, Nagpur, India. |