| CTRI Number |
CTRI/2026/01/101134 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| 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
|
To Study The Efficacy Of Chandanadya Varti Anjana With Katakakhadiradi Kashaya In The Management Of Non Proliferative Diabetic
Retinopathy Timira |
|
Scientific Title of Study
|
An Open Label Double Arm Controlled Clinical Study On
The Efficacy Of Chandanadya Varti Anjana With Katakakhadiradi Kashaya In The Management Of Non Proliferative Diabetic
Retinopathy Timira |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renuka K Tavaragondi |
| Designation |
PG Scholar |
| Affiliation |
SDM Institute of Ayurveda Bangalore |
| Address |
Shalakya tantra Department
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,
Bengalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9513099805 |
| Fax |
|
| Email |
dhanutavaragondi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Stuvert |
| Designation |
Associate Professor |
| Affiliation |
SDM Institute of Ayurveda Bangalore |
| Address |
Shalakya tantra Department OPD-10,11,16 & 22.
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,
Bengalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9481028050 |
| Fax |
|
| Email |
stuvertdivya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Stuvert |
| Designation |
Associate Professor |
| Affiliation |
SDM Institute of Ayurveda Bangalore |
| Address |
Shalakya tantra Department OPD-10,11,16 & 22.
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,
Bengalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9481028050 |
| Fax |
|
| Email |
stuvertdivya@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Institute of Ayurveda Bangalore
Anchepalya Kumbalgodu post Banglore Mysore Highway 560074
Karnataka India |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital Bengaluru Shalakya tantra Department OPD 10 11 16 and 22
|
| Type of Sponsor |
Private 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 |
| Dr Renuka K Tavaragondi |
SDM Institute of Ayurveda Bangalore |
Shalakya tantra Department OPD-10,11,16 & 22.
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya 560074
Bengalore
Bangalore
KARNATAKA |
9513099805
dhanutavaragondi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRI DHARMASTHALA MANJUNATHESHWARA INSTITUTE OF AYURVEDA AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E133||Other specified diabetes mellituswith ophthalmic complications. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chandanadya Varti, Reference: Chakradatta, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 40(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritakyadi Varti, Reference: Bhaisajya Ratnavali, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 40(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with signs and symptoms Non Proliferative Diabetic Retinopathy mild to
moderate Timira
Best corrected ETDRS VA in study eye with Log MAR 0.1 t o 0.7 and Snellens near vision
chart from N8 N24
Patients with good glycaemic control less than 9 percent |
|
| ExclusionCriteria |
| Details |
Patients with proliferative diabetic retinopathy.
Known case o f Glaucoma, Cataract and Gestational diabetes.
Patients with complicating severe vitreous haemorrhage, or requiring laser and vitrectomy
treatment.
Patients who have received retina laser photocoagulation.
Patients with any retinal surgeries. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement i n the subjective parameters like blurred vision and floaters |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in fundoscopic changes such as decrease in number o f microaneurysms intra
retinal dates observed through Fundoscopy direct & indirect & Fundus photography and
marked in the quadrant chart from the base score |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
02/02/2026 |
| 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
|
Netra is considered as Pradhana Indriya in Ayurveda and vision plays a crucial role in daily life. Timira is described as a Drishtigata Roga characterized by gradual diminution of vision which may lead to blindness. The severity of visual impairment depends on the involvement of Patala and Dosha Sthanasamshraya. Diabetes mellitus is a common non communicable disease and diabetic retinopathy is one of its major microvascular complications and a leading cause of vision loss worldwide. The risk of diabetic retinopathy increases with the duration of diabetes especially after puberty Though classical texts do not directly mention Timira as an Upadrava of Prameha in Brihatrayis it is indicated that vital organs including the eye are involved in Prameha Samprapti. Prameha and Timira share common etiological factors such as Guru Snigdha Vidahi Ahara and Divaswapna leading to increased Kleda and Abhishyanda of Rupavaha Srotas resulting in Timira. Hence diabetic retinopathy can be understood in Ayurveda as Timira associated with Prameha Modern treatment options like anti VEGF therapy laser photocoagulation and vitrectomy are effective but costly. Ayurveda offers cost effective treatment options through Kriya Kalpa procedures. Anjana Chikitsa is described to improve clarity of vision and has shown beneficial effects in diabetic retinopathy Therefore the present study is undertaken to evaluate the effect of Chandanadya Varti Anjana in patients with Non Proliferative Diabetic Retinopathy with Katakakhadiradi Kashaya given as a common intervention in both groups |