| CTRI Number |
CTRI/2025/05/087774 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of dhatryadi rasakriyanjana(collyrium) with nisha triphala yoga(decoction) and katakadi anjana(collyrium) with nisha triphala yoga(decoction)in the management of non proliferative diabetic retinopathy |
|
Scientific Title of Study
|
An Open Label Double Arm Comparative Clinical Study To Evaluate The Efficacy Of Dhatryadi Rasakriya Anjana With Nisha Triphala Yoga And Katakadi Anjana With Nisha Triphala Yoga In The Management Of Non Proliferative Diabetic Retinopathy |
| 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 Sukanya K |
| Designation |
PG Scholar |
| Affiliation |
Sri Kalabyraveswaraswamy Ayurvedic Medical College Hospital and Research centre |
| Address |
Room no 21
Dept of Shalaka tantra
Sri Kalabyraveswaraswamy Ayurvedic Medical College Hospital and Research centre
No 10 Pipeline road RPC Layout
Vijayanagar 2nd stage Bangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
8156968253 |
| Fax |
|
| Email |
sukanyak1309@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUJATHAMMA K |
| Designation |
Professor |
| Affiliation |
Sri Kalabyraveswaraswamy Ayurvedic Medical College Hospital and Research centre |
| Address |
Room no 23
Dept of Shalaka tantra
Sri Kalabyraveswaraswamy Ayurvedic Medical College Hospital and Research centre
No 10 Pipeline road RPC Layout
Vijayanagar 2nd stage Bangalore Karnataka
Bangalore
KARNATAKA
560104
India |
| Phone |
9448848786 |
| Fax |
|
| Email |
drsujathammaskamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUJATHAMMA K |
| Designation |
Professor |
| Affiliation |
Sri Kalabyraveswaraswamy Ayurvedic Medical College Hospital and Research centre |
| Address |
Room no 23
Dept of Shalaka tantra
Sri Kalabyraveswaraswamy Ayurvedic Medical College Hospital and Research centre
No 10 Pipeline road RPC Layout
Vijayanagar 2nd stage Bangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
9448848786 |
| Fax |
|
| Email |
drsujathammaskamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sukanya K Room No 21 Department Of Pg Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore 560104 |
|
|
Primary Sponsor
|
| Name |
DR SUAKNYA K |
| Address |
Sri Kalabyraveswaraswamy Ayurvedic Medical College Hospital and Research centre |
| 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 |
| DR KIRAN M GOUD |
Sri Kalabyraveswara swamy Ayurvedic Medical college hospital and research centre |
Sri Kalabyraveswaraswamy Ayurvedic Medical College Hospital and Research centre
No 10 Pipeline road RPC Layout Vijayanagar 2nd stage
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCHRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E113||Type 2 diabetes mellitus with ophthalmic complications. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | a~jjanam, अंजनम् | (Procedure Reference: Susrutha Samhitha, Procedure details: Applied In Lower Eyelids From Inner Canthus To Outer Canthus Once Daily In The Morning For 48 Days)
(1) Medicine Name: Dhatryadi Rasakriya Anjana, Reference: Chakradutta, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 350(mg), Frequency: od, Duration: 48 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nisha Triphala Hima Kashaya, Reference: Yogaratnakara, Route: Oral, Dosage Form: Sheeta/ Hima, Dose: 96(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 48 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nisha Triphala Hima Kashaya, Reference: Yogaratnakara, Route: Oral, Dosage Form: Sheeta/ Hima, Dose: 96(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 48 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: | | 4 | Comparator Arm | Procedure | - | a~jjanam, अंजनम् | (Procedure Reference: Susrutha Samhitha, Procedure details: Applied In Lower Eyelids From Inner Canthus To Outer Canthus Once Daily In The Morning For 48 Days)
(1) Medicine Name: Katakadi Anjana , Reference: Sarangadhara Samhitha, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 200(mg), Frequency: od, Duration: 48 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with signs and symptoms of non proliferative diabetic retinopathy
patients with history of type 1 and type 2 diabetic retinopathy
patient with good glycemic control
patients with blurred vision with a minimal visual acuity of 6by24 |
|
| ExclusionCriteria |
| Details |
Patients with other retinal changes with Proliferative Diabetic retinopathy hypertensive retinopathy retinopathy of blood dycrasias retinopathy of prematurity will be excluded
Patients with a history of visual impairments like glaucoma matured lenticular opacities will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess The Visual Acuity And The Presence Or Absence Of Floaters To Assess The Reduction In Microaneurysm Intra Retinal Haemorrhages Intra Retinal Microvascular Abnormality |
48 days Of Intervention With Follow Up For 1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 |
|
Date of First Enrollment (India)
|
16/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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 current study aims at evaluating the effect of Dhatryadi rasakriyanjana with Nishatriphala yoga and Katakadi Anjana with Nishatriphala yoga in the management of Diabetic retinopathy and comparing the effects of both groups.Dhatryadi rasakriyanjana has been mentioned in Timira chikitsa and the ingredients have pramehahara and chakshushya properties.Katakadi anjana has netraprasadana and chakshushya properties and katakaphala is said to be mehahara and vranasothahara.In both groups Nishatripahala yoga mentioned in Prameha chikitsadhikara is given internally as Hima kashaya.Thus the current study endeavours to create a treatment approach that is safer, non-invasive, capable of addressing the root cause, and can also effectively slow down the progression of the disease. |