| CTRI Number |
CTRI/2025/08/093759 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of Thazhy with Manjishta Ksheera Kalka against Anjana with Elaneer kuzhambu in improving Vision in participants having Mild to Moderate Non - proliferative Diabetic Retinopathy |
|
Scientific Title of Study
|
The Efficacy of Thazhy with Manjishta Kseera Kalka, against Anjana with Elaneer kuzhambu in improving Visual Acuity in Mild to Moderate 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 Adithya Babu P T P |
| Designation |
Professor |
| Affiliation |
V P S V Ayurveda College Kottakkal |
| Address |
Department Of Shalakya Tantra
V P S V Ayurveda College
Kottakkal
Edarikode P O
Malappuram District
Malappuram
KERALA
676501
India |
| Phone |
9446228869 |
| Fax |
|
| Email |
adithdr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreeja Sukesan |
| Designation |
Professor and Head |
| Affiliation |
Government Ayurveda College Thripunithura |
| Address |
Department Of Shalakya Tantra
Government Ayurveda College
Thripunithura
Puthiyakavu P O
Ernakulam
KERALA
682301
India |
| Phone |
7034115701 |
| Fax |
|
| Email |
doctorsreejamd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeena N J |
| Designation |
Professor and Head |
| Affiliation |
V P S V Ayurveda College Kottakkal |
| Address |
Department Of Shalakya Tantra
V P S V Ayurveda College
Kottakkal
Edarikode P O
Malappuram District
Malappuram
KERALA
676501
India |
| Phone |
9495974927 |
| Fax |
|
| Email |
drjeenanj@gmail.com |
|
|
Source of Monetary or Material Support
|
| V P S V Ayurveda College Kottakkal malappuram District Kerala India PIN 676501 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Professor
Department of Shalakya tantra
Edarikode P O
Malappuram District
Kerala |
| Type of Sponsor |
Other [Dr Adithya Babu P T P, professor, VPSV Ayurveda college, Kottakkal] |
|
|
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 Adithya Babu P T P |
V P S V Ayurveda College Kottakkal |
OPD Department of Shalakya Tantra - Nethra room no A207
Kottakkal
Edarikode P O
malappuram District
Malappuram
KERALA |
9446228869
adithdr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) Vaidyaratnam P S Varier Ayurveda College Kottakkal |
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 | Procedure | - | Anjana | (Procedure Reference: , Procedure details: one drop of Elaneer kuzhambu in each eye once daily)
| | 2 | Intervention Arm | Procedure | - | Thazhy | (Procedure Reference: , Procedure details: 20 grams of manjishta root powder is mixed with sufficient quantity of cows milk to get a fine paste & this paste is applied over a piece of fine cotton cloth & placed over the closed eyes for a period of 20 minutes once a day.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ophthalmoscopically assesses mild to moderate non proliferative diabetic retinopathy of any duration
participants with visual acuity 6/12 to 6/60
|
|
| ExclusionCriteria |
| Details |
Severe NPDR (4– 2 –1 rule)
Participants with visual acuity less than 6/60
Participants having cataract
Participants having severe macular oedema (CMT more than 400 micrometre)
Subjects with poorly controlled diabetes mellitus (HbA1c more than 10%)
Those who are unable to follow the treatment regime.
Contra indications for either treatment procedure
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Examination of Visual acuity by Logmar chart
Ophthalmoscpy
fundus photography
OCT macula
|
0th day, 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of vision related quality of life assessment using National eye Institute Visual function questionnaire -25(VFQ-25) |
0th day, 30 th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="2"
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
|
A randomized controlled trial to assess the efficacy of Thazhy with Manjishta Ksheera kalka against Anjana With Elaneer kuzhambu in Mild to Moderate Non Proliferative Diabetic Retinopathy. It is a non inferiority trial. 2 groups with 50 participants in each trial(Thazhy) and control(Anjana). The outcome will be assessed by the examination of visual acuity using Logmar chart, OCT macula and Fundus examuination. on 0th and 30th day. Follow up on 60th and 90th days. |