| CTRI Number |
CTRI/2025/11/097830 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Ayurvedic clinical study to access the efficacy of Nayanasukha Varti Anjana on Dwitiya Patalagata Timira (Senile immature cataract) |
|
Scientific Title of Study
|
Clinical Study to evaluate the effect of Nayana sukha Varti Anjana in the management of Dvitiya Patalagata Timira(senile immature cataract) |
| 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 Anusha Patil |
| Designation |
PG Scholar |
| Affiliation |
Alva’s Ayurveda Medical College and Hospital |
| Address |
Dept of P.G. studies in Shalakya Tantra, Alvas Ayurveda Medical College, Moodubidire, D.K. District, Karnataka - 574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9686662101 |
| Fax |
|
| Email |
anuanandpatil345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemachandra Shetty |
| Designation |
Associate Professor |
| Affiliation |
Alva’s Ayurveda Medical College and Hospital |
| Address |
Dept of P.G. studies in Shalakya Tantra, Alvas Ayurveda Medical College, Moodubidire, D.K. District, Karnataka - 574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9632954243 |
| Fax |
|
| Email |
drhemachandra1985@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemachandra Shetty |
| Designation |
Associate Professor |
| Affiliation |
Alva’s Ayurveda Medical College and Hospital |
| Address |
Dept of P.G. studies in Shalakya Tantra, Alvas Ayurveda Medical College, Moodubidire, D.K. District, Karnataka - 574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9632954243 |
| Fax |
|
| Email |
drhemachandra1985@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College, Moodubidire, D.K.District, Karnataka -574227 |
|
|
Primary Sponsor
|
| Name |
Dr Anusha Patil |
| Address |
Dept of P.G.studies in Shalakya Tantra, Alvas Ayurveda Medical College, Moodubidire, D.K.District, Karnataka -574227 |
| 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 Anusha |
Alvas Ayurveda Medical College and Hospital |
Shalakya Tantra OPD
Alvas Ayurveda Medical College and Hospital, Moodubidire, Dakshina Kannada, Karnataka
Dakshina Kannada
KARNATAKA |
9686662101
anuanandpatil345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Alvas Ayurveda Medical College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H258||Other age-related cataract. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nayanasukha Varti Anjana , Reference: Bhaishajya Ratnavali 64th chapter and Cakradatta 59th chapter, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 50(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: Varti is applied to both the eyes as collyrium in the morning for 60days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with visual acuity 6/9 to 6/36
Patients with lakshanas of Dwitiya Patalagata Timira
Patients with senile immature cataract
Vihwal Drusti - blurred vision
Abhumanapi Pashyati - visualization of non existing things like dots, threads or hair
glare
Diplopia / Polyopia |
|
| ExclusionCriteria |
| Details |
Patients with senile mature cataract
Visual acuity less than 6/60
Congenital, traumatic, developmental, toxic, metabolic, complicated, radiational cataract
Patients under steroid treatment or any kind of immunosuppressive therapy or any cataract inducing medications
Patients associated with any inflammatory and infective ocular conditions
Anjana Anahara |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced blurred vision or improvement in the vision |
Before treatment
30 th day
60 th day
90 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduced glare, diplopia or polyopia, visualization of non existing things like dots, threads or hair |
before treatment
30 th day
60 th day
90 th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
09/12/2025 |
| 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="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
|
Timira is explained under Drustigata Netra Rogas, if proper care is not taken Timira progresses to Kacha and further leads to Linganasha. Timira has lakshanas likeDrustibramsha, Vihwaldrusti, Makshika Mashaka Keshajaala Pashyaati, Suchi Pamsha na pashyati which can be correlated to senile immature cataract. Senile cataract is also known as age related cataract and is the most common form of acquired cataract, which is one of the main cause for blindness. The symptoms include glare, diplopia, blackspots,coloured halos and blurring of vision. The conventional system of medicine has no non-surgical measures to delay, prevent or reverse the development of senile cataract. In our classics the line of treatment like Kayashodhana followed by Kriyakalpas like Tarpana, Anjana and Nasya have been mentioned which may help in delaying the progression of cataract. In Bhaishajya Ratnavali and Cakradatta, Nayanasukha Varti Anjana is indicated in Timira. So here is any Ayurvedic approach to delay the progression of senile cataract.
HYPOTHESIS - H0 - There is no statistically significant effect of Nayanasukha Varti Anjana in Dwitiya Patalagata Timira (Senile immature cataract) H1 - There is statistically significant effect of Nayanasukha Varti Anjana in Dwitiya Patalagata Timira (Senile immature cataract)
Study design - Open label single arm clinical study Total duration -90days Clinical trials will be performed on group of 40patients at Department of Shalakya Tantra OPD and IPD of Alvas Ayurveda Medical College and Hospital
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