| CTRI Number |
CTRI/2025/04/085111 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A placebo controlled clinical study to study effectiveness of Sahadevi Eye drop in Timira(Immature cataract) |
|
Scientific Title of Study
|
A prospective randomized placebo-controlled clinical study to evaluate the therapeutic effect of Sahadevi (Cyanthillium cinerarium (L.) H. Rob) eye drops in Timira with special reference to 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 |
Anjana S Gokul |
| Designation |
Post Graduate Scholar |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
PG Scholar, Dept of Shalakya Tantra, Parul Institute of Ayurved and Research, Parul University, Ishwarapura, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9447713071 |
| Fax |
|
| Email |
anjanasgokul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh Tejasvi S |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Associate Professor,Dept of Shalakya Tantra, Parul Institute of Ayurved and Research, Parul University, Ishwarapura, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9164774710 |
| Fax |
|
| Email |
ganeshtejasvi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ganesh Tejasvi S |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Associate Professor,Dept of Shalakya Tantra, Parul Institute of Ayurved and Research, Parul University, Ishwarapura, Vadodara, Gujarat
GUJARAT
391760
India |
| Phone |
9164774710 |
| Fax |
|
| Email |
ganeshtejasvi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Anjana S Gokul, PG Scholar, Dept of Shalakya Tantra, Parul Institute of Ayurved and Research, Parul University ,P.O. Limda, Waghodia - 391760, Vadodara, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Dr Anjana S Gokul |
| Address |
PG Scholar, Dept of Shalakya Tantra, Parul Institute of Ayurved and Research, Parul University, P.O. Limda, Waghodia - 391760, Vadodara, Gujarat, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anjana S Gokul |
Khemdas Hospital, Parul Institute of Ayurved and Research, Parul University |
OPD no 4,Khemdas Hospital, Parul Institute of Ayurved and Research, Parul University,Ishwarpura,Waghodia,Vadodara
Vadodara
GUJARAT |
9447713071
anjanasgokul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIAR-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H259||Unspecified age-related cataract. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Sahadevi Eye Drops, Reference: NA, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo Eye Drops | (1) Medicine Name: Placebo Eye Drops, Reference: NA, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having immature cataract |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from inflammatory and infective disease of eyeball
and its appendages.
2. Patients who are suffering from congenital cataract, mature and hyper
mature cataract, traumatic cataract.
3. Any systemic disease and/or medication that interferes with the intervention of current study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in visual acuity (distance and near) assessed by Snellen’s and Jaeger’s charts |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Reduction in symptoms such as glare, diplopia, and floaters based on patient-reported outcomes.
|
45 days |
2.Change in cataract grade assessed by slit lamp examination and LOCS III classification.
|
45 days |
| 3.Assessment of safety and tolerability through adverse drug reaction monitoring |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/06/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anjanasgokul@gmail.com].
- For how long will this data be available start date provided 07-09-2026 and end date provided 07-09-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Cataract is the most important cause of avoidable blindness affecting 12 to 15 million persons worldwide. Till date an effective non-invasive therapy for immature cataract has not been found. The only treatment of choice is surgery. Owing to the increased incidence rate of immature cataract and possible complications and contraindications of surgery,research for the need for drugs that could effectively tackle the problem has arisen. This present clinical study aims at assessing the effectiveness of Sahadevi eye drops in comparison to placebo on immature cataract. |