| CTRI Number |
CTRI/2025/02/080003 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| 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
|
A clinical trial to study Ushiradi Taila Nasal Drops in early Cataract |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study Of Ushiradi Siddha Taila Pratimarsha Nasya In 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 Prajkta Mal |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University) |
| Address |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved & Hospital, Department of Shalakyatantra,OPD No.-24, Katraj, Dhankawadi , Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9172492822 |
| Fax |
|
| Email |
prajkta.mal-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Mulik |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University) |
| Address |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved & Hospital Department of Shalakyatantra,OPD No.-24 Katraj, Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9175382645 |
| Fax |
|
| Email |
sarita.mulik@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarita Mulik |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University) |
| Address |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved & Hospital Department of Shalakyatantra,OPD No.-24 Katraj, Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9175382645 |
| Fax |
|
| Email |
sarita.mulik@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Department of Shalakya Tantra, College of Ayurved and Hospital,Bharati Vidyapeeth (Deemed to be University) Katraj Dhankawadi Campus,Pune 411043 |
|
|
Primary Sponsor
|
| Name |
Dr Prajkta Mal |
| Address |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved & Hospital, Department of Shalakyatantra OPD no-24, Katraj , Dhankawadi, Pune |
| 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 Prajkta Mal |
Bharati Ayurved Hospital |
Bharati Vidyapeeth(Deemed to be University), College of Ayurved & Hospital, Department of Shalakyatantra,OPD No.-24 Katraj, Dhankawadi , Pune
Pune
MAHARASHTRA |
9172492822
prajkta.mal-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE [BV(DU)COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H250||Age-related incipient cataract. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Catagon eye drop | Topical installation of catagon eye drop twice a day in an affected eye for 4 months | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ushiradi Siddha tail, Reference: Sushrut samhita, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Participants of both gender (males and female) who are having immature cataract and aged between 40 – 80 years included in this study.
Participants having visual acuity 6/36 or more. |
|
| ExclusionCriteria |
| Details |
Participants having vision less than 6/36
History of systemic diseases except Diabetes and Hypertension.
Participants having Glaucoma , corneal ulcer , dacryocystitis or any type of ocular surface or retinal pathology will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of visual acuity based on LOGMAR chart. |
120 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the symptoms of blurring of vision ,visualization of non existing
things like dots,threads,etc; difficulty in day vision,glare; difficulty in night vision or dim light. |
120 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
14/02/2025 |
| 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
|
This study is a randomized controlled, open label, parallel group study on efficacy of Ushiradi Siddha taila Pratimarsha nasya in senile immature cataract daily for 4 months in 30 patients with senile immature cataract that will be conducted in Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital, Department of Shalakya Tantra, OPD number 24, Katraj, Dhankawadi, Pune (411043). The primary outcome measures will Improvement of visual acuity based on LOGMAR chart. The secondary outcomes will be Reduction in the symptoms of blurring of vision ,visualization of non existing things like dots,threads,etc; difficulty in day vision,glare; difficulty in night vision or dim light. |