| CTRI Number |
CTRI/2023/03/050531 [Registered on: 10/03/2023] Trial Registered Prospectively |
| Last Modified On: |
02/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To check the effect of NIF herbal medication (eye drop) in senile immature cataract condition. |
|
Scientific Title of Study
|
Evaluation of anti-Cataract activity of NIF herbal medication [Eye drop] in Senile Immature Cataract condition. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Santosh Shivaji Mulik |
| Designation |
Professor and HOD |
| Affiliation |
Bharati vidyapeeth (Deemed to be university) college of Ayurved. |
| Address |
Department of shalakyatantra Bharati vidyapeeth (Deemed to be university) college of Ayurved and hospital pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7972169740 |
| Fax |
|
| Email |
mulik.santosh@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Shivaji Mulik |
| Designation |
Professor and HOD |
| Affiliation |
Bharati vidyapeeth (Deemed to be university) college of Ayurved. |
| Address |
Department of shalakyatantra Bharati vidyapeeth (Deemed to be university) college of Ayurved and hospital pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7972169740 |
| Fax |
|
| Email |
mulik.santosh@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh Shivaji Mulik |
| Designation |
Professor and HOD |
| Affiliation |
Bharati vidyapeeth (Deemed to be university) college of Ayurved. |
| Address |
Department of shalakyatantra Bharati vidyapeeth (Deemed to be university) college of Ayurved and hospital pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7972169740 |
| Fax |
|
| Email |
mulik.santosh@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| National Innovation Foundation,Gandhinagar,Mahudi road,Amrapur,382650 India |
|
|
Primary Sponsor
|
| Name |
National Innovation Foundation |
| Address |
Gandhinagar, Mahudi road, amrapur, 382650 India |
| Type of Sponsor |
Other [Research Institution] |
|
|
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 Santosh Shivaji Mulik |
Bharati vidyapeeth (Demeed to be university) college of ayurved and hospital, pune |
Bharati vidyapeeth (Demeed to be university) college of ayurved and hospital, pune
Pune
MAHARASHTRA |
7972169740
mulik.santosh@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BV (DU) COA- EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Herbal medication (eye drop) provided by NIF |
1 drop three times a day
Total duration-6 months |
| Comparator Agent |
Commercial Lubricating eye drop |
1 drop three times a day
Total Duration- 6 months |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
The inclusion criteria is to have patients with age Group 60 years and above either gender diagnosed with Senile immature Cataract |
|
| ExclusionCriteria |
| Details |
The exclusion criteria for the research program viz., Cataracts other than senile immature cataract; History of any Systemic diseases; If HbA1C more than 6.5; Patients having Glaucoma; Corneal ulcer, Dacryocystitis or any type of Ocular surface or retinal pathology will be excluded, Sluggish Pupillary reaction; Hypersensitivity to the test drug and Patient(s) not willing to give consent. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Medicine will likely delay or arrest the progression of senile immature cataract. |
6 months study with three follow up ( 2nd month, 4th month, 6th month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The nature of visual functional ability of clinically diagnosed patient will be improved. |
6 months study with three follow up ( 2nd month, 4th month, 6th month) |
|
|
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 |
|
Date of First Enrollment (India)
|
01/04/2023 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study will be undertaken for evaluation of NIF herbal medication by conducting clinical trials in senile immature cataract patients. It is known that diabetes also contributes in the maturity of cataract, the present clinical study will be exclusively conducted on non-diabetic patients. This will be based on investigation of HbA1c having value less than 6.5 for individuals with senile immature cataract. As no proven medicine is available for cataract, control group patients will be given commercial lubricating eye drop. This clinical trial will include 100 cataract eyes of Senile Immature Cataract which will randomly divided into 2 groups viz., Test Group I and Test Group II [Trial Group for Test medication include 75 cataract eyes and Control group for Commercially available lubricating drop include 25 cataract eyes]. In case patients having both eyes affected with senile immature cataract, those will be considered as two samples and data will be organized accordingly.
|