| CTRI Number |
CTRI/2024/09/073759 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
Role of curcumin in improving vision in advanced glaucoma patients |
|
Scientific Title of Study
|
Efficacy of oral curcumin in improving visual function in eyes with advanced stage glaucoma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikha Gupta |
| Designation |
Associate Professor |
| Affiliation |
Aiims, New Delhi |
| Address |
Room no. 707, 7th floor, Dr. Rajendra Prasad Centre For Ophthalmic Sciences Aiims, Ansari Nagar
New Delhi
110029
India
South
DELHI
110030
India |
| Phone |
01126593171 |
| Fax |
|
| Email |
shikhagupta@aiims.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Shikha Gupta |
| Designation |
Associate Professor |
| Affiliation |
Aiims, New Delhi |
| Address |
Room no. 707, 7th floor, Dr. Rajendra Prasad Centre For Ophthalmic Sciences Aiims, Ansari Nagar
New Delhi
110029
India
DELHI
110030
India |
| Phone |
01126593171 |
| Fax |
|
| Email |
shikhagupta@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shikha Gupta |
| Designation |
Associate Professor |
| Affiliation |
Aiims, New Delhi |
| Address |
Room no. 707, 7th floor, Dr. Rajendra Prasad Centre For Ophthalmic Sciences Aiims, Ansari Nagar
New Delhi
110029
India
DELHI
110030
India |
| Phone |
01126593171 |
| Fax |
|
| Email |
shikhagupta@aiims.edu |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029,India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Dr. Rajendra Prasad Centre For Ophthalmic Sciences All India Institute of Medical Sciences, Ansari Nagar
Room No. 707, 7th floor Dr. R P Centre All India Institute of Medical sciences, Ansari Nagar
New Delhi
DELHI
110029
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 Shikha Gupta |
All India Institute of Medical Sciences, New Delhi |
Dr. Rajendra Prasad Centre For Ophthalmic Sciences All India Institute of Medical Sciences, Ansari Nagar
Room No. 707, 7th floor Dr. R P Centre All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India
South
DELHI |
01126593171
shikhagupta@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee All India Institute Medical Sciences, Room No 102,1st Floor Old O.T Block,Ansari Nagar, New Delhi 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H42||Glaucoma in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hydroxy Propyl Methyl Cellulose,Sodium Hyaluronate etc |
Given topically twice and thrice a day. |
| Intervention |
Oral curcumin capsule |
One (1) capsule of curcumin will be given orally /per day for three (3) months, Curcumin acts as an anti-oxidative and anti-inflammatory agent. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
The following patients will be included in the study
1.Patients willing to give consent for the study
2.Age 18 to 80 years.
3.Patients with advanced stage glaucoma in at least one eye and well-controlled IOP (less than 16 mmHg) in that eye with a Snellen visual acuity of at least 6 by 36.
4.If both eyes of the patient were eligible the eye with the better visual field was included in the study
|
|
| ExclusionCriteria |
| Details |
1.Not willing to follow up.
2.Age less than 18 years
3.Any patient with recent ocular surgery in past 3 months or secondary inflammatory conditions causing glaucoma eg, vernal keratoconjunctivitis (VKC), uveitix, sclerouveitis etc.
4.Patients with contraindications to curcumin or any related allergies.
5.Patients with any other disease that might have contributed to visual field loss at the time of initial visual-field test such as other optic neuropathies, stroke, brain tumors, retinal vein or artery occlusion, macular disease, cataract and proliferative diabetic retinopathy.
6.Any recent surgery in last 3 months
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Perimetry
2.Cup-Disc-Ratio (CDR)
3.Optical Coherence Tomography Angiography (OCTA)
|
4 Weeks, 6 Weeks, 12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Multifocal Electroretinography (Mf-erg) |
4 Weeks, 6 Weeks, 12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/09/2024 |
| 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="6"
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
|
Potential
Novelty of the Proposed Study:
As
per the available knowledge, there is a paucity of research examining the
efficacy of oral curcumin capsules supplimentation in treating advanced glaucoma patients. This
study aims to bridge this gap by investigating the potential benefits of
curcumin, known for its anti-inflammatory and antioxidant properties, in
improving visual functions in advanced glaucoma patients.
Rationale of the study:
The rationale for conducting a
study on administering oral curcumin alongside standard glaucoma therapy in
advanced glaucoma patients lies in the potential synergistic effects of
curcumin supplementation. While conventional treatments focus on lowering
intraocular pressure, curcumin offers a complementary approach by targeting
underlying mechanisms of neurodegeneration and inflammation. |