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CTRI Number  CTRI/2024/03/063458 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 27/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of oral curcumin in improving ocular health 
Scientific Title of Study   Efficacy of oral Curcumin in Ocular Surface Disease of Glaucoma Patients on topical therapy 
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 Ophthalmology 
Affiliation  Aiims New Delhi 
Address  Room no. 707, 7th floor, Dr. Rajendra Prasad Centre For Ophthalmic Sciences Aiims, Ansari Nagar

New Delhi
DELHI
110029
India 
Phone  01126593171  
Fax    
Email  shikhagupta@aiims.edu  
 
Details of Contact Person
Scientific Query  
Name  Shikha Gupta 
Designation  Associate Professor Ophthalmology 
Affiliation  Aiims New Delhi 
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 AIIMS, Ansari Nagar
New Delhi
DELHI
110029
India 
Phone  01126593171  
Fax    
Email  shikhagupta@aiims.edu  
 
Details of Contact Person
Public Query  
Name  Shikha Gupta 
Designation  Associate Professor Ophthalmology 
Affiliation  Aiims New Delhi 
Address  Dr. Rajendra Prasad Centre For Ophthalmic Sciences Aiims,Ansari Nagar New Delhi
Room No. 615, 6th Floor Glaucoma Facility Lab Dr. R P Centre Aiims Ansari Nagar New Delhi
New Delhi
DELHI
110029
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 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  Glaucoma Facility Lab 615,6th floor Dr. R P Centre Aiims,Ansari Nagar
New Delhi
DELHI 		 01126594127

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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H42||Glaucoma in diseases classified elsewhere, (2) ICD-10 Condition: H404||Glaucoma secondary to eye inflammation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laurica K capsule   One capsule a day f0r three months Will be given Orally. Curcumin act as anti inflammatory,anti oxidative agent in Ocular surface disease patients  
Comparator Agent  Sodium Hyaluronate, Carboxymethylcellulose, dextran  1 drop, three times a day, will be given topically to act as a lubricating agent. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients willing to give consent for the study.
Age more than equal to 18 years
On 2 or more glaucoma drugs for at least 6 months showing some OSD.
Ocular Surface Disease Index(OSDI) questionnarie more than 15.  
 
ExclusionCriteria 
Details  Not willing to follow up
Age less than 18 yrs
Any patients with recent ocular surgery in past 3 months or secondary inflammatory conditions causing glaucoma eg,vernal keratoconjunctivitis(VKC),uveitis,sclerouveitis etc
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 
Objectiven Improvement in Ocular Surface Disease Index Score,Tear Break Up Time,Schiermer
 		 4 Weeks
8 Weeks
12 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in clinical parameters of patients like Intraocular Pressure & ocular surface analyzer  4 Weeks
8 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)   08/03/2024 
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="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  

As per the available knowledge, there is a paucity of research examining the efficacy of curcumin capsules in treating OSD induced by glaucoma medications. This study aims to bridge this gap by investigating the potential benefits of curcumin, known for its anti-inflammatory and antioxidant properties, in ameliorating OSD symptoms linked to glaucoma medication usage. The proposed research intends to explore the effects of oral curcumin capsules on ocular surface health, and patient-reported outcomes in individuals experiencing OSD secondary to glaucoma medications.By identifying this gap in the literature, it aims to offer insights into novel therapeutic avenues for managing OSD specifically associated with glaucoma medication use, potentially enhancing patient comfort and treatment adherence.

 The primary objective of this study is to assess the efficacy and safety of oral curcumin capsules in managing ocular surface diseases (OSD) induced by using glaucoma medications. Specifically, the study aims to:

·       a.To evaluate the impact of oral curcumin capsules on reducing OSD symptoms, including dryness, irritation, redness, and discomfort among individuals experiencing ocular surface complications because of glaucoma medications.

·       b.To investigate the effects of oral curcumin capsules on improving objective measures of ocular surface health, such as tear film stability, corneal surface changes, and epithelial integrity through clinical examinations.

Baseline examination, including best corrected visual acuity, slit lamp bio-microscopy, gonioscopy/ gonio photography, fundus examination (+90D lens), Intra-occular pressure (IOP) and applanation diurnal phasing of IOP will be recorded.Intervention:

Treatment Group/ Group 1: This group will be administered with oral curcumin capsules orally as per a predetermined dosage regimen for at least three months or till any side effects appear.

Control Group/ Group 2: This group will be receiving standard treatment for OSD caused by glaucoma medications.

Curcumin capsules will be made available in the form of Laurica K (HIS Eyeness Ophthalmic’s Pvt Ltd Co, India) soft gel capsules. Laurica K, comprising Curcuma Longa (curcumin). MCT Oil, Piperine will be administered once daily to the patients.

Follow-up Visits and Assessments

Regular follow-up visits will be conducted to monitor participants’ progress and to assess various parameters done post related to ocular health, ocular surface disease severity (OSDI scoring), and glaucoma progression in both the experimental (oral curcumin ) and control (standard treatment) groups.

Duration and Assessment Frequency:

Follow-up visits will occur initially at 4 weeks and followed by at 8 weeks and 3 months after enrolment. At each visit, comprehensive evaluations will be performed to track changes and progression in ocular parameters and glaucoma status.

Assessments Include:

Ocular Parameters:

·       For dry eyes evaluation: TBUT, Schiemer

·       Intraocular pressure measurements

·       Other relevant ocular evaluations as deemed necessary

·       Ocular Surface Analyzer (OSA)

OSDI Scoring:

The evaluation of ocular surface disease severity will be conducted by utilizing the Ocular Surface Disease Index (OSDI) questionnaire. This validated assessment tool will enable an in-depth evaluation of the impact of ocular surface disease on participants’ quality of life, providing valuable insights into the severity and effect of the condition.

Duration of Follow-up:

The follow-up period will extend over 3 months to comprehensively monitor changes in ocular health and disease progression.

Data Collection and Analysis:

The study will involve the collection and recording of data concerning changes in visual parameters, disease progression, disease severity and any adverse effects experienced by participants. In the data analysis phase, statistical methods will be employed to compare outcomes between the treatment and control groups. Additionally, within the group, a comparative analysis will be conducted to assess the parameters pre- and post-intervention.

 
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