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CTRI Number  CTRI/2024/03/064365 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 16/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homeopathic medicines for dry eye disease 
Scientific Title of Study   Efficacy of individualized homoeopathic medicines in improving symptoms of dry eye disease in adults: A double-blind, randomized, placebo-controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1304-1293  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek Karmakar 
Designation  Postgraduate Trainee 
Affiliation  D. N. De Homoeopathic Medical College and Hospital 
Address  Dept. of Organon of Medicine, OPD Eye (room no. 3), 12, Gobinda Khatick Road, Kolkata

Kolkata
WEST BENGAL
700046
India 
Phone  8777390597  
Fax    
Email  abhishek4own@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subhasish Ganguly 
Designation  Principal-in-charge, Administrator, and Head 
Affiliation  D. N. De Homoeopathic Medical College and Hospital 
Address  Dept. of Organon of Medicine, OPD Eye (room no. 3), 12, Gobinda Khatick Road, Kolkata

Kolkata
WEST BENGAL
700046
India 
Phone  8017272982  
Fax    
Email  dr.subhasish67@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Subhasish Ganguly 
Designation  Principal-in-charge, Administrator, and Head 
Affiliation  D. N. De Homoeopathic Medical College and Hospital 
Address  Dept. of Organon of Medicine, OPD Eye (room no. 3), 12, Gobinda Khatick Road, Kolkata

Kolkata
WEST BENGAL
700046
India 
Phone  8017272982  
Fax    
Email  dr.subhasish67@gmail.com  
 
Source of Monetary or Material Support  
D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Kolkata 700046 
 
Primary Sponsor  
Name  D. N. De Homoeopathic Medical College and Hospital 
Address  12, Gobinda Khatick Road, Kolkata-700046 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Karmakar  D. N. De Homoeopathic Medical College and Hospital  Eye OPD (room no. 3), 12, Gobinda Khatick Road, Kolkata 700046
Kolkata
WEST BENGAL 		 8777390597

abhishek4own@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of D. N. De Homoeopathic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H162||Keratoconjunctivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical-looking placebos plus concomitant care  This group will receive placebos that look just like verum. Four cane sugar globules no. 40, moistened with 90% v/v ethanol, will be the dosage for each dose. These should be taken orally on an empty stomach, with a clean tongue. The dosage and frequency of administration will be determined by the specific needs of each case. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients of both groups will receive concomitant care in the form of general management which will include 0.9% normal saline solution. Duration of therapy: 3 months. 
Intervention  Individualized homoeopathic medicines in centesimal potencies plus concomitant care  The recommended homoeopathic medications will be administered in centesimal potencies (cH) as part of the planned intervention. Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients of both groups will receive concomitant care in the form of general management which will include 0.9% normal saline solution. Duration of therapy: 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Individuals with an ocular surface disease index score (OSDI) 13 to 32(mild to moderate) and a Schirmer-1 test wetness of less than 15 millimeters.
2. Individuals who are 18 to 65 years old.
3. Patients of either gender or transgender.
4. Participants having prior experience or knowledge of the treatment; e.g., primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet. 
 
ExclusionCriteria 
Details  1. Individuals with OSDI score more than 32 (severe).
2. Those who have had eye surgery or trauma during the last three months.
3. Individuals who decline to provide written informed consent.
4. Patients suffering from various ocular disorders, such as glaucoma or keratitis.
5. A patient whose systemic disorders are the cause of their DED.
6. Women who are breastfeeding or pregnant or in puerperium.
7. Those suffering from any type of autoimmune condition, such as Sjogren syndrome, SLE, etc.
8. Persons with simultaneous participation in any other clinical trial.
9. Vulnerable population- Unconscious, non-ambulatory, too sick for consultation,
differently abled, terminally ill or critically ill patients, mentally incompetent people.
10. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled
or life-threatening illness affecting quality of life or any organ failure.
11. Tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
12. Self-reported immune-compromised state AIDS, Hepatitis, etc.
13. A person with uncontrolled diabetes or any other uncontrolled systemic disorders.
14. A patient receiving continuous homoeopathic treatment for any other chronic illness. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Ocular Surface Disease Index (OSDI) scores  Baseline, every month, up to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Measure Yourself Medical Outcome Profile (MYMOP-2) questionnaire  Baseline, every month, up to 3 months 
Schirmer-1 test scores (without anaesthesia)  Baseline, every month, up to 3 months 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/04/2024 
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)
Modification(s)  		 Not Applicable 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [abhishek4own@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - N/A
Brief Summary   One of the most common eye diseases, dry eye disease (DED), affects millions of individuals worldwide. 5% to 50% of people worldwide have it, depending on the region they inhabit. Dry eye is a disorder of the tear film due to tear deficiency or excessive tear evaporation which causes damage to the interpalpebral ocular surface and is associated with symptoms of ocular discomfort. It is evident that there are numerous homoeopathic books that list symptoms of dry eye disease under various drugs, however, no conclusive evidence of efficacy of IHMs in DED is available until now. This research aims to alleviate the symptoms of dry eye disease by assessing OSDI scores, decrease the impact of contributing factors (mobile & laptop use etc.), improving the patient’s physical and emotional well-being, minimizing the adverse effects of artificial tear drops and determining if IHMs are more effective than placebo in treating DED. A double-blind, randomized, placebo-controlled trial will be conducted on 50 adults suffering from DED at the outpatients of D. N. De Homoeopathic Medical College and Hospital. Primary outcome measure is to achieve OSDI score 13-32. Secondary outcome measures are SIT, MYMOP2 scoring. All outcomes will be measured every month up to 3 months. Group differences will be analyzed statistically. Results will be published in scientific journals. 
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