| CTRI Number |
CTRI/2025/07/091588 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Individualised Homoeopathy compared with Artificial tear drops in management of mild to moderate Dry Eye Disease |
|
Scientific Title of Study
|
A prospective three arm randomised pilot trial to evaluate the role of individualised Homoeopathy compared with Artificial Teardrops in managing mild to moderate dry eye disease DED. |
| 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 Deepti Singh |
| Designation |
Research Officer Homoeopathy Scientist-2 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Technical department, Room no 312, 61 65, Institutional Area, Jawahar Lal Nehru Bhartiya chiktsa avum homoeopathic Anusandhan bhawan, Ayush building, Sewa Marg, Opp D block Janak Puri
61 65 JANAKPURI INSTITUTIONAL AREA
sewa marg opp d block janakpuri
new delhi
West
DELHI
110058
India |
| Phone |
9818785593 |
| Fax |
|
| Email |
dr.deepti.2821@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Singh |
| Designation |
Research Officer Homoeopathy Scientist-2 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Technical department, Room no 312, 61 65, Institutional Area, Jawahar Lal Nehru Bhartiya chiktsa avum homoeopathic Anusandhan bhawan, Ayush building, Sewa Marg, Opp D block Janak Puri
61 65 JANAKPURI INSTITUTIONAL AREA
sewa marg opp d block janakpuri
new delhi
West
DELHI
110058
India |
| Phone |
9818785593 |
| Fax |
|
| Email |
dr.deepti.2821@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhash Kaushik |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No 408, 61 65, Institutional Area, Jawahar Lal Nehru Bhartiya chiktsa avum homoeopathic Anusandhan bhawan, Ayush building, Sewa Marg, Opp D block Janak Puri
61 65, Institutional Area, Jawahar Lal Nehru Bhartiya chiktsa avum homoeopathic Anusandhan bhawan, Ayush building, Sewa Marg, Opp D block Janak Puri
West
DELHI
110058
India |
| Phone |
9810788976 |
| Fax |
|
| Email |
subhashccrh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homeopathy, 4th floor, 61 65, Institutional area, Jawahar Lal Nehru bhartiya chikitsa avum homoeopathic anusandhan bhawan, Sewa Marg, Opp D Block Janakpuri, New Delhi 110058 |
| Type of Sponsor |
Government funding agency |
|
|
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 Mukesh Taneja |
Indira Gandhi Eye Hospital and Research Center |
Cornea department, Ground Floor,
CRPF Road, Near Heritage School Sector 62, Gurugram Haryana 122001
Gurgaon
HARYANA |
9912215021
mukeshtaneja@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H041||Other disorders of lacrimal gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Artificial tear drops |
Artificial tear drops shall be provided by the Ophthalmologist in the study |
| Intervention |
Individualised Homoeopathic medicines |
Homoeopathic drugs as detailed in the standard Homoeopathic Materia Medica and in the Homoeopathic Pharmacopoeia (India/US) will be used in the study based on symptom similarity (Homoeopathic principle). Dose and duration: The indicated Individualized Homoeopathy medicine shall be given in 30CH, 200 CH or 1M potency as per the prescribing totality of the case and discretion of physician with assessment at 6 months. Route of administration: The medicine would be taken orally. Repetition of medicine: The medicine will be repeated depending on the potency and complaints of the patient in accordance with the principles of Homoeopathy. The drug identified for the trial shall be procured from a GMP-compliant pharmaceutical firm approved by the Council.
|
| Intervention |
Individualised Homoeopathy + Artificial tear drops |
Individualised Homoeopathy along with preservative-free, and one-day-use or multiuse
artificial tear drops. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male or female patient aged 18 years or above.
Presenting with at least two of dry eye related symptoms, including itching, dryness, foreign body sensation, burning, blurred vision, photophobia, and soreness or pain etc in at least one of the eye.
Diagnosis of mild to moderate dry eye syndrome with or without Sjögrens syndrome.
Best corrected visual acuity 6/18.
Following results in at least one of the eye
Ocular Surface Disease Index OSDI test symptoms between 12 and 33
Tear film break up time less than or equal to 10 seconds in atleast one of the eye.
Willing to follow the study schedule and provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1 Complaints of ocular comorbidity including non-dry eye ocular inflammation, severe
blepharitis, glaucoma, contact lens allergy or any condition known to have effect on the study
outcome.
2 History of any Trauma or eye surgery during last 3 months
3 Presenting with any uncontrolled systemic disease or significant illness and other autoimmune
or connective tissue disorders such as rheumatoid arthritis and lupus, and thyroid disease.
4 Current use of topical ophthalmic medications that could affect dry eye syndrome and not
willing to stop.
5 Pregnant &/or lactating female or considering a pregnancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Ocular Surface Disease Index OSDI score
Change in intensity of symptoms of dry eye disease on VAS self-assessment of ocular discomfort reported by participants
|
Baseline, monthly for 06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Change in tear film break-up time
-Change in Tear osmolarity |
Baseline and end of treatment at 06 months |
|
|
Target Sample Size
|
Total Sample Size="192"
Sample Size from India="192"
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)
|
04/08/2025 |
| 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="2"
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
|
Dry eyes disease, also known as dry eye syndrome, or keratoconjunctivitis sicca (KCS), is a condition of insufficient moisture of eyes due to increased tear film evaporation or its decreased secretion leading to symptoms of ocular discomfort like excessive dryness, sensation of sand in eyes with gritty feeling, blurred vision, photophobia, redness of eyes with burning pains and overall eye discomfort. Homoeopathy which follows the individualised approach, consider the signs and symptoms of the person before prescribing medicine, is known to have beneficial role in management of Ophthalmological conditions. Not much published studies on effectiveness of individualized Homoeopathic medicines in the treatment of DED is available. So, more definitive comparative studies are required to prove the same
The current study has been designed with Primary objective to compare the efficacy of individualized Homoeopathic medicine alone, and in combination of artificial tear drops with artificial tear drops only in relieving signs and symptoms of mild to moderate DED. To determine change in Ocular Surface Disease Index (OSDI) before and after treatment between the groups. Secondary objective being assessment of the change in Tear osmolarity and tear film break-up time between the study groups. |