MedPath

Homeopathic medicines for dry eye disease

Phase 2
Conditions
Health Condition 1: H162- Keratoconjunctivitis
Registration Number
CTRI/2024/03/064365
Lead Sponsor
D. N. De Homoeopathic Medical College and Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Ocular Surface Disease Index (OSDI) scoresTimepoint: Baseline, every month, up to 3 months
Secondary Outcome Measures
NameTimeMethod
Measure Yourself Medical Outcome Profile (MYMOP-2) questionnaireTimepoint: Baseline, every month, up to 3 months;Schirmer-1 test scores (without anaesthesia)Timepoint: Baseline, every month, up to 3 months
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