A Study to Evaluate the Effect of Shatadhouta Ghritam (Medicated Ghee) Application in People with Dry Eye Disease

An open label randomized controlled clinical trial to study the efficacy of topical application of Shatadhouta Ghritam in Dry Eye Disease - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087199

Enrollment

Registered

2025-05-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H048- Other disorders of lacrimal system Health Condition 2: H578- Other specified disorders of eye and adnexa

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18 60 years of either sex. 2. Patients presenting with sign and symptoms of Dry Eye Disease. 3. TBUT less than 5 sec. 4. Schirmer test less than 10 mm. 5. Signed ICF (Informed Consent Form). 6. Ability and willingness to follow instructions, including participation in all study assessments and visits.

Exclusion criteria

Exclusion criteria: 1.Cases complicated with acute, chronic, infective conjunctivitis or any specific eyelid disorder, corneal ulcer, dacryocystitis and lagophthalmos. 2. Inflammatory diseases unrelated to Dry Eye Disease. 3. Patients suffering from any systemic disorder or taking any medications which may affect the clinical outcome of the trial. 4. Contact lens use. 5. History of ocular surgery within 6 months prior to enrolment in trial. 6. Chemical, thermal or radiation injury. 7. Patient who starts developing complications will be excluded from the study. 8. Ocular or periocular malignancy. 9. Use of topical steroids, topical immunomodulators, topical anti-glaucoma medication within 60 days before screening.

Design outcomes

Primary

Measure	Time frame
Overall change in Ocular Surface Disease Index (OSDI) Score in parameters namely burning sensation pain congestion irritation and drynessTimepoint: Overall change in Ocular Surface Disease Index (OSDI) Score in parameters namely burning sensation pain congestion irritation and dryness	—

Secondary

Measure	Time frame
Change in Tear Film Break-up Time (TFBUT) Change in Corneal Fluorescein Staining(CFS) assessed at day 15 day 30 Timepoint: Change in Tear Film Break-up Time (TFBUT) Change in Corneal Fluorescein Staining(CFS) assessed at day 15 day 30	—

Countries

India

Contacts

Public ContactAshok Kumar

Banaras Hindu University

mkumarbhu@gmail.com97931 27744

Outcome results