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A Study Comparing Durva Eye Drop and eye oinment with artificial tear drops in Patients with Dry Eye Disease.

Efficacy of durva-based formulations versus artificial tear drops (carboxy methyl cellulose and hyaluronic acid) in dry eye disease.An open label double arm randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104855
Enrollment
98
Registered
2026-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: H041- Other disorders of lacrimal gland

Interventions

None listed

Sponsors

All India Institute of Ayurveda, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients willing for the treatment. Patients having the clinical features of Sushkakshipaka (Dry Eye Disease). Patients of 18-50 years having mild to moderate dryness of eye.(OSDI Score upto 32) Schirmer s Test- less than 15mm in 5 min. Tear film break up time- less than 10s

Exclusion criteria

Exclusion criteria: The patients who are planning for ocular and/or lid surgeries within the study period. Patients having uncontrolled systemic disease. Severe cases of dry eye syndrome with complications like corneal ulcer, glaucoma uveitis. Allergic and inflammatory conditions of eye like Acute conjunctivitis, Vernal keratoconjunctivitis, giant papillary conjunctivitis. Patients on steroids, oral contraceptive pills, oestrogen replacement therapy or any other medication such as antispasmodic drugs like Atropine that may adversely affect the outcome of the study.

Design outcomes

Primary

MeasureTime frame
To evaluate the effects of Durva Ghrita Eye Drop along with Durva Ghrita ointment and tear substitute in patients suffering from Shushkakshipaka (Dry eye) on foreign body sensation and pro-inflammatory effect by quantifying levels of pro-inflammatory cytokines in tear film, which are known biomarkers associated with ocular surface inflammation. Timepoint: 24 weeks

Secondary

MeasureTime frame
To evaluate the efficacy of Durva Ghrita eye drops along with Durva Ghrita eye ointment and tear substitute in the management of Dry eye disease on other subjective and objective parameters. Changes in the quality of life before & after the treatment- assessed according to OSDI score. To find out computational correlation of Gene-target-disease among bio actives of ingredients of Durva Ghrita against Dry Eye Disease (DED). To assess the patient acceptability and record any potential adverse effects. Timepoint: 24 weeks

Countries

India

Contacts

Public ContactDr Narayan Bavalatti

All India Institute of Ayurveda, New Delhi

eyenimi@gmail.com9650715615

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026