Randomized control Clinical trial on efficacy of Ushiradi Taila Netrabhyanga in comparison with Hydroxypropyl Methylcellulose eye gel in the management of Shushkashipaka with special reference to dry eye disease
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- To assess the changes in subjective symptoms of Dry eye Disease
Study Overview
Brief Summary
Patients with confirmed diagnosis of Shushkashipaka(dry eye disease)will be informed about the trial and written consent will be taken. Interventions to both the groups will be given and assessment will be done based on which stastistical analysis will be made. Observations and results will be done based on statistical analysis
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients having symptoms of Shushkaakshipaka, patients of age group 40 years to 60 years, are randomly selected to maintain homogeneity.
- •Patients suffering from DED are selected irrespective of gender or socioeconomic status.
- •Patients with scores less than 15 mm on Schirmer’s test.
Exclusion Criteria
- •Patients with age groups below 40 years and above 60 years are excluded.
- •Patients suffering from ophthalmic infective diseases are excluded.
- •Patients with other major ophthalmic diseases like glaucoma, retinal abnormality are excluded.
Outcomes
Primary Outcomes
To assess the changes in subjective symptoms of Dry eye Disease
Time Frame: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
(Shushkakshipaka) in group A and group B.
Time Frame: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
2. To assess the pre and post study changes in Schirmer’s test, BUT test and Rose
Time Frame: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
Bengal Test in group A and group B.
Time Frame: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
To study the efficacy of Ushiradi taila netrabhyanga and HPMC gel in dry eye
Time Frame: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
disease.
Time Frame: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
2. To study ushiradi taila in detail.
Time Frame: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
3. To study netrabhyanga in detail and to prepare SOP of it.
Time Frame: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
4. To study probable mode of action of netrabhyanga in detail.
Time Frame: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
5. To study HPMC Gel and its properties.
Time Frame: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
Secondary Outcomes
- To study the efficacy of Ushiradi taila netrabhyanga and HPMC gel in dry eye(disease.)
Investigators
Dr Nikhil Naganath Mali
Ayurved Vidya Prasarak Mandal’s Ayurved Mahavidyalaya, Sion