A Pilot Clinical Study to Assess the Effect of Netra-Tarpana on Certain Ocular Parameters in Patients with Myopia.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
Study Overview
Brief Summary
Purpose: To assess the effect of Netra-Tarpana (utilizing Mahatriphaladi ghrita) on certain ocular parameters, including best corrected visual acuity (BCVA), refractive error, prescription strength, keratometry readings, axial length, and intraocular pressure (IOP) in individuals with myopia.
Study Design: Clinical, prospective, open-labeled, single-group, single-blind, pilot study.
Participants: (n = 40) Patients of either gender, aged 10-45 years, diagnosed with myopia with spherical equivalent refractive error between -0.5 to -6.0 diopters, with stable refractive status for at least six months prior to enrollment. The diagnosis of myopia will be made on baseline day (day 0) using objective (retinoscopy, autorefractometer) and subjective refraction, and the spherical equivalent will be recorded for best corrected visual acuity.
Methods: All recruited participants (n = 40) will undergo Poorva Karma (local snehana with Tila Taila, Mridu Swedana, and Nasya with Shadbindu Taila), followed by Pradhana Karma - Netra-Tarpana with Mahatriphala Ghrita (30 ml) for three seven-day sittings at fifteen-day intervals - and Pashchat Karma with lukewarm-water Netra-Prakshalana. Standardized and certified formulations will be used. Baseline evaluation will include visual acuity, refraction, slit-lamp and fundus examination, IOP measurement, keratometry, and A-scan biometry. All parameters will be assessed before and after each sitting; changes in refractive status and ocular findings will be documented, and participant feedback will be recorded. follow-up will occur on day 0, 7, 23, 29, 45, 52.
Main Outcome Measures: The primary efficacy outcomes will include changes in visual acuity and spherical equivalent refractive error from baseline to the end of treatment. Secondary outcomes will assess changes in keratometry readings, axial length, anterior chamber depth, and intraocular pressure over the study period.
Results: The mean change in all assessment parameters will be analyzed using appropriate parametric or non-parametric statistical tests, as recommended by the statistician, to compare baseline and post-treatment values. A p-value of 0.05 or less will be considered statistically significant for all analyses.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 10.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients who meet the following criteria will be selected for the study:
- •Patients aged 10 to 45 years.
- •Patients diagnosed with myopia with spherical equivalent refractive error between minus 0.5 to minus 6.0 diopters.
- •Patients with stable refractive status for at least six months prior to enrollment.
- •Patients without any systemic disease that may affect ocular health, such as uncontrolled diabetes or autoimmune disorders.
- •Patients who are able and willing to provide written informed consent and are likely to complete the entire course of the study as per instructions.
Exclusion Criteria
- •Patients will be excluded from enrollment if they have:
- •High myopia with spherical equivalent refractive error greater than minus 6.0 diopters.
- •History of ocular surgery, such as refractive or cataract surgery, within the past one year.
- •Presence of ocular pathology other than myopia, such as glaucoma, retinal detachment, or macular degeneration.
- •Female patients who are pregnant, planning pregnancy during the study period, or lactating.
- •Current use or planned use of contact lenses during the study period.
- •Severe dry eye syndrome or any ocular surface disease that may affect study outcomes.
- •Use of ocular medications such as topical steroids or anti-glaucoma drugs that may interfere with the assessment of outcomes.
- •Inability to continue the proposed duration of treatment or attend follow-up visits.
- •Current participation in another clinical trial or participation in an ocular clinical trial within the past three months.
Investigators
Dr Varsha Raj
Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India.