A clinical study to evaluate the efficacy of Sougathanjanam in Prathama patalagata timira( simple myopia)
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- reduction in symptoms and 0.5d improvement in clinical refraction
Study Overview
Brief Summary
For Simple Myopia optical treatment is commonly advised such as using spectacles, contact lenses and refractive surgeries . In Ayurvedic Classics various internal medications and Kriyakalpas has been explained to improve the vision and also to prevent the occurrence of disease. Anjana is one among the therapeutic procedure mentioned. Anjana Karma is a Kriyakalpa which is easy to apply, the medicines are easily available at a very affordable price. Hence the present study is conducted to evaluate the efficacy of Sougathanjanam in the management of Prathama Patalagata Timira (Simple Myopia)
HYPOTHESIS ï‚· Hâ‚€- There is no statistically significant effect with Sougathanjanam in the management of Prathama Patalagata Timira. ï‚· Hâ‚- There is statistically significant effect with Sougathanjanam in the management of Prathama Patalagata Timir
DIAGNOSTIC CRITERIA.  Patients with Lakshana of Prathama Patalagata Timira i.e., Avyaktha Darshana (Blurred Vision having dioptric power less than -6D and having Asthenopic symptoms like headache, eye strain and watering of eyes) Defective Distant Vision detected by  Snellen’s Distant Vision chart.  Auto refractometry.  Streak Retinoscopy
INCLUSION CRITERIA ï‚· Patients fulfilling the Diagnostic Criteria. ï‚· Patients between the age group of 05-21years. ï‚· Patients having dioptric power less than -6D.
EXCLUSION CRITERIA ï‚· Patients with, Dwiteeya, Triteeya and Chaturtha Patalagata Timira. ï‚· Patients having other Refractive errors except simple myopia. ï‚· Anjana Anarha9 ï‚· Patients with other systemic disorders that may interfere with the study. ï‚· Patients with history of ocular trauma and surgeries. ï‚· Patients with other ocular pathologies.
intervention : Sougathanjanam, 1 harenu matra(40mg) for 48 days. total duration of the study is of 180 days.
SUBJECTIVE PARAMETERS 1. Defective distant vision assessed by Snellen’s Distant Vision Chart. 2. Asthenopic Symptoms  Headache  Watering of eyes  Eye strain
OBJECTIVE PARAMETERS 1. Auto Refractive Reading 2. Streak Retinoscope
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 5.00 Year(s) to 21.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients fulfilling the Diagnostic Criteria.
Exclusion Criteria
- •Patients with, Dwiteeya, Triteeya and Chaturtha Patalagata Timira.
- •Patients having other Refractive errors except simple myopia.
- •Anjana Anarha 4)Patients with other systemic disorders that may interfere with the study.
- •ï‚· Patients with history of ocular trauma and surgeries.
- •ï‚· Patients with other ocular pathologies.
Outcomes
Primary Outcomes
reduction in symptoms and 0.5d improvement in clinical refraction
Time Frame: 48 days
Secondary Outcomes
- improvement in unaided visual acuity(96, 180 days)
Investigators
Dr Sunitha P
Alva’s Ayurveda Medical College and Hospital