A Clinical Study on Combined Effectiveness of Oral and Topical Application of an Ayurvedic Medicine - Agastya Ghrita in the Management of Retinitis Pigmentosa

Phase 2

Recruiting

• Conditions: Shleshma vidagdha Drishti( Retinitis pigmentosa)

• Registration Number: CTRI/2017/05/008552
• Lead Sponsor: Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital

Brief Summary

This study is a non randomized single arm clinical trial assessing the effectiveness of Agastya ghrita pana and Tarpana in the management of Shleshmavidagdha Drishti( Retinitis pigmentosa). 30 patients will be enrolled for this study for one month.This study period will be  one and half year.The primary outcome measures will be reduction of night blindness, reduction of peripheral visual field loss and blurredness of vision. The secondary out come will be controls of  the further deterioration of night blindness, reduced peripheral visual field and blurredness of vision. Baseline data will be assessed after the treatment and in first follow up after treatment i.e 45th and 60th day of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-20
• Last Update Posted: 2017-09-03

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient ready to sign in informed consent form irrespective of sex, and religion.
• Naktandhata (night blindness) 2.
• Difficulty in dark adaptation 3.
• Reduced field of vision 4.Blurredness of vision 5.Visual acuity test revealing reduced visual acuity.
• 6.Perimetry showing peripheral visual field defect 7.
• Opthalamoscopic evaluation of Fundus revealing classical triad of Retinitis pigmentosa (arteriolar attenuation, retinal bone-spicule pigmentation and waxy pallor).
• Pictorial assessment of Retinitis pigmentosa through Fundal photograph.

Exclusion Criteria

• 1.Patients having total blindness.
• 2.Patient with all kind of diabetic retinopathy and diabetic maculopathy.
• 3.Patient with pregnancy and lactating period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity test revealing visual acuity improving	1 month
Improvement in nightblindness	1 month
improvement in dark adaptation	1 month
improvement of field of vision	1 month
Perimetry showing peripheral visual field changes	1 month
Fundal pictorial changes	1 month

Secondary Outcome Measures

Name	Time	Method
it checks the further deterioration of nightblindness, reduced peripheral visual field and blurredness of vision.	1 month

Trial Locations

Locations (1)

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital; 🇮🇳 Hassan, KARNATAKA, India

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital

🇮🇳Hassan, KARNATAKA, India

Dr Pushpa Raj Poudel

Principal investigator

9035906765

pundanraj@gmail.com