A clinical trial to see the effect of some Ayurvedic formulation in the form of topical application in the treatment of Shushkakshipaka with reference to dry eye

Phase 2/3

Not yet recruiting

• Conditions: Other disorders of lacrimal system. Ayurveda Condition: Shushkakshipaka,

• Registration Number: CTRI/2021/02/031492
• Lead Sponsor: Sane Guruji Arogya Kendra

Brief Summary

This study is open Labelled randomised comparative clinical trial to evaluate the effect of Draksha Siddha Ghrita Aschyotana  twice a day for 21 days in comparison with Carboxy Methyl Cellulose 0.5% eye drops twice a day for 21 days in patients affected with shushkakshipaka w.r.t. Dry eye . The primary outcome will be effect of DrakshaSiddha Ghrita Aschyotana and the secondary outcome will be a comparison between trail drug and controlled drug in the management of Shushkakshipaka w.r.t. Dry eye

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-03
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1. Patients suffering from symptoms of Shushkakshipaka.
• 2. Age -19-65yrs.
• 3. Irrespective of Either gender.
• 4. Only those cases will be accepted for final assessment that successfully complete the treatment in given time.

Exclusion Criteria

• 1. Patients having complicated eye diseases or any severe occular infections like corneal ulcer etc.
• 2. Patients not ready for drug trial & follow up.
• 3. Patient having autoimmune disorders like RA, Sjogrens syndrome or any systemic diseases like Diabetic Mellitus, Hypertension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A Clinical study to evaluate efficacy of Draksha Siddha Ghrita Aschyotana in Shushkakshipaka w.r.t Dry eye. parameter of efficacy is Schirmers test before and after treatment	The drug will be given 21 days . the patient will be assessed before and after treatment . Total duration of study will be 18 months

Secondary Outcome Measures

Name	Time	Method
Comparison between efficacy of Draksha Siddha Ghrita Aschyotana in Shushkakshipaka w.r.t. dry eye	18 months

Trial Locations

Locations (1)

Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune 411028; 🇮🇳 Pune, MAHARASHTRA, India

Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune 411028

🇮🇳Pune, MAHARASHTRA, India

Vd Dhanashree Vitthal Gole

Principal investigator

8999248465

gole.dhanashree1994@gmail.com