Role of local Ayurveda therapy along with certain oral drug in the management of Presbyopia

Phase 1/2

Not yet recruiting

• Conditions: Presbyopia,

• Registration Number: CTRI/2020/10/028381
• Lead Sponsor: National Institute of Ayurveda Jaipur

Brief Summary

The study will be a Randomized clinical Trial phase 1/ phase 2.

Purpose- To evaluate and compare the efficacy of Bibhitakadi Ghrita Tarpana and Aystha Triphala with Ghrita as oral intake in the management of Timira  w. s. r. to Presbyopia.

- Group I: 30 patients of prathama and dwitiya patalagata timira (Presbyopia) will be administered Bibhitakadi ghrita Tarpana  topically.

- Group II: 30 patients of prathama and dwitiya patalagata timira (Presbyopia) will be administered Bibhitakadi ghrita Tarpana  topically along with Ayastha Triphala kwatha with goghrita oral intake at bedtime.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-12
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

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

Inclusion Criteria

• i) Patients willing to participate in this trial through written informed consent ii) Patients who are 35 years of age and from either sex ii) Patients having specific symptoms of prathama and dwitiya patalagata timira.
• iii) Early to moderate presbyope determined by screening monocular best-corrected distant visual acuity (VA).

Exclusion Criteria

• i) Patients with active ocular infection at visit 1 (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (eg, moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis), moderate to severe dry eye in either eye.
• ii) Patients with clinically significant abnormal lens findings (eg cataract) including early lens changes and/or any evidence of media opacity in either eye iii) Patients having intraocular pressure (IOP) that is less than 5 millimeters of mercury (mmHg) or greater than 22 mmHg in either eye documented at visit 1, or have a prior diagnosis of ocular hypertension or glaucoma or currently being treated with any type of topical IOP lowering (glaucoma) medication at visit 1.
• iv) Patients who have abnormal findings on dilated fundus exam in either eye on visit 1 or a known history of retinal detachment or clinically significant retinal disease in either eye.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare the efficacy of Bibhitakadi Ghrita Tarpana and Aystha Triphala with Ghrita as oral intake in the management of Timira w. s. r. to Presbyopia	45 days

Secondary Outcome Measures

Name	Time	Method
Any adverse event reported voluntarily, observed or enquire

Trial Locations

Locations (1)

National institute of Ayurveda Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

National institute of Ayurveda Hospital

🇮🇳Jaipur, RAJASTHAN, India

Dr Prabhakar Vardhan

Principal investigator

9461065960

shalakya007@gmail.com