CTRI/2020/10/028381
Not yet recruiting
Phase 1
A Randomized Clinical study to evaluate the efficacy of Bibhitakadi Ghrita Tarpana and Ayastha Triphala with Ghrita as oral intake in the management of Timira w. s. r. to Presbyopia
ational Institute of Ayurveda Jaipur0 sites0 target enrollmentTBD
ConditionsHealth Condition 1: H524- Presbyopia
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: H524- Presbyopia
- Sponsor
- ational Institute of Ayurveda Jaipur
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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