CTRI/2020/10/028381尚未招募1/2 期
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
National Institute of Ayurveda Jaipur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月12日最近更新:
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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).
排除标准
- •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
- •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.
结局指标
主要结局
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
时间窗: 45 days
次要结局
- Any adverse event reported voluntarily, observed or enquire
研究者
研究点 (1)
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