Evaluation of Comparative efficacy of Yastimadhu Ghrita eye drops along with Panchtikta Kshira Basti versus Yastimadhu Ghrita eye drops and Chakshusya Basti in the management ofdry eye Syndrom Associated Osteoarthritis A Pilot Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To access the efficacy of eye drops along with PanchtiktaKshirBasti versus eye drops and ChakshusyaBasti over Visual acuity Schirmer’s test Tear film breakup time Womac scale Pain Walking Physical Function
研究概览
简要总结
the volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Before the study approval has been taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done.After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a parallel group, randomized, open clinical, standard controlled trial. it will include a 24 days treatment period and at 48th day follow up period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to do Procedure were included consent of patient to do Procedure Age group 45 to 70 years Both sexes Patients with controlled hypertension up to normal to 140/90 mm of hg Controlled Diabetes mellitus patients Range 100 to 160 with medication Patient with BMI up to 30.
排除标准
- •Uncontrolled HT and DM Traumatic arthritis Post cataract surgery up to 1 year knee joint replaced Contraindicated for basti and Aschyotan Dry eyes not associated with OA example dry eye due to Graves disease Hashimotos disease primary and secondary Sjogrens syndrome.
结局指标
主要结局
To access the efficacy of eye drops along with PanchtiktaKshirBasti versus eye drops and ChakshusyaBasti over Visual acuity Schirmer’s test Tear film breakup time Womac scale Pain Walking Physical Function
时间窗: 24 days
range of Motion
时间窗: 24 days
次要结局
- Comparison and assessment of efficacy of eye drops along with PanchtiktaKshirBasti versus eye drops and ChakshusyaBasti in Visual acuity Schirmer’s test Tear film breakup time Womac scale Pain Walking Physical Function range of Motion(3 week 3 days)
研究者
Dr Roshna Bhutada
Mahatama Gandhi Ayurved College Hospital And Research Centre