CTRI/2024/09/073945已完成3 期
Evaluation of Efficacy and Safety of ANJANA in patients suffering from immature uncomplicated cataract-An open label, single-center, single-arm, prospective, interventional clinical study.
Netraum Ayurveda Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in lens evaluated on LOCS II in Slit lamp Test between subjects using ANJANA at visit 3 and visit 4 as compared to baseline visit.
研究概览
简要总结
Evaluation of efficacy and safety of ANJANA in patients suffering from immature uncomplicated cataract - An open label, Single Center, single arm, prospective, interventional clinical study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Patient willing to provide written informed consent 2.Premenopausal female of age 30 – 70 years 3.Subjects with immature (Asymptomatic or Symptomatic) and uncomplicated cataract not requiring surgery.
- •4.Subjects having cataract with possible grading on slit lamp bio microscopy according to Lenticular Opacity Classification System II.
- •5.Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.
排除标准
- •1.Subjects with congenital cataract, mature and hyper mature cataract.
- •2.Subjects having any other ophthalmic condition like glaucoma, diabetic retinopathy, macular degeneration, retinitis pigmentosa which requires urgent and separate treatment.
- •3.Subjects with Uncontrolled Diabetes and Uncontrolled Hypertension.
- •4.Subjects taking Steroid treatment and or any kind of immunosuppressive therapy.
- •5.Subjects participating in any other clinical study or having participated in any other Study 3 months prior to screening in the present study.
- •6.Subjects who are in general sensitive to any eye drops.
- •7.A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period.
- •8.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol.
结局指标
主要结局
Changes in lens evaluated on LOCS II in Slit lamp Test between subjects using ANJANA at visit 3 and visit 4 as compared to baseline visit.
时间窗: Baseline to EOS.
Changes in direct and indirect ophthalmoscopic examinations between subjects using ANJANA at visit 3 and visit 4 as compared to baseline visit.
时间窗: Baseline to EOS.
次要结局
- Comparative clinical assessment of symptoms related to cataract in visit 4 as compared to baseline visit.(Assessment of other changes in eyes-related symptoms like itching, tiredness, irritation, burning, etc. if any.)
研究者
Prof Dr Pradip Kumar Panda
Sri Sri College of Ayurvedic Science and Research Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
To examine the effect of Karanja Beeja Varti Anjan application in 84 participants (both male and female) of age group between 18 to 55 years with signs of progressive pterygium.CTRI/2025/03/083268Dr Manasi Surendra Karjini84
尚未招募
2/3 期
Effect of Kataphala bark (Myrica nagi) to alleviate breathlessness in individuals with Chronic Obstructive Pulmonary Disease.CTRI/2025/02/080052Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital30
尚未招募
不适用
To see the effect of Kanadi Churna Pratisarana and Madhu mishrit Panchvalkal Kwath gandush in Dantveshta (Pyorrhoea alveolaris)CTRI/2025/09/094584Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan60
尚未招募
2/3 期
Random Study on Bilvadi kwath (Divitya) in the management of acute watery diarrhoea-a clinical studyCTRI/2025/03/083538VIKASH120
尚未招募
不适用
A Comparative Clinical Study on Participants with Charmakeela (Warts) to Evaluate the Outcome of Karanja Pratisarneeya Ksharakarma and Tamra Shalaka AgnikarmaCTRI/2025/08/093467Dr Shreya Shrikant Kakare40