CTRI/2012/12/003259已完成不适用
A single centric, open labeled, observational study of selected ayurvedic therapies in the management of diabetic retinopathy, grade-1.
Dept of AYUSH Ministry of HealthGovt of IndiaNew Delhi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年7月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fundus Photographs
研究概览
简要总结
This is an objective of the study isto evaluate the efficacy and safety of Ayurvedic treatment procedure andmedications in Non proliferative Diabetic Retinopathy in SreedhareeyamAyurvedic Eye Hospital & Research Centre, Koothattukulam, ErnakulamDistrict, Kerala, India.
The aim of the studyis not to understand the efficacy of any medicine in particular, but theefficacy of proposedAyurvedic treatment principles in combatingNon-proliferative Diabetic Retinopathy.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex aged between 30 to 80 years.
- •Patients presenting with signs and symptoms of Diabetic Retinopathy grade 1(US) with micro aneurysm and hemorrhage in one or two quadrants as seen in the Fundus Image.
- •Willing and able to participate in the study for 12 months.
排除标准
- •Severe cases of Diabetic Retinopathy with complications like internal haemorrhage, hard exudates, retinal detachment etc.
- •Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S.
- •creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
- •Patient with poorly controlled Diabetes Mellitus (HbA1c > 10%) Women who are pregnant or lactating.
- •Patient on steroids, oral contraceptive pills or estrogen replacement therapy.
- •Smokers/Alcoholics and/or drug abusers.
- •Patient with poorly controlled Hypertension (>160/100 mm of Hg).
- •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.).
- •Any other condition which the P.I. thinks may jeopardize the study.
结局指标
主要结局
Fundus Photographs
时间窗: Baseline,Second Inpatient visit, Third Inpatient visit and End of study visit
次要结局
- Fasting Blood Sugar,Post parandial Blood Sugar,LLiver Function Test, Renal Function Test(Baseline and End of Study Visit)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
A observational study to evaluate the efficacy and safety of Ayurvedic treatment in eyes affected by Progressive MyopiaCTRI/2013/05/003614Dept of AYUSH Ministry of HealthGovt of IndiaNew Delhi50
已完成
Unknown
A Clinical Trial to assess the Efficacy and Safety of Ayurvedic Dant ManjanCTRI/2018/01/011253Manisha Sales50
尚未招募
3 期
To evaluate efficacy of Traditional Ayurvedic Formulation (Divya Santati Sudha) in female infertility.CTRI/2023/08/056245Patanjali Research Institute governed by Patanjali Research Foundation Trust69
已完成
2 期
Clinical trial of CIM-Meg19 in COVID-19 patientsCTRI/2021/05/033543Ms Meghdoot Gramodyog Sewa Sansthan80
招募中
2 期
Effect of Drakshadi Ghritapana, Vasanjana and Anutaila Nasya on Shushkakshipaka (Dry Eye Syndrome)CTRI/2013/06/003736Institute for post graduate teaching and research in Ayurveda Gujarat Ayurved University Jamnagar100