A Prospective Open Labelled non randomized phase II Clinical trial on Alli Choornam in management of Kapha Neerizhivu noi(Diabetic Peripheral Neuropathy)
试验速览
- 阶段
- 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
- During treatment or after treatment reduction of following symptoms
研究概览
简要总结
The study is a prospective open labelled phase II non-randomised clinical trial to evaluate the efficacy of Alli Chooranam in the management of Kapha Neerizhivu(Diabetic peripheral neuropathy).The trial drug will be administered at the dose of 72mg/Kg/BW/Twice a day After food for 90 days with luke warm water as adjuvant in 60 patients.The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital Playamkottai Tirunelveli Tamilnadu. The primary outcome will be the evaluation of therapeutic efficacy of trial drug Alli Chooranam. The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of safety profile of trial drug,assessment of pharmacological and biochemical actions of the trial drug.In case of any adverse event (AE) is noticed it will be referred to pharmacovigilance department of SCRI. Furthur management of the patient will be given in OPD facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 36.00 Year(s) 至 68.00 Year(s)（—）
- 性别
- All
入选标准
- •Previously diagnosed Type II Diabetes patients having Fasting blood sugar more than 110 mg/dl Postprandial more than 140 mg/dl Random blood sugar 180 mg/dl HbA1C more than 7 with peripheral neuropathy(Sensory).
排除标准
- •Type I Diabetes mellitus Diabetes Insipidus Gestational Diabetes mellitus Chronic Kidney diseases having S Creatinine more than 2 mg/dl Motor neuron disease Presence of foot ulcer Myopathy.
结局指标
主要结局
During treatment or after treatment reduction of following symptoms
时间窗: 90 days
HbA1C below 6mg/dl
时间窗: 90 days
Reduction in numbness in the limbs
时间窗: 90 days
Glucose level within normal limit
时间窗: 90 days
reduction in general tiredness,malaise.
时间窗: 90 days
次要结局
- Evaluation of physicochemical,phytochemical,pharmacological activities of Alli Chooranam.(Evaluation of Siddha parameters (including Envagai thervu) in Kapha Neerizhivu during trial period.)