A Prospective Open Labelled ,Non-randomised,Phase-II clinical trial of ATHTHIKKAI CHOORANAM in the management of MADHUMEGA AVATHAIGAL I-V(DIABETES MELLITUS & ITS COMPLICATIONS)
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
- 2.Reduction of the sign and symptoms mentioned in inclusion criteria
研究概览
简要总结
The study is a prospective open labelled, non-randomised ,phase II clinical trial to determine the efficacy and safety of ATHTHIKKAI CHOORANAM in patients with MADHUMEGA AVATHAIGAL I-V(DIABETES MELLITUS AND ITS COMPLICATIONS).The trial drug is processed from unripened fruits of FICUS RACEMOSA. In this clinical trial to be held at GSMC,Palayamkottai 60 patients (30 in OPD +30 in IPD) will be recruited and the trial drug will be administered at the dose of 72 mg/Kg/BW BD B/F along with buttermilk as adjuvant for a period of 90 days.All the study related data will be recorded and documented in a separate file for each patients.In case of any adverse event (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patient will be given in OPD,GSMC Palayamkottai. During this trial all the efficacy and safety parameters will be recorded in the CRF. After completion of trial all the study related data will be analysed statistically.
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
- 35.00 Year(s) 至 69.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Type II DM patients who were previously diagnosed and having uncontrolled or poorly controlled for more than 2 years duration of illness.
- •2.Even if patient is having any one amo ng the three a.FBS more than 126mg/dl and within 250mg/dl or b.PPBS more than 200mg/dl and within 350mg/dl or c.HbA1c more than 6.5 and within 10 3.Patients with symptoms of polyuria,polydipsia,polyphagia,asthenia,obedsity(mdetabolic syndrome),numbness,tingling sensation, mood changes and irritability,difficulty in concentration 4.Patients willing to give blood and urine sample before and after the treatment.
- •5.Willing to participate in study and signing consent by fulfilling the condition of proforma.
排除标准
- •1.Type I DM 2.Gestational DM 3.Other specific types of DM 4.Diabetes insipidus 5.Pregnancy 6.Lactating mother 7.Chronic kidney disease 8.Chronic liver disease 9.Ischemic heart disease 10.Other types of neuropathy.
结局指标
主要结局
2.Reduction of the sign and symptoms mentioned in inclusion criteria
时间窗: 90 days
1.To bring the values of FBS less than 126mg/dl PPBS to less than 200mg/dl and HbA1c to less than 6.5
时间窗: 90 days
次要结局
- 1.Achieving of optimal BMI(2.Achievin g of optimal blood pressure)