Pre Clinical and Clinical Evaluation of Safety And Effectiveness of Siddha Formulation Thiripalathi Kashayam in the Management of Madhumegam (Type II Diabetes Mellitus)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. To test the hypothesis that the study drug produces a decrease of 5mmol/mol (equivalent to 0.5%) change in Plasma HbA1c
研究概览
简要总结
Title of clinical Study:Clinical evaluation of safety and effectiveness****of siddha formulation Thiripalathi Kashayam in****the management of Madhumegam (Type II Diabetes mellitus)
STUDY DESIGN:
Open labelled single centric phase II clinical study with Siddha herbal formulation Thiripalathi Kashayam will be conducted in 40 Madhumegam (Type II Diabetes mellitus) patients.
Study drug dosage: 45 ml 5minutes before food twice a day
Duration of study drug administration: 120 days
STUDY PLACE: OPD and IPD of Ayothidoss Pandithar Hospital
National Institute of Siddha, Tambaram sanitorium, Chennai-47
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
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Adult men / women / transgender 35 years – 60 years of age.
- •2 Type II Diabetes mellitus (According to American Diabetes Association criteria 2023) 3 If yes, any one of the three (40) a FBS ≥ 126 mg/dl b PPBS ≥ 200 mg/dl c HbA1C ≥ 7 ≤ 10% 4 Patients who didn’t take medicines for Diabetes at least for the past three months and are willing to take study medication alone.
排除标准
- •Age below 35 and above 60 yrs HbA1C less than 7 and more than 10 Pregnancy and breastfeeding.
结局指标
主要结局
1. To test the hypothesis that the study drug produces a decrease of 5mmol/mol (equivalent to 0.5%) change in Plasma HbA1c
时间窗: Baseline and after 4 months
次要结局
- 1. To test the proportion of patients achieving(• Serum fasting glucose [≤ 126 mg/dl] & 2 hr postprandial glucose [≤ 200 mg/dl])
研究者
Dr Janani Syamaroopa Jnanathapaswini
National Institute of Siddha Tambaram Sanatorium Chennai