A Comparative Study on the effect of the Avaraiyathi Chooranam and Madhumega Chooranam in the management of Madhumegam (Diabetes Mellitus -Type II) – An Open label, Randomized controlled trial in patients reporting at Ayothidoss Pandithar Hospital, National Institute of Siddha.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
Type II Diabetes mellitus participants will be screened. Participants will be informed about the objective of the study. Complete clinical history, complaints and duration, examination findings all will be recorded. Study participants will be allocated in to group “A” and group “M” by Randomization. Blood investigations (FBS & PPBS) will be done at base line, 30th day, 60th day and 90th day. HbA1c, HOMA IR (for sub group, every 5th person of each group) will be checked on base line and 90th day. The participants will be given study drug Avaraiyathi Chooranam and Madhumega Chooranam 15 days once for a period of 90 days. All enrolled participants will be recommended to follow the diet chart and advised not to take any other anti-diabetic drugs during the study period of 3 months. Base line and at the end of 3 months along with blood sugar, lipid profile, hematology, renal and liver function test will be performed. After completion of study patient can follow with OPD medicines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Glycosylated Hemoglobin (HbA1c) More than 6.5 percent and Less than 9 percent Newly diagnosed type II diabetes mellitus patients.
排除标准
- •Participants of Type-I DM (insulin dependent DM) or Type-II DM on insulin Participants with current diagnosis of malignancy Participants suffering from major systemic illness necessitating long term drug treatment (TB, AIDS) Pregnant and Lactating women Participants who have participation in any other clinical trial.
研究者
HITHA SHYAM MS
National Institute of Siddha