AN OPEN LABELLED DOUBLE ARM NON RANDOMIZED PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY OF KEEZHKAI NELLI PODI AND KEEZHKAI NELLI PODI WITH SIDDHAR YOGA MARUTHUVA MURAIGAL IN THE MANAGEMENT OF MADHUMEGAM (TYPE II DIABETES MELLITUS)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- This study outcome is regulate the blood sugar level
研究概览
简要总结
This study is an open labelled double armed non-randomized phase II clinical trial to evaluate the efficacy of KEEZHKAI NELLI PODI AND SIDDHAR YOGA MURAIGAL in the management of
MADHUMEGAM (TYPE II DIABETES MELLITUS)The study contain 2 groups and divided into Group I is Keezhkai nelli podi internally and Group II is Keezhkai nelli podi internally along with siddhar yoga Muraigal. Each group contain 20 patients and duration 48 days.The study period is 24 months will be
carried out in Government siddha medical College and hospital, Palayamkottai, Tirunelveli 627002, Tamilnadu.The outcome will be a positive impact of yoga therapy and medicine in the management of Madhumegam (Type II Diabetes mellitus).In case of any
adverse events (AE) is noticed and it will be referred to pharmacovigilence department of Further management of patients will be given OPD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of Non Insulin Dependent Diabetes Mellitus with symptoms of Polyuria Polydipsia Nocturia Polyphagia Blood glucose level FBS greater than 126 mg/dl smaller than and equivalent to 250 mg /dl PPBS greater than 200 mg/dl lesser than equivalent to 350 mg/dl HbA1C greater than 6.5 lesser than and equivalent to 8.Willing to participate in Study and signing consent by fulfilling the condition of Proforma.Patient willing to give blood and urine sample before and after the treatment.
排除标准
- •Patient with diabetic complications Diabetic foot Nephropathy Neuropathy and Retinopathy Insulin Dependent Diabetes Mellitus .Any other serious Systemic illness.
- •Pregnancy and lactation.
结局指标
主要结局
This study outcome is regulate the blood sugar level
时间窗: 48 days
次要结局
- The positive impact of yoga in the treatment(aspect may be highlighted through this study.)