A Prospective, open labelled, single arm, non randomized, single centric, phase II, Clinical trail to determine the effectiveness of Pathiriver chooranam in the management of Madhumega Noi(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
- The outcome will be aimed at reducing symptoms of Diabetes mellitus and to determine the therapeutic efficacy of Pathiriver chooranam
研究概览
简要总结
This is A Prospective, open labelled, single arm,non randomized, single centric, phase II, Clinical trail to determine the effectiveness of Pathiriver chooranam in the management of Madhumega Noi( DiabetesMellitus). Pathiri ver chooranam will be freshly prepared and administered at a dosage of 1 to 2 gms (Twice a day orally) with hot water as adjuvant for 3 months for 40 patients of Diabetes mellitus ( 20 OP AND 20 IP patients). The primary outcome will be to develop evidence support for the effect of Pathiriver chooranam in the management of Madhumegam (Diabetes Mellitus ). The secondary outcome will be to collect various siddha literatures and modern journals, to evaluate Physio Chemical, Phyto Chemical, Bio Chemical analysis, to study the anti-microbial activity for selected micro-organism, to evaluate Pharmacological activities, to evaluate safety profile for acute and sub-acute toxicity, to evaluate modern parametric changes in Madhumegam, to evaluate the cell line study of anti-diabetic activity, to evaluate siddha parameters and compare the changes in Madhumegam during trial period.
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 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Even if patient is having any one among the three (WHO criteria 2019): a.
- •FBS above 126 mg/dl and below 250mg/dl or b.
- •PPBS above 200mg/dl and below 350mg /dl or c.
- •HbA1c above 6.5 and below 10
- •Patients with symptoms of polyuria, polydipsia , polyphagia, asthenia, nocturia,obesity ( metabolic syndrome) , numbness, tingling sensation, mood changes and irritability, difficulty in concentration.
排除标准
- •1.Age below above 34 years and below 60 years 2.Type 1 diabetes mellitus 3.Gestational DM 4.Diabetes insipidus 5.Pregnancy 6.Lactating mother 7.Chronic kidney disease 8.Chronic lever disease 9.Ischemic heart diseases.
结局指标
主要结局
The outcome will be aimed at reducing symptoms of Diabetes mellitus and to determine the therapeutic efficacy of Pathiriver chooranam
时间窗: 3 months
次要结局
- 1.To collect various siddha literatures and modern journals.(2.To evaluate Physio Chemical, Phyto Chemical, Bio Chemical analysis.)
研究者
ABINAYA T
Government Siddha Medical College and Hospital