A Prospective Open Labelled, Single Arm, Non- Randomized, Single Centric, Phase II Clinical Trail To Determine The Effectiveness Of Nelliyathy Kashayam 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
- If during treatment or after treatment FBS became below 126 mg dl & PPBS below 200 mg dl and HbA1c below 6.5
研究概览
简要总结
This study is a Prospective Open Labelled, Single arm, Non-Randomized, Single centric, Phase II Clinical trial to determine the Effectiveness of NELLIYATHY KASHAYAM in the management of MADHUMEGA NOI (DIABETES MELLITUS). The trial drug will be administered at the dose of 1-2 gram twice a day 90 days in 40 patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli 627002 , Tamil nadu. The primary outcome will be the evaluation of therapeutic efficacy of the trial drug NELLIYATHY KASHAYAM. The secondary outcome will be the evaluation of Siddha diagnostic parameters, Assessment of pharmacological and biochemical parameters of the trial drug. In case of any adverse events(AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients Will be given in OPD facility.
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 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Even if patient is having any one among the three (WHO criteria 2019): FBS.
- •above126 mg/dl and below 250mg/dl or PPBS.
- •above 200mg/dl and below 350mg /dl or HbA1c 6.5 to 10 Patients with symptoms of polyuria, polydipsia, polyphagia,asthenia,nocturia,obesity (metabolic syndrome),numbness, tingling sensation.
排除标准
- •Type 1 diabetes mellitus Gestational DM Diabetes insipidus Pregnancy Lactating mother Chronic kidney disease Chronic lever disease Ischemic heart diseases.
结局指标
主要结局
If during treatment or after treatment FBS became below 126 mg dl & PPBS below 200 mg dl and HbA1c below 6.5
时间窗: 90 days
次要结局
- Reduction of the sign and symptoms of polyuria, polydipsia, polyphagia, asthenia, nocturia, numbness, tingling sensation, nausea, mood changes and irritability, difficulty in concentration(90 days)