CTRI/2022/04/042289尚未招募2 期
An Interventional, Single Centre, Open Label, Single Arm Trial To Study The Safety And Efficacy Of Madhumeha Kusumakar Rasa In Type 2 Diabetes Mellitus.
MS Shree Dhootapapeshwar Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Confirmed diagnosis of Type II Diabetes Mellitus by HbA1c >=6.5% and <=8%.
- •2.Patients of either sex in the age group of 18-50years (Age >=18 and <= 50 years)
- •3.BMI up to 35.0 kg/m2
- •Women of child-bearing potential (Defined as all women physiologically capable of becoming pregnant, must use hormonal contraception) and Postmenopausal status / undergone tubal ligation / undergone hysterectomy.
排除标准
- •1.Known hypersensitivity to Madhumeha Kusumakar Rasa or any of its components.
- •2.Evidence of pregnancy (Any one of Positive UPT, USG evidence produced by the patient or bearing a prescription with clinical diagnosis of pregnancy).
- •3.Participation in another trial or receipt of any investigational medicinal product within 90 days prior to Screening Visit.
- •4.History of episode of level 3 hypoglycemia or elicitable history of recurrent hypoglycemia as judged by the Investigator.
- •5.Type I Diabetes Mellitus or Secondary Diabetes.
- •6.History of acute metabolic complications of Diabetes within 3 months prior to Screening Visit.
- •7.History of any of the following in past 3 months: Episode of unstable angina, Acute Coronary Syndrome, or another significant cardiovascular event.
- •8.Uncontrolled treated or untreated hypertension.
- •9.Renal impairment (eGFR <60ml/min/1.73m2).
- •10.Hepatic impairment ( >3 times Upper limit of normal (UNL) of AST/ALT)
- •11.Known intake of opioids or abuse of alcohol or suspected abuse of alcohol.
- •12.History of chronic pancreatitis or idiopathic acute pancreatitis.
- •13.Any history of or diagnosis / treatment of any form of cancer within last 5 years.
- •14.Any history of severe neuropathy which prevents patient from complying with study procedures
- •15.Patient on medication that may promote hyperglycemia (e.g., Steroid)
- •16.Mental incapacity, which means those who cannot take decisions.
- •Patients treated with anti-obesity medications belonging to modern medicines.
研究者
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