CTRI/2024/04/065722招募中2 期
A Prospective, Double Blind, Randomized, Parallel, Two-Arm, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of Rasayanam Gluco-Care in subjects with Type 2 Diabetes Mellitus - NI
Rasayanam Enterprises0 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
- 招募中
- 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.Able to provide written informed consent and adhere to the study visit schedule and treatment. 2.Diagnosed with Type 2 diabetes mellitus and stable on routine medication. 3.Male or female aged 18 to 70 yrs of age. 4.Women of child bearing potential or WOCBP must be willing to use double barrier contraception for the entire study. 5.WOCBP must have a negative pregnancy test before entering the study. 6.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form. 7.Participants who agree to take investigational product
排除标准
- •1.History of insulin use for more than 2 weeks within 2 months prior to the Screening Visit
- •2.Subjects after bariatric surgery or any gastric bypass or planning to have such a procedure during the Study
- •3.History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, peripheral arterial event or any revascularization procedure during the 6 months prior to the Screening Visit or planned vascular procedures or surgery during study period
- •4.History of congestive heart failure
- •5.Any history of a malignancy
- •6.Pregnancy or breast-feeding, or intent to become pregnant during the study period
- •7.Known infection with human immunodeficiency virus
- •8.Any condition, laboratory abnormality, or concomitant therapy which, in the opinion of the Investigator, might pose a risk to the subject or make participation not in the subject’s best interest
- •9.Diagnosis of cancer.
- •10.History or presence of any medical conditions which impacts the quality of life
- •11.Hypersensitivity to product or placebo
- •12.Use of prescription medications and non-prescription medications for weight loss
- •13.Current diagnosis or medical history of alcoholism and drug dependence
- •14.Use of medications that are prohibited with the herbal products as per investigator descretion
- •15.Any other condition which the principal investigator thinks may jeopardize the safety of subjects with uncontrolled, unstable comorbidities
- •16. Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational study or is receiving other investigational agents.
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