CTRI/2024/03/064184尚未招募2 期
Safety and efficacy of Mustadi ghanavati and Varadi ghanavati in Madhumeha / Type-2 Diabetes Mellitus : An open labelled randomized controlled active comparator (Metformin) Phase II study - NI
Ayurswasthya Yojana, Centre of excellence Scheme, Ministry of Ayush, Govt of India0 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
- •i.Subjects of either sex aged between 18-70 years.
- •ii.Newly diagnosed or drug naïve (in the preceding 3 months) known subjects of diabetes with HbA1c 7-9.0 % (both values inclusive)
- •iii.Subjects who submit a written informed consent form.
排除标准
- •i.Subject diagnosed with type 1 Diabetes Mellitus.
- •ii.Subjects with Type-2 Diabetes who are on any type of Anti-hyperglycemic agents in the past 3 months
- •iii.Subjects with Haemoglobin percentage less than 10 g/dl
- •iv.Subjects with uncontrolled hypertension (with or without medication more than 160/100 mmHg after 10 minutes of rest)
- •v.Subjects with recent (less than 6 months) acute coronary syndrome, PTCA, CABG, CVA or any other major acute Cardiovascular event or intervention
- •vi.Subjects with recent (less than 6 months) major surgical procedure
- •vii.Subjects with concurrent Hepatic Dysfunction (defined as AST and/or ALT more than 3 times of the upper normal limit)
- •viii.Subjects with Renal Dysfunction (defined as eGFR less than 60 ml/min. calculated by CKD-EPI eGFR calculator 2021)
- •ix.Subjects with Hypothyroidism or Hyperthyroidism currently not euthyroid on therapy
- •x.Uncontrolled acute Pulmonary Dysfunction requiring inhalation or systemic steroids
- •xi.Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy
- •xii.Pregnant / Lactating women
- •xiii.Subject on systemic or oral steroids, oral contraceptive pills or estrogen replacement therapy
- •xiv.Subjects with current diagnosis of malignancy or in last five years
- •xv.Subjects suffering from major systemic illness necessitating long term drug treatment (defined as more than 3 months)
- •xvi.Subjects who have completed participation in any other clinical trial during the past three months
- •xvii.Any other condition which the Investigator thinks may jeopardize the safety of the subject.
研究者
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