Evaluation of anti-diabetic efficacy of four selected classical Ayurvedic poly-herbal formulations in Type-2 Diabetes Mellitus-A randomized pilot study - Pilot RCT-4 formulations

Ministry of AYUSH Govt of India0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1.Subjects of either sex, 18-70 years
•2.Freshly diagnosed or known diabetic subjects with HbA1c of 7-9% (both values included).
•3.Subjects who are drug naive or on any OHA
•4.Subjects who agree to participate in the study and submit a written informed consent form

•1.Subject diagnosed with type 1 Diabetes Mellitus.
•2.Subjects who are on Insulin therapy
•3.Subjects with Haemoglobin percentage < 8 g/dl.
•4.Subjects with uncontrolled hypertension (with or without medication systolic >150 and/or diastolic >100 mmHg after 10 minutes of rest)
•5.Subjects with established diagnosis of CAD or any other clinically significant cardiovascular disease.
•6.Subjects with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit)
•7.Renal Dysfunction (defined as Egfr < 60 ml/min. calculated by MDRD eGFR calculator)
•8.Uncontrolled acute Pulmonary Dysfunction requiring inhalation or systemic steroids.
•9.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.
•10.Pregnant / Lactating women.
•11.Subject on systemic or oral steroids, oral contraceptive pills or estrogens replacement therapy.
•12.Subjects with current diagnosis of malignancy or in last five years.
•13.Subjects suffering from major systemic illness necessitating long term drug treatment (defined as more than 3 months).
•14.Subjects who have completed participation in any other clinical trial during the past three months.
•15.Any other condition which the Investigator thinks may jeopardize the safety of the subject.

发起方

Ministry of AYUSH Govt of India