Efficacy and safety of Targlut add-on therapy in prediabetes and type2 diabetes mellitus: A randomized double-blind placebo-controlledtrial

Composite Interceptive Med Science Laboratories Pvt. Ltd,0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年3月6日

试验速览

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•Adults of age 30 years and above (either gender) with a diagnosis of prediabetes or diabetes mellitus (on stable dose for 3 months) satisfying one or more of the American Diabetes Association (ADA) criteria and willing to provide written informed consent.

•1. Patients with HbA1c > 10 or blood sugar level > 300 mg/dl
•2. Current use of insulin (if administered previously, there should be a gap of at least 3 months)
•3. History of stroke. MI or any revascularization procedure within
•the last 3 months
•4. NYHA class III or IV
•5. Pregnant and lactating women or planning to become pregnant
•in the next 12 weeks
•6. Current daily use of any supplement containing the herbs in the study supplement
•7. Patients with history of thyroid disorder or any other endocrine disorder that can affect blood sugar level or patient participation
•8. Drugs that can increase blood sugar level such as corticosteroids
•9. Impaired renal function (eGFR <90 mL/min/1.73 m2)
•10. Abnormal liver enzymes (more than 2 times the upper limit of normal)
•11. Patients diagnosed with malignancy
•12. Patients with diagnosis of psychiatric illness or addiction
•13. Patients with history of autoimmune disease or immune compromising disease including HIV/AIDS
•14. Any other condition which on the opinion of the study investigator makes the patient ineligible

发起方

Composite Interceptive Med Science Laboratories Pvt. Ltd,