A Randomized, Double Blind, Placebo Controlled, Single Centric, 2 Arm Clinical Trial to Assess the Efficacy and Safety of Amrith Noni D Plus in Patients with Type II Diabetes Mellitus who are on OHA. - VAL_SCRS_DM_2022

Valyou products private limited0 个研究点目标入组 30 人开始时间: 待定最近更新: 2022年11月21日

试验速览

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•1. Antiplatelet, ACE Inhibitors, ARBs, Lipid lowering drug.
•2. NASIDS (prolonged use for more than 10 days).
•3. Any herbal supplement/ drug.
•4. Blood pressure: BP >160/100 mmHg.
•5. Any clinical history of cardiovascular disease, Liver, hormonal
•disorder or treatment or kidney disease.
•6. History of peptic ulcer disease and/or GI. bleeding/perforation
•7. History of cancer.
•8. History or presence of proliferative retinopathy, severe nonï¿¾proliferative retinopathy, macular edema or presence of
•untreated diabetic eye disease.
•9. History of treated peripheral or autonomic neuropathy.
•10. Pregnant or lactating females or absence of effective
•contraceptive methods for females of childbearing potential.
•11. Presence of any severe medical or psychological condition or
•chronic condition/inflammation/infection that in the opinion of
•the investigator would compromise the patientâ??s safety or
•successful participation in the study.
•12. Participation in any other clinical study within 30 days of
•13. Systemic long-acting corticosteroids (prolonged use for more
•than 10 days) or immunosuppressants.
•14. History of allergy to any of the drugs / investigational products.
•15. History of chronic alcoholism.
•16. Planned surgical intervention during the expected study

发起方

Valyou products private limited