A Prospective, Randomized, Open label, Parallel group, Comparative Clinical Trial to Evaluate the Safety and Efficacy of Herbal / Nutraceutical Oral Capsule and Herbal / Nutraceutical Rectal Medication Combination in Improving the Gut Health of Patients Receiving Standard of Care Treatment for Type 2 Diabetes Having Chronic Kidney Disease (CKD).

Arogyaseva Medical Academy of India AMAI0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年5月27日

试验速览

暂无简介。

•i.Adult male and non-pregnant females aged 18 to 65 years
•ii.Patients who have weak gut health characterized by either constipation or diarrhea (more than 2 episodes per day in the past 5 days)
•iii.Patients who are diabetic with CKD non-dialysis will be considered in the study.
•iv.Able to comply with all required study procedures and schedule.
•v.Able to comply and willing to follow the prescribed diet plan.
•vi.Willing and able to give written informed consent.

•i.Patient on antibiotics or vitamin supplement (except vitamin D analogs) in the last three months.
•ii.Advanced liver disease, advanced cardiovascular disease, heart failure with EF < 30%, and autoimmune disease.
•iii.The use of chemotherapy, antibiotics, immunosuppressive medications, probiotics, and steroid in the last three month.
•iv.Intravenous or oral iron supplementation, laxatives, and kayexalate in the last month.
•v.History of intra-abdominal surgery, small or large intestine resection or small bowel obstruction.
•vi.History of colon cancer or gastrointestinal bleed.
•vii.Patient who has participated in a clinical study within the last 30 days prior to entering this study.
•viii.Patients with hypersensitivity to any of the ingredients of the study products.
•ix.Patients who are taking immunosuppressive therapy.

发起方

Arogyaseva Medical Academy of India AMAI