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).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- i. Change in Abdominal pain scale from baseline to end of the treatment.
研究概览
简要总结
A prospective, randomized, openlabel, parallel group, comparative clinical trial to evaluate the safety andefficacy of Ayurvedic oral capsule and Ayurvedic anal oil combination (anayurvedic formulation) in improving the gut health of patients receivingstandard of care treatment for type2 diabetes having chronic kidney disease(CKD). This trial is designed to asses the safety and efficacy of an Ayurvedic capsule to improve the Gut health of Type 2 diabetes patients with CKD disease.
Total 90 patients will be randomized in 1: 1 ratio, 45 patients in each arm. One group will receive Ayurvedic capsule + SOC and remaining patients will receive only SOC as per randomization number assigned to each eligible patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
- •viii.Patients with hypersensitivity to any of the ingredients of the study products.
结局指标
主要结局
i. Change in Abdominal pain scale from baseline to end of the treatment.
时间窗: Baseline to end of the treatment.
ii. Average scores of gastrointestinal symptoms by questionnaire from
时间窗: Baseline to end of the treatment.
baseline to end of the treatment.
时间窗: Baseline to end of the treatment.
次要结局
- i. Changes or % incidence of adverse events, laboratory test results, vital signs between the groups from their screening visit to end of treatment.(ii. Percentage (%) change in the TNF alpha ILF, IL8 between the groups from their screening visit to end of treatment.)