A study to Evaluate the Safety and Efficacy of Herbal /Nutraceutical Oral Capsule and Herbal / Nutraceutical Rectal Medication Combination in Improving the Gut Health of Patients with Type 2 Diabetes Having Chronic Kidney Disease (CKD).

Completed

• Conditions: Type 2 diabetes mellitus with kidney complications. Ayurveda Condition: Type 2 diabetes with CKD,

• Registration Number: CTRI/2022/04/042052
• Lead Sponsor: Arogyaseva Medical Academy of India AMAI

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-05
• Study Completion: 2023-07-21
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
i. Change in Abdominal pain scale from baseline to end of the treatment.	Baseline to end of the treatment.
ii. Average scores of gastrointestinal symptoms by questionnaire from	Baseline to end of the treatment.
baseline to end of the treatment.	Baseline to end of the treatment.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Bhate Hospital; 🇮🇳 Belgaum, KARNATAKA, India

Parth Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Saikrupa Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Signus Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Bhate Hospital

🇮🇳Belgaum, KARNATAKA, India

Dr Amit Bhate

Principal investigator

8197940086

amitbhate85@gmail.com