Study on Nutritional Supplement for Diabetic Patients.

Phase 3

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2022/08/045041
• Lead Sponsor: ichiIn Bio Sciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Adults between the ages of 18 of 65 years (both ages and all genders inclusive)

2.Subjects with history of Diabetes Mellitus Type II (as defined by ADA) treated only by OHA and/or Insulin

3.Subjects who are non-alcoholic and non-smokers/non-users of tobacco.

4.Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.

5.Subjects who are willing not to participate in any other clinical trial during participation in the current trial

Exclusion Criteria

1.Subjects with allergy, sensitivity or intolerance to the study drugs and their formulation ingredients

2.Subjects who are taking other dietary supplements

3.Subjects who are on regular probiotic or prebiotic intake (more than 2 months)

4.Subjects with Organic insufficiencies (cardiac, hepatic, renal, respiratory), or with immunodeficiencies (HIV, chemotherapy, radiotherapy, transplanted).

5.Subjects with Acute and / or chronic intestinal pathologies (malabsorption syndrome, celiac disease, chronic inflammatory bowel diseases, among others.)

6.Subjects who have participated in any clinical study within 3 months from the date of enrolment.

7.Females who are pregnant or lactating or planning to become pregnant during the study period.

8.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.

9.Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified