To determine safety and efficacy of Cap. Hintosulin in drug naïve pre-diabetics and in Type-2 Diabetic patients on OHA

Completed

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2019/09/021126
• Lead Sponsor: Ishaana Nutraceutical Pvt Ltd

Brief Summary

This is a prospective, open labelled, double arm, multi centric study, which will assess safety and efficacy of Cap. Hintosulin in reducing blood sugar levels. A total of 50 patients will be enrolled in the study (25 pre-diabetic and 25 known diabetic). 25 patients’ retrospective data of OHA dependent Type-2Diabetes patients will be collected as a retrospective control group. Patients enrolled in the study (prospective cohort) will get the Investigational Product (IP), which is, Cap. Hintosulin, with dose of 1 capsule two times daily for 90 days. Patients will undergo routine checkup and laboratory investigations. Blood sugar levels will be done during each scheduled visit, whereas HbA1c, renal function tests, liver function tests, hemogram will be done during enrollment and last (90 day) visit.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-09
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Subject having BSL (F) between 100 and 125 and is not a known diabeticOR subject is a known case of T2DM and is on oral anti-diabetic treatment 2.No change in anti-diabetic treatment for the last one month if not detected DM in last month 3.Between Age group of 18 and 70 years 4.Both male and female patients will be included.

Exclusion Criteria

• 1.Diabetes other than type 2 diabetes mellitus 2.Patients having complications of diabetes like diabetic neuropathy, retinopathy, nephropathy, ketoacidosis.
• 3.Participation in any other clinical trial within the last 30 days 4.Pregnant or breast-feeding woman.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of Cap. Hintosulin for management of blood sugar levels in drug naïve pre diabetics and and in Type-2 Diabetic patients	Day 15, 30, 60 and 90

Secondary Outcome Measures

Name	Time	Method
To assess efficacy of Cap. Hintosulin in delaying oral hypoglycemic agents (OHA) in drug naïve pre diabetic patients.	To access efficacy of Cap. Hintosulin in OHA dependent T2DM patients inmodifying OHA and / or its dose.

Trial Locations

Locations (3)

Devgiri Diabetic center; 🇮🇳 Aurangabad, MAHARASHTRA, India

Karnawat Superspecialty clinic; 🇮🇳 Nashik, MAHARASHTRA, India

Suryaprabha Nursing Home; 🇮🇳 Pune, MAHARASHTRA, India

Devgiri Diabetic center

🇮🇳Aurangabad, MAHARASHTRA, India

Dr Deepak Bhosale

Principal investigator

7770087870

drdeepakbhosle@gmail.com