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

Two arm, prospective study to determine safety and efficacy of Cap. Hintosulin in drug naïve pre-diabetics and in Type-2 Diabetic patients on OHA in decreasing blood sugar levels. - HinQuest-DM01

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021126
Enrollment
50
Registered
2019-09-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Cap. Hintosulin: Dose-1 capsule Frequency- twice a day Duration- 90 Days Route-Oral It is a nutraceutical product, food for special dietary use Control Intervention1: Cap. Hintosulin

Sponsors

Ishaana Nutraceutical Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of Cap. Hintosulin for management of blood sugar levels in drug naïve pre diabetics and and in Type-2 Diabetic patientsTimepoint: Day 15, 30, 60 and 90—

Secondary

MeasureTime frame
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. To access safety of Cap. Hintosulin in drug naïve pre-diabetics and in T2DM patients in terms of reported Adverse eventsTimepoint: Day 15, 30, 60 and 90—

Countries

India

Contacts

Public ContactDr Sharvari Rangnekar

Quest Clinical Services

questclinicalservices@gmail.com9890229919

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026