To determine safety and efficacy of Food Supplement in patients with type-2 diabetes mellitus in addition to the standard treatment.

Efficacy of food supplement formulation in type 2 diabetes mellites in terms of HbA1c and quality of life. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061974

Enrollment

150

Registered

2024-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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: InshuNourish: Sachet of 5 gm of powder InshuNourish will be given twice a day. This contains following ingredients in it: Syzyguim cumini, Curcuma longa, Cinnamomum verum, Azhadiracta

Eligibility

Inclusion criteria

Inclusion criteria: 1. Attending clinic / hospital for managing type 2 diabetes mellitus with HbA1c 6.5% or more. 2. There is no change in oral hypoglycemic regimen for at least three months. 3. Patient of any gender between age 35 and 65 years . 4. Patients willing to consent in writing.

Exclusion criteria

Exclusion criteria: Pregnant and lactating mothers and women intending to become pregnant Diabetes other than type 2 diabetes mellitus Patients having complications of diabetes like diabetic neuropathy, retinopathy, nephropathy, ketoacidosis Participation in any other clinical trial within the last 30 days Patients with acute infection, any uncontrolled systemic illness or any cancer Patients with life expectancy less than 12 months

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of formulated food supplement in terms of HbA1c levels in experimental group Timepoint: 90 days	—

Secondary

Measure	Time frame
To assess the effect of Food Supplement on Quality of life of T2DM patients pre and post intervention in experimental and control group Timepoint: 1(±4 days), 30th day (±4 days),60th day,90th day (±4 days)	—

Countries

India

Contacts

Public ContactMs Ruchu Kuthiala

Dr D Y Patil College of Ayurved and Research Centre

clinicalnutruchu@gmail.com8805019180

Outcome results

None listed

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