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clinical study of investigational product (GSH/Nut/M009) in early-stage cardiometabolic disorders

A randomized, double blind, two dose clinical study to assess efficacy of investigational product (GSH/Nut/M009) in individuals with early-stage cardiometabolic disorders - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108316
Enrollment
60
Registered
2026-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: E749- Disorder of carbohydrate metabolism, unspecified

Interventions

None listed

Sponsors

Hirehal Greenspace Herbs Pvt. Ltd.,
Lead Sponsor
Pharma Instinct Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Adults between 18 to 65 years of age of both sexes. Subjects with recent onset (less than 1 year) of Hypertension, BP more than 130 systolic 85 diastolic mm per Hg, T2DM, FBS 100 to 125mg per dL and Hypertriglyceridemia i.e. Fasting TGL more than 150 mg per dL Waist circumference, Male more than 40 inches and Female more than 35 inches Not currently receiving pharmacological treatment, including, No statins or lipid-lowering medications, No antihypertensive medications, No antidiabetic medications or insulin, Currently managed with diet and lifestyle modifications only, with no prior or ongoing use of standard-of-care drugs for these conditions. Willing to provide informed consent and comply with study procedures and follow-up visits.

Exclusion criteria

Exclusion criteria: Use of statins or any lipid-lowering agents within the last 3 months Use of antihypertensive medications Use of antidiabetic medications, including oral hypoglycemics or insulin Use of corticosteroids or hormonal therapies known to influence metabolic parameters Established cardiovascular disease (e.g., MI, stroke, angina, or other surgical or non-surgical CVD) Chronic kidney disease and significant hepatic impairment Pregnant and lactating women Active smokers or individuals with alcohol dependence

Design outcomes

Primary

MeasureTime frame
Fasting blood sugar HbA1C Lipid profileTimepoint: Baseline 8 weeks 12 weeks

Secondary

MeasureTime frame
Waist circumference BP MAP Hb TLC DLC Liver function test Renal function test QOL SOD GSH MDA Apolipoprotein A1 Apolipoprotein B Apolipoprotein B/ApolipoproteinTimepoint: Baseline 12 weeks

Countries

India

Contacts

Public ContactDr Danish Javed

All India Institute of Medical Sciences Bhopal

danish.ayush@aiimsbhopal.edu.in09654978285

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026