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A clinical study to find the efficacy and safety of Diacare in patients with type 2 diabetes mellitus

An open labeled clinical trial to evaluate efficacy and safety of Diacare in patients with type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/11/003119
Enrollment
100
Registered
2012-11-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Diacare herbal powder: Take approx. 5 gms. (1 tea spoon) powder, mix it with 1 glass of water (Approx. 200 ml.) stir it properly and kept it overnight. Drink the water on empty stomach

Sponsors

Admark Herbals Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Aged 30 to 65 years • Male and female patients with Type 2 diabetes • Patients with inadequate glucose control on any anti diabetic drugs • Body mass index between 20-35 kg/m2 • Having fasting blood glucose > 126 mg/dL • Post prandial blood glucose > 200 mg/dL • Having no serious physical or biochemical abnormalities other than those generally associated with type 2 diabetes and who are willing to give written informed consent

Exclusion criteria

Exclusion criteria: • Patients having diabetes other than non insulin dependent diabetes mellitus • Having history of hypersensitivity, liver or kidney damage or gastrointestinal disorders, acute infections, diseases of blood or hematopoietic organs • Pregnant or lactating women and patients receiving any concomitant medication, which may have interacted with hypoglycemic action of study drug • Previous participation in a clinical trial in the last 6 months.

Design outcomes

Primary

MeasureTime frame
â?¢ Reduction in plasma glucose levels (fasting and post prandial glucose) â?¢ Reduction in HbA1c level (glycosylated hemoglobin) as compared with baseline Timepoint: 3 months At day 21, 45 and day 90

Secondary

MeasureTime frame
â?¢ Incidence of any related adverse effects â?¢ Vital signs and physical examinations (pulse rate, blood pressure, weight) â?¢ Selected biochemistry and hematology parameters at baseline and after treatment Timepoint: 3 months At baseline and day 90

Countries

India

Contacts

Public ContactDr Divya Dutt

ICBio Clinical Research Pvt. Ltd.

vikram.baburao@icbiocro.com9900111993

Outcome results

None listed

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