A study to investigate the blood sugar lowering effect of EN-DM-02, EN-DM-04 and EN-DM-05 in comparison with placebo in drug naïve/medication free patients with Type II Diabetes Mellitus under Protocol ID: VL/090707/EN/DM/EN-DM-05.

An exploratory, randomized, double blind, parallel, placebo controlled study to investigate the blood sugar lowering effect of EN-DM-02, EN-DM-04 and EN-DM-05 in comparison with placebo in drug naïve/medication free patients with Type II Diabetes Mellitus under Protocol ID: VL/090707/EN/DM/EN-DM-05.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/09/001996

Enrollment

Registered

2011-09-09

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: null- Drug naïve/medication free patients with Type II Diabetes Mellitus

Interventions

Intervention1: EN-DM-04: 1 Tablet twice daily for 12 weeks Intervention2: EN-DM-05: 1 Tablet twice daily for 12 weeks Intervention3: EN-DM-02: 1 Tablet twice daily for 12 weeks Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients with Type 2 diabetes mellitus, with FBS 150-180 mg/dl and HbA1c of 7% to 8.5 % who are either drug ?naïve or have been medication free for at least 3 months 2) Body Mass Index between 18.5 and 30 kg/m2 Patients willing and able to follow diet and exercise regime for the study duration

Exclusion criteria

Exclusion criteria: 1) Patients requiring insulin / having diabetic complications 2) Hypertensive patients with BP ≥ 160/100 mm of Hg 3) Patients on fibrates and niacin (which are known to affect blood sugar levels) 4) Pregnant and nursing women 5) Patients unwilling to practice contraception. 6) Serious hepatic or renal impairment (Liver Dysfunction as evidenced by SGPT level of 1.5 X ULN and Renal Dysfunction as evidenced by Creatinine level of 1.5 X ULN 7) Significant cardiovascular co-morbidities, e.g. symptomatic heart failure, uncontrolled hypertension, history of ischemic heart disease (as evident from ECG), history of stroke and/or Transient Ischemic Attack. 8) Debilitating neurological or psychiatric disorders 9) Known hypersensitivity or allergy to one or more of the herbal ingredients 10) Recent (within last 3 months) participation in a clinical trial. 11) Subjects otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the study

Design outcomes

Primary

Measure	Time frame
To determine if any or all of the Investigational Products (IPs) ? EN-DM-04, EN-DM-02 and EN-DM-05 are significantly better than placebo in reducing fasting blood sugar levels (FBS) as compared to Day 25 in patients with Type II Diabetes mellitusTimepoint: Fasting Blood Sugar	—

Secondary

Measure	Time frame
To determine if any or all of the Investigational Products (IPs) ? EN-DM-04, EN-DM-02 and EN-DM-05 are significantly better than placebo in reducing HbA1c and FBS as compared to the baseline in patients with Type II Diabetes mellitus To determine if the combination product EN-DM-05 is more efficacious in lowering HbA1c and /or FBS as compared to EN-DM-02 and EN-DM-04 Timepoint: Fasting Blood Sugar (FBS) Glycosylated haemoglobin (HbA1c)	—

Measure

Time frame

To determine if any or all of the Investigational Products (IPs) ? EN-DM-04, EN-DM-02 and EN-DM-05 are significantly better than placebo in reducing HbA1c and FBS as compared to the baseline in patients with Type II Diabetes mellitus To determine if the combination product EN-DM-05 is more efficacious in lowering HbA1c and /or FBS as compared to EN-DM-02 and EN-DM-04 Timepoint: Fasting Blood Sugar (FBS) Glycosylated haemoglobin (HbA1c)

—

Countries

India

Contacts

Public ContactSeema Damakale

Vedic Lifesciences Pvt. Ltd.

medical@vediclifesciences.com022-42025703

Outcome results

None listed

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

A study to investigate the blood sugar lowering effect of EN-DM-02, EN-DM-04 and EN-DM-05 in comparison with placebo in drug na&iuml;ve/medication free patients with Type II Diabetes Mellitus under Protocol ID: VL/090707/EN/DM/EN-DM-05.