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.

Phase 1

• Conditions: Health Condition 1: null- Drug naïve/medication free patients with Type II Diabetes Mellitus

• Registration Number: CTRI/2011/09/001996
• Lead Sponsor: Exotic Naturals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 48

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br>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<br>Timepoint: Fasting Blood Sugar (FBS)<br>Glycosylated haemoglobin (HbA1c)