Clinical study to evaluate the efficacy and safety of capsule Diaguard - A polyherbal anti-diabetic drug in patients with type - II diabetes mellitus

Phase 2

Conditions: Health Condition 1: null- ADULT PATIENTS WITH NEWLY DIAGNOSED DIABETES MELLITUS

Registration Number: CTRI/2015/03/005644

Lead Sponsor: Charak Pharma Pvt Ltd CPPL Mumbai

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

The participant may enter the trial if ALL of the following apply:

Participant is willing and able to give informed consent for participation in the trial

Male or female, aged 21 to 65 years

Diagnosed with Type 2 DM, whose fasting plasma glucose (FPG) is greater than 150 mg% and/or Post lunch (2 hrs) plasma glucose (PPPG) is greater than 200 mg%

HbA1c in range of 7% to 10%

Participant has clinically acceptable laboratory results

In the investigatorâ??s opinion is able and willing to comply with all trial requirements

Exclusion Criteria

The participant may not enter the trial if ANY of the following apply:

Female participant who is pregnant, lactating or planning pregnancy Type I DM patients

Type II DM patients who require insulin or OHAs for management of diabetic complications

FPG equal or less than 150 mg % and PPPG equal or less than 200 mg %

HbA1c greater than 10

Significant cardiac, renal or hepatic impairment

Scheduled elective surgery or other procedures requiring general anaesthesia during the trial

Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participantâ??s ability to participate in the trial

Participants who have participated in another research trial involving an investigational product in the past 12 weeks

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To assess anti-diabetic activity of Capsule Diaguard compared with Placebo Capsules in patients with Type II DM patientsTimepoint: Number of patients showing response i.e. reduction in Fasting Plasma Glucose (FPG) and Post Prandial Plasma Glucose (PPPG) after 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
1.To assess hypolipidemic activity of Capsule Diaguard compared with placebo capsules in patients with Type II DM patientsTimepoint: 1.Number of patients showing reduction in plasma lipid levels (viz. LDL Cholesterol, VLDL Cholesterol and Triglycerides) and increase in HDL Cholesterol after 12 weeks of treatment