CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OFCAPSULE DIAGUARDâ?? A POLYHERBAL ANTI-DIABETIC DRUG IN PATIENTS WITH TYPE II DIABETES MELLITUS (T2DM)A DOUBLE BLIND PLACEBO CONTROLLED TRIAL - DIGD

Charak Pharma Pvt Ltd CPPL Mumbai0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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

发起方

Charak Pharma Pvt Ltd CPPL Mumbai