Health Condition 1: null- ADULT PATIENTS WITH NEWLY DIAGNOSED DIABETES MELLITUS
Conditions
Interventions
Intervention1: CAPSULE DIAGUARD: ONE CAPSULE TWICE DAILY FOR 12 WEEKS
Control Intervention1: PLACEBO: ONE CAPSULE TWICE A DAY FOR 12 WEEKS
Sponsors
Charak Pharma Pvt Ltd CPPL Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Minal Vaidya
YMT AYURVEDIC COLLEGE KHARGHAR, NAVIMUMBAI
Outcome results
None listed