Clinical Study to Evaluate the Efficacy of Cresvin Beta Capsules in Type II Diabetes Mellitus Patients
- Conditions
- Health Condition 1: E088- Diabetes mellitus due to underlying condition with unspecified complications
- Registration Number
- CTRI/2022/05/042422
- Lead Sponsor
- Apex Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Male or female patients within the age range of 18 to 60 years (both years inclusive) diagnosed with T2DM for at least 3 months.
-Willingness to provide written informed consent to participate in the study.
-Patients understanding the nature and purpose of the study and who are willing to comply with study procedures.
-Fasting plasma glucose greater than or equal to 126 mg/dL
-Random plasma glucose greater than 200 mg/dL in a person with symptoms of diabetes.
-Duration of diabetes â?? Newly diagnosed diabetics or diagnosed within past 5 years
-HbA1C between 7-9.5%
-Type 1 diabetes mellitus
-Patients with severe hyperglycemia (FBS greater than 234 mg per dl or PPBS greater than 360 mg per dl
-HbA1C is more than 9.5 per cent.
-ASAT and ALT levels greater than 2.5 times the upper normal limits
ï?§Severe renal, hepatic, cardiac, gastrointestinal, neurological, hematological or respiratory
ï?§disorders, in view of the investigator.
ï?§Patients with psychiatric disorder.
ï?§History of smoking (more than 10 cigarettes/day) or alcohol intake > 20gm/day.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -To evaluate the efficacy of Cresvin Beta capsules in Type II Diabetes Mellitus Patients by means of measuring patient FBS, PPBS and HBA1C values. <br/ ><br>-To assess adverse drug reactions during the study period. <br/ ><br>Timepoint: 06 months
- Secondary Outcome Measures
Name Time Method -To evaluate the adverse drug reaction during the study period..Timepoint: 06 months