CTRI/2022/05/042422
Not yet recruiting
未知
A Prospective Randomized Comparative Clinical Study to Evaluate the Efficacy of Cresvin Beta Capsules in Type II Diabetes Mellitus Patients
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: E088- Diabetes mellitus due to underlying condition with unspecified complications
- Sponsor
- Apex Laboratories Pvt Ltd
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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%
Exclusion Criteria
- •\-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.
Outcomes
Primary Outcomes
Not specified
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