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Clinical Study to Evaluate the Efficacy of Cresvin Beta Capsules in Type II Diabetes Mellitus Patients

A Prospective Randomized Comparative Clinical Study to Evaluate the Efficacy of Cresvin Beta Capsules in Type II Diabetes Mellitus Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042422
Enrollment
30
Registered
2022-05-09
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E088- Diabetes mellitus due to underlying condition with unspecified complications

Interventions

Intervention1: cresvin beta capsule 500mg: two times for a day for three months Control Intervention1: Standard Treatment: Standard Treatment

Sponsors

Apex Laboratories Pvt Ltd
Lead Sponsor
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY
Collaborator

Eligibility

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
-To evaluate the efficacy of Cresvin Beta capsules in Type II Diabetes Mellitus Patients by means of measuring patient FBS, PPBS and HBA1C values. -To assess adverse drug reactions during the study period. Timepoint: 06 months—

Secondary

MeasureTime frame
-To evaluate the adverse drug reaction during the study period..Timepoint: 06 months—

Countries

India

Contacts

Public ContactG ASVITHA

Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology,

vijaypractice@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026