A clinical trial to evaluate Anti diabetic potential of ARLPK01

Phase 2

Conditions: Health Condition 1: null- Type II Diabetes mellitus

Registration Number: CTRI/2014/10/005121

Lead Sponsor: ARVIND REMIDIES LTD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Both gender

Age 30-55 years.

Patients whose duration of Type 2 Diabetes mellitus for 0-8years.

Patients with stable dose of metformin for atleast 3 months.

Patients with fasting glucose level <130mg/dl and Postprandial glucose level <250mg/dl

Patients with HbA1c between 7.0-8.5 %.

Patients ready to abide by trial procedures and to give informed consent.

Exclusion Criteria

Type 1 Diabetes mellitus and Gestational Diabetes Mellitus.

Patients with HbA1c more than 8.5 %.

Complications of diabetes such as Diabetic retinopathy, Diabetic Neuropathy and Diabetic Nephropathy.

Patients with Cardiovascular Disorders, kidney and liver complications

Ischemic heart disease with any cardiac event in last 6 months.

Patients who are likely to undergo surgery during the study period.

Patients who have participated in any investigational study in the last 8 weeks.

Patients having known hypersensitivity to the study drugs and Patients with any severe infection .

Patients with a history of intake of any Ayurvedic /herbal/homeopathic or any alternative therapies in the last one month.

Pregnant or lactating females.

Any clinical relevant abnormal physical or laboratory findings at the screening examination as judged by the investigator which would interfere with the objectives of the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the beta cell regeneration. <br/ ><br>Change in the glycosylated haemoglobin (HbA1c) levels from the base line to end of the treatment. <br/ ><br>Timepoint: 12months

Secondary Outcome Measures

Name	Time	Method
Change in the fasting and post prandial glucose levels from the base line to the end of the treatment. <br/ ><br>Number of patients who have achieved the glycosylated haemoglobin (HbA1c) less than 7. <br/ ><br>To compare the mean change of complete lipid profile (triglycerides, HDL, LDL, total cholesterol) from base line to end of the treatment between the treatment groups. <br/ ><br>Determination of Insulin sensitization activity . <br/ ><br>Comparison of Adverse event profile between the treatment groups. <br/ ><br>Timepoint: 12 months