A clinical study to assess the effect of a herbal product named Glysikot granules in patients with Type 2 Diabetes Melitus

Not Applicable

Completed

Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

Registration Number: CTRI/2012/11/003123

Lead Sponsor: Clinfound Clinical Research Services P Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

1.Patients between 30-60 age, both sex.

2.Body mass index (BMI) below 40 kg/mÂ².

Group A.

1.Drug naive or previously treated Type 2 DM or patients willing to shift to sole Ayurvedic treatment.

2.Hemoglobin A1c (HbA1c) >=7.5% and <=11%

3.Fasting Plasma Glucose (FPG) >=130 mg/dL

Group B.

1.25 patients with Type 2 DM with Metformin alone having insufficient glucose control.

2.Insufficient glucose control defined as laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL

Exclusion Criteria

1.Type 1 diabetes.

2.Under Insulin treatment.

3.Complication of DM.

4.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine >1.4 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.

5.Women who are pregnant or lactating

6.Smokers/Alcoholics and/or drug abusers

7.Patient with poorly controlled Hypertension

8.Patients with evidence of malignancy

9.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 24 (End of study). HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percentTimepoint: Change from Baseline in Hemoglobin A1c (HbA1c) at Week 24 (End of study). HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent

Secondary Outcome Measures

Name	Time	Method
â?¢Change from Baseline in Fasting Plasma Glucose (FPG) to Week 24 <br/ ><br>â?¢Change from Baseline in 2-hr Post-Meal Glucose (PMG) to Week 24 <br/ ><br>â?¢Changes from Baseline in Lipid Profile to Week 24 <br/ ><br>â?¢Changes from Baseline in BMI to Week 24 <br/ ><br>â?¢Symptomatic changes assessed using Ayurvedic symptom questionnaire from Baseline to week 24 to assess changes in quality of life. <br/ ><br>Timepoint: Week 0 to Week 24