Scientific Evaluation of an Ayurveda medicine in tablet form in Diabetic patients

Not Applicable

Completed

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

Registration Number: CTRI/2013/08/003868

Lead Sponsor: Clinfound Clinical Research Services Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients between 30-65 age, both sex.

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

Group A

1.25 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 Modern Pharmaceutical Medication 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.Current need for 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 > 1.6mg/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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12 (End of study).Timepoint: Visit 1(Day 1) and Visit 12(Day 90)

Secondary Outcome Measures

Name	Time	Method
Body Mass Index and Blood PressureTimepoint: Visit 1, Week 2,Week 4, Week 6,Week 8, Week 10, Week 12;Change from Baseline in 2-hr Post-Meal Glucose (PMG) to Week 12Timepoint: Visit 1,Week 2,Week 4,Week 6, Week 8,Week 10, Week 12;Change from Baseline in Fasting Plasma Glucose (FPG) to Week 12 <br/ ><br>Timepoint: Vist 1, Week2,Week4,Week 6, Week 8,Week 10,Week 12;Symptomatic changes assessed using Ayurvedic symptom questionnaire from Baseline to week 12 to assess changes in quality of life. <br/ ><br>Timepoint: Visit 1,Week 2,Week 4,Week 6,Week 8, Week 10, Week 12