A clinical study to understand the combined effects of Andrographis & metformin, in comparison to metformin alone treatment on glycemic control in type 2 diabetes patients
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2019/11/021977
- Lead Sponsor
- Dr Anand Kumar Maurya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
a.Patients with 18-60 years of age.
b.Newly diagnosed patients with Type-2 Diabetes Mellitus as defined by the International Diabetes Federation (IDF) guidelines 2017. (Aschner, 2017) (Refer Appendix II).
c.Written informed consent
a.Patient not willing to give informed consent.
b.Patients of Type I Diabetes Mellitus.
c.Patients with history of angina attack, heart failure, myocardial infarction.
d.Patients with history of cerebrovascular accidents.
e.Subjects on Insulin therapy
f.Subjects having liver & renal disease.
g.Subject having respiratory disease.
h.Subject having inflammatory disease.
i.Subject having genetic disorder.
j.Subject having HIV disease.
k.Subjects having any type of cancer.
l.Subjects having bacterial and viral infections.
m.Patient on other medication (hypoglycemic, steroids, hypolipidemic etc.) multidrug antihypertensive therapy.
n.Patients suffering from major medical/surgical illness.
o.Hypersensitivity to any of the used drugs.
p.Patient with autoimmune disease (like as multiple sclerosis (MS), lupus (systemic lupus erythematosus, SLE), rheumatoid arthritis (RA), or other conditions)
q.Pregnant and lactating female,Female plan for Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in glycemic control (HbA1c and fasting plasma glucose).Timepoint: 12 week
- Secondary Outcome Measures
Name Time Method Improvement in lipid profile, adiponectin, TNF-α, insulin resistance and BMI, systolic blood pressure and diastolic blood pressureTimepoint: 12 weeks