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

Comparative efficacy of Andrographis paniculata and Metformin to Metformin Monotherapy in Glycemic control in Newly Diagnosed, Treatment- naÃ¯ve Type 2 Diabetes patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/11/021977

Enrollment

120

Registered

2019-11-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

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

Interventions

Intervention1: Andrographis extract 500 mg O.D: Capsule Andrographis extract 500 mg O.D orally and Metformin 500 mg with breakfast. And Metformin 500 mg with dinner Control Intervention1: Metformin 50

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The change in glycemic control (HbA1c and fasting plasma glucose).Timepoint: 12 week	—

Secondary

Measure	Time frame
Improvement in lipid profile, adiponectin, TNF-Î±, insulin resistance and BMI, systolic blood pressure and diastolic blood pressureTimepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Anand Kumar Maurya

King George Medical University Lucknow

drsanjaykhattri@gmail.com9415008055

Outcome results

None listed

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