Artim Phase IV Study for treatment of Type 2 Diabetes Mellitus with Mixed Dyslipidemia

An Open,Randomized,Single Centric,Active Controlled,Parallel Group,Phase IV study to evaluate the efficacy and safety of Artim capsules added to Atorvastatin and Metformin 500 mg SR versus Atorvastatin and Metformin 500 mg SR combination in type 2 diabetes patients with mixed dyslipidemia.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/02/005565

Enrollment

Registered

2015-02-23

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: null- Type 2 Diabetes patients with mixed dyslipidemia

Interventions

Intervention1: Artim capsules added to Atorvastatin and Metformin 500 mg SR: Artim is combination of Terminalia arjuna, Apium graveolens, Boerhavia diffusa, Allium sativum, Morringa oleifera, Vinis vi

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female patients of age between 18-65 years. 2.Type II diabetes patients with mixed dyslipidemia treated with Metformin 500 mg SR and atorvastatin 10 mg , and are on diet therapy( as described by nutritionist) 3.Patients with LDL >130 mg/dl or triglycerides above 200mg/dl or total cholesterol above 200mg/dl 4.Patients with HbA1c (%) levels in the range of 7.0-9.0 5.Female subjects of child bearing potential should have negative Urine Pregnancy Test (UPT) at the time of screening. 6.Patients or patientâ??s legally acceptable representative willing to sign the Informed Consent Form. 7.Patients willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, and compliance with protocol requirements.

Exclusion criteria

Exclusion criteria: 1.Hypersensitivity to any of the study medications 2.Clinically relevant or unstable cardiovascular diseases 3.Severe hepatic or renal disease 4.Type 1 or poorly controlled type 2 diabetes mellitus(fasting > 200mg/dl) 5.History of drug or alcohol abuse 6.Pregnant and nursing mothers 7.Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety 8.Participation in a clinical trial of an experimental drug within the previous month.

Design outcomes

Primary

Measure	Time frame
â?¢Change in Blood glucose (fasting and post prandial) as compared to baseline â?¢Change in HbA1c (%) levels as compared to baseline â?¢Change Lipid profile testing as compared to baselineTimepoint: 30,60 and 90 days	—

Secondary

Measure	Time frame
Tolerability and changes in serum biochemistry post treatment as compared to baselineTimepoint: 1 and 90 days	—

Countries

India

Contacts

Public ContactDr Manjusha Patankar

Clinical Medicine Infomatics (India) Pvt. Ltd.

manjusha.patankar22@gmail.com9022622600

Outcome results

None listed

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