A study comparing an Ayurvedic medicine(Arthrakshak Dm)and atorvastatin for high cholesterol in diabetic patients

Open Labelled, Active Controlled, Randomized Comparative Clinical Trial to Evaluate the Efficacy of Arthrakshak-DM in the Management of Diabetic-induced Dyslipidemia - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101907

Enrollment

Registered

2026-01-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either gender aged between 18 years and 70 years both years inclusive. Patients having HbA1c levels between 6.5 percent and 10.0 percent indicating Type 2 Diabetes Mellitus. Patients must meet at least one of the following lipid profile criteria as per ADA ESC LAI thresholds according to 2024 guidelines. Low density lipoprotein cholesterol equal to or more than 100 milligram per decilitre. Triglyceride level equal to or more than 150 milligram per decilitre. Non high density lipoprotein cholesterol equal to or more than 130 milligram per decilitre. High density lipoprotein cholesterol equal to or less than 40 milligram per decilitre in males or equal to or less than 50 milligram per decilitre in females.

Exclusion criteria

Exclusion criteria: Patients having severe dyslipidemia with total cholesterol more than 360 milligram per decilitre. Patients having low density lipoprotein cholesterol more than 190 milligram per decilitre. Patients having triglyceride levels more than 400 milligram per decilitre. Patients having high density lipoprotein cholesterol more than 40 milligram per decilitre in males or more than 50 milligram per decilitre in females. Patients with dyslipidemia due to drug induced causes such as glucocorticoids. Patients with a recent history of myocardial infarction heart failure or stroke. Pregnant and lactating women. Patients with a history of alcoholism. Patients with known allergy or hypersensitivity to any of the study drugs. Patients with known immunosuppressive conditions such as human immunodeficiency virus infection. Patients with known active infectious diseases such as tuberculosis or hepatitis B.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of Arthrakshak-DM in reducing lipid profile abnormalities (total cholesterol, LDL, triglycerides, and HDL) in patients with Type II Diabetes-induced dyslipidemia . Timepoint: Lipid Profile (TC, LDL, HDL, TG )HBA1c,ECG,S.insulin on screening visit and 90th day	—

Secondary

Measure	Time frame
To assess the effect of Arthrakshak-DM on fasting blood glucose and HbA1c levels in patients with Type II Diabetes To assess the effect of Arthrakshak-DM on Subjective criteria To observe the impact of Arthrakshak-DM on body weight and BMI in study participants over the intervention periodTimepoint: FBS on screening visit, visit 30th day,visit 60th day ,visit 90th day	—

Countries

India

Contacts

Public ContactDr Manu R

Parul Institute of Ayurved

manu.r260022@paruluniversity.ac.in8160858967

Outcome results