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Efficacy of Vidangadi Lauha in Combination with Diet and Lifestyle Modification for the Management of Dyslipidemia

A Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate the Efficacy of Vidangadi Lauha with Diet and Lifestyle Modification in Medoroga (Dyslipidemia) - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084656
Enrollment
72
Registered
2025-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: E789- Disorder of lipoprotein metabolism, unspecified

Interventions

None listed

Sponsors

National Institute of Ayurveda Deemed to Be University (De-Novo) Jaipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults in the age group of 18 to 60 years of either sex. LDL-C more than or equal to 130 mg/dl and less than or equal to 190 mg/dl. Cholesterol more than or equal to 200 mg/dl and less than or equal to 300mg/dl. Triglycerides level more than or equal to 150 mg/dl and less than or equal to 300mg/dl. Those who have voluntarily signed the written informed consent.

Exclusion criteria

Exclusion criteria: Patients having history of Unstable angina, Myocardial infarction and cerebrovascular accidents. Patients having Systolic blood pressure (SBP) & Diastolic blood pressure (DBP) more than or equal to 160 &100 mm of Hg respectively. Patients with uncontrolled diabetes mellitus with FBS level more than 160 mg/dl or HbA1c higher than 8%. Patients having hypothyroidism with TSH level more than or equal to 1.5 times the upper limit of normal. Patients having statins, fibric acid derivatives, cholestyramine, nicotinic acid, proprotein convertase subtilisin/kexin type 9 inhibitors, corticosteroids, diuretics, amiodarone, cyclosporine. Patients with chronic disorders like Nephrotic syndrome, Renal failure, Auto immune disorders, Chronic Liver Disease (AST or ALT levels more than 2 times the upper limit of normal), and other serious diseases. Pregnant women and lactating mother and females of child bearing age willing to conceive during trial period.

Design outcomes

Primary

MeasureTime frame
Blood level of LDL-C. Timepoint: Baseline and end of eigth week

Secondary

MeasureTime frame
Blood levels of TC, non-HDL-C, HDL-C, TG, fasting blood glucose, high sensitivity C- reactive protein (hs-CRP), apolipoprotein (Apo) A1, Apo B, HDL, TC:HDL-C, SGOT, SGPT, S.Creatinine. Anthropometric parameters including weight,BMI, waist and hip circumference, waist to hip ratio, body fat mass, body fat percentage and QoL based on EQ-5D questionnaire, questionnaire of Medodushti Lakshana. Timepoint: Investigations will be on 0th day and end of 8th week Anthropometric parameters including weight,BMI, waist and hip circumference, waist to hip ratio, body fat mass, body fat percentage and QoL based on EQ-5D questionnaire, questionnaire of Medodushti Lakshana will be assessed on 0th day, 2nd week, 4th week, 6th week and end of 8th week

Countries

India

Contacts

Public ContactDr Sakshi Chahar

National institute of Ayurveda jaipur

dr.abhishek82@gmail.com9915613039

Outcome results

None listed

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