clinical study to assess the effectiveness and safety of ayurvedic herbomineral drug "shivagutika" in management of high cholesterol.

Single blind randomized controlled clinical study to evaluate the efficacy and safety of shivagutika in dyslipidemia

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/05/008545

Enrollment

Registered

2017-05-12

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: E038- Other specified hypothyroidism

Interventions

Intervention1: Tablet shivagutika: Group B (Test)Tab Shivagutika, 2gram per day in two equally divided dose given orally morning and night- after meals for 45 days duration. Control Intervention1: Tab

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients fulfilling the diagnostic criteria. 2.Lipid profile, showing any one or more of the following criteria. Serum cholesterol >200 mg/dl Serum Triglycerides >150 mg/dl Serum LDL >130 mg/dl Serum VLDL >40 mg/dl Serum HDL Ratio of HDL to Cholesterol >4.5 Apolipoprotien B >125mg/dl 3.Both fresh and treated cases will be included (Flush out period of 7 days is maintained for treated cases)

Exclusion criteria

Exclusion criteria: 1.Patients having history of serious cardiac disorders like myocardial infarction, cardiac failure, etc. 2.Patients having any major illness, insulin dependent diabetes mellitus, Type II diabetes mellitus that is poorly controlled 3.Patients having a history of untreated thyroid disorder 4.Hyperlipidemia due to drugs (e.g., glucocorticoids) 5.Pregnant females and lactating mothers 6.Renal insufficiency

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of shivagutika in dyslipidemia (lipid profile and on Apo lipoprotein B). To evaluate the effect of Navaka guggulu in dyslipidemia (lipid profile and on Apo lipoprotein B). To evaluate the safety of shiva gutika and Navaka guggulu. To compare the efficacy of shiva gutika with control drug Navaka guggulu. Timepoint: Lipid profile,Apolipoprotien B,Liver function tests will be performed before intervention and after 45 days of intervention.	—

Measure

Time frame

To evaluate the effect of shivagutika in dyslipidemia (lipid profile and on Apo lipoprotein B). To evaluate the effect of Navaka guggulu in dyslipidemia (lipid profile and on Apo lipoprotein B). To evaluate the safety of shiva gutika and Navaka guggulu. To compare the efficacy of shiva gutika with control drug Navaka guggulu. Timepoint: Lipid profile,Apolipoprotien B,Liver function tests will be performed before intervention and after 45 days of intervention.

—

Secondary

Measure	Time frame
Safe and cost effective natural drug for managing dyslipidemia, prevention of coronary artery diseases.Timepoint: 0 day and 45th day	—

Countries

India

Contacts

Public ContactDr Gajanana Hegde

Govt Ayurveda Medical College and Hospital

dr.hegdegajanana@gmail.com9448738936

Outcome results

None listed

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