A clinical trial to determine the effectiveness of Veppampoo Maathirai in the management of deepana silethma noi (dyslipidemia)

A prospective open labelled,single arm,non-randomized,single centric, phase II,clinical trial to determine the effectiveness of veppampoo maathirai in the management of deepana silethma noi (dyslipidemia)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068380

Enrollment

Registered

2024-06-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: E785- Hyperlipidemia, unspecified

Interventions

Intervention1: Veppampoo Maathirai: 1 to 2 Pills (Twice a day orally) Before food for 3 months Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosis of primary dyslipidemia 2.TC above 200 mg /dl,LDL above 130mg/dl,VLDL above 30mg/dl,TG above 200mg/dl 3.Having not taking any Lipid Lowering Drugs within the past 1 month 4.Able to adhere to long term treatment 5.Willing and able to follow the scheduled visit plan, diet and exercise instructions, laboratory tests,and other procedures 6.Having voluntarily given their informed consent

Exclusion criteria

Exclusion criteria: 1.History of CAD/ CVA within the past 4 weeks 2.Combined with nephrotic syndrome, or renal insufficiency 3.Combined with poorly controlled hypothyroidism or other endocrine disease 4.Combined with severe or active liver diseases 5.Combined with severe or any other life threatening disease 6.Allergy to component of the product or allergic constitution 7.Combined with mental disorders 8.Participated in clinical trials of other drugs in the past 4 weeks

Design outcomes

Primary

Measure	Time frame
To determine the clinical effectiveness of Veppampoo Maathirai (internal) in the management of Deepana silethma noi(Dyslipidemia) and to evaluate the change in LDL from baseline to week 12Timepoint: 3 months	—

Secondary

Measure	Time frame
1.To collect various aspects of Deepana silethma noi in Siddha literatures. 2.To evaluate physico chemical,phyto chemical and bio chemical characters of Veppampoo maathirai. 3. To evaluate safety profile for assessing acute and sub-acute toxicity of trial drug Veppampoo maathirai. 4.To evaluate pharmacological analysis of Veppampoo maathirai . 5.Study about the prevalence of Deepana silethma noi in relation between diet and life style. 6.To evaluate siddha parameters (including Envagai thervu) changes and dhegi in Deepana silethma noi during the study period. 7. To evaluate modern parametric changes in Deepana silethma noi. 8.To document the Bio statistical analysis. 9. To assess the Quality of life of Deepana silethma noi patients.Timepoint: 6 months	—

Measure

Time frame

1.To collect various aspects of Deepana silethma noi in Siddha literatures. 2.To evaluate physico chemical,phyto chemical and bio chemical characters of Veppampoo maathirai. 3. To evaluate safety profile for assessing acute and sub-acute toxicity of trial drug Veppampoo maathirai. 4.To evaluate pharmacological analysis of Veppampoo maathirai . 5.Study about the prevalence of Deepana silethma noi in relation between diet and life style. 6.To evaluate siddha parameters (including Envagai thervu) changes and dhegi in Deepana silethma noi during the study period. 7. To evaluate modern parametric changes in Deepana silethma noi. 8.To document the Bio statistical analysis. 9. To assess the Quality of life of Deepana silethma noi patients.Timepoint: 6 months

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Countries

India

Contacts

Public ContactProf Dr T Komalavalli Alias Mehala

Government Siddha Medical College and Hospital Palayamkottai

siddhadrgs21@gmail.com9345600723

Outcome results

None listed

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