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Efficacy of a Multisource Edible Oil on the improvement of heart health.

An open label, multi centric, controlled observational clinical study to determine the efficacy of Multi Source Edible Oil (MSEO1) on outcomes in patients with cardiovascular disease.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/10/046352
Enrollment
60
Registered
2022-10-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: Emami Multisource Edible Oil (MSEO1) as cooking oil: dose- 30 ml per day frequency route of administration - edible cooking oil, to be taken internally duration of intervention - 28 day

Sponsors

Med Pharma CRO
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female subjects in the age group of 18 years and above. 2. Participants suffering under any one or more of the signs and symptoms like hypertension, dyslipidaemia. 3. Participants willing to give written informed consent. 4. Participants are fit and no need any hospital administration. 5. Willing to cook with the supplied oil and ability to adhere to dosing and visit schedules and meet study requirements. 6. Agree to following instruction of doââ?¬•s and donââ?¬•ts in regular daily lifestyle. 7. Study participants willing to perform all study related procedures allowing the physical and other invasive or non-invasive tests and willing to document symptoms and medication.

Exclusion criteria

Exclusion criteria: 1. Study participants unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study. 2. Inability to carry out testing for the study. 3. Chronic & acute disorders requiring hospital admission. 4. Known HIV-positive, Hepatitis B or C status.

Design outcomes

Primary

MeasureTime frame
1.Improvement of Cholesterol 2.Improvement of Blood Pressure 3.Maintaining Cardiovascular Health 4.Improvement of GI issues BMI, BP, CBC, Lipid profile, hsCRP, CPK, Vitamin KTimepoint: BMI, BP, CBC, Lipid profile, hsCRP, CPK, Vitamin K Baseline compared after 28 days then crosover (washout phase 7 days) and again compared after 28 days

Secondary

MeasureTime frame
No serious adverse eventsTimepoint: 28 days each group

Countries

India

Contacts

Public ContactDR PARIKSHIT DEBNATH

MED PHARMA CRO

docdebnath84@gmail.com9836675720

Outcome results

None listed

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