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

Not Applicable

Not yet recruiting

• Conditions: Hyperlipidemia, unspecified,

• Registration Number: CTRI/2022/10/046352
• Lead Sponsor: Med Pharma CRO

Brief Summary

Open label multicentric post-marketing  study will be undertaken at Kolkata. Study design will be crossover and each group will consume the study oil (MSEO1) and control oil (MSEO2) for 28 days each with a washout phase of 7 days in between. A total of 60 study participants having dyslipidemia and/or hypertension will be equally distributed in 2 groups (study and control). Primary outcome are maintaing cardiovascular health, improvement in cholesterol and blood pressure levels. Secondary outcomes wlll be monioring adverse events. After screening participants giving written informed consent will be enrolled in respective groups. Then they will undergo physical assessment, assessment with study questionnaire and biochemical tests. Study oils will be provided to participants free of cost.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-13
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

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 do’s and don’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

• 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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Improvement of Cholesterol	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
2.Improvement of Blood Pressure	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
3.Maintaining Cardiovascular Health	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
4.Improvement of GI issues	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
BMI, BP, CBC, Lipid profile, hsCRP, CPK, Vitamin K	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 Outcome Measures

Name	Time	Method
No serious adverse events	28 days each group

Trial Locations

Locations (2)

Aktriana Ayurveda and Wellness; 🇮🇳 Kolkata, WEST BENGAL, India

The Ayurveda Clinic and Research Centre; 🇮🇳 Kolkata, WEST BENGAL, India

Aktriana Ayurveda and Wellness

🇮🇳Kolkata, WEST BENGAL, India

Dr Parikshit Debnath

Principal investigator

9836675720

docdebnath84@gmail.com