A Study to Explore the Effect of Moringa Oleifera (E-HS-01) on Flow Mediated Dilatation and Hemodynamics

NCT05002881 | Unknown

• 1 other identifier: EB/210502/MO/FMD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is designed to evaluate the modulatory effect of IP on the vascular endothelial function. To assess its vasodilatation potential, change in flow mediated dilation (FMD) and blood flow velocity (BFV) will be assessed in healthy adult male population.

Conditions

Endothelial Function

Outcome Measures

Primary Outcomes (1)

• Percent flow mediated dilatation

  To determine change in the endothelial function after single dose administration of Moringa oleifera as assessed by the change in the Percent flow mediated dilatation of brachial artery, from baseline (pre-IP administration) to 3 hours post IP administration, in comparison to the placebo.

  From baseline (pre-IP administration) to 3 hours post-IP administration

Secondary Outcomes (2)

• Blood flow velocity

  at baseline (pre-IP administration) and at 1, 2, and 3 hours post-IP administration

• Percent flow mediated dilatation

  at 1, and 2 hours post-IP administration from baseline (pre-IP administration)

Study Arms (2)

Moringa oleifera (E-HS-01)

ACTIVE COMPARATOR

One capsule to be taken stat

Other: Moringa oleifera (E-HS-01); Other: Placebo

Placebo

PLACEBO COMPARATOR

One capsule to be taken stat

Other: Moringa oleifera (E-HS-01); Other: Placebo

Interventions

Moringa oleifera (E-HS-01) OTHER

One capsule to be taken stat

Moringa oleifera (E-HS-01); Placebo

Placebo OTHER

One capsule to be taken stat

Moringa oleifera (E-HS-01); Placebo

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, physically active male volunteers aged between 20 to 35 years.
• Body mass index (BMI) ≥ 20 and ≤ 29.9 kg/m2.
• Participants with low to moderate physical activity as defined by a six-point scale score of ≥1 to ≤ 4.
• Participants with systolic blood pressure (SBP) ≤ 139 and diastolic blood pressure (DBP) ≤ 89 mm Hg.
• Ability to read and provide written, personally signed, and dated informed consent to participate in the study.
• Ready to abstain from alcohol, caffeine, and vigorous physical activity (as assessed by six point scale) for 24 hours prior to every study visit.
• Ready to abstain from beet root, moringa, and spinach for 48 hours prior to every study visit.

You may not qualify if:

• Participants with history of pulmonary disorders (asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, pneumonia, etc)
• Participants having fasting blood glucose (FBG) levels ≥ 125 mg/dL.
• Participants currently on/or having history of taking antihypertensives / diuretics.
• Smokers and tobacco users.
• Participants with heavy alcohol consumption, defined as more than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day.
• (NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol, which is equivalent to 12 ounces of beer (\~5% alcohol), 8.5 ounces of malt liquor (\~9% alcohol), 5 ounces of wine (\~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry or port), or 1.5 ounces of liquor (distilled spirits; \~40% alcohol).
• Participants currently on performance enhancing supplements.
• History/symptoms of coronary artery disease, myocardial infarction etc.
• Participants with any other condition which in the view of the investigator is likely to interfere with the study or put the participants at risk.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (1)

Vedic Lifesciences

Mumbai, Maharashtra, 400053, India

RECRUITING

Study Officials

• Dr, Anjali Jain, BHMS

  Vedic lifesciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Shalini Dr. Srivastava, MD - Medicine

CONTACT

022 42172326; shalini.s@vediclifesciences.com

Mr. Zubair Ansari, M pharm

CONTACT

7738945639; zubair@vediclifesciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, Cross-over
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Cross-over, Placebo controlled study

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 12, 2021
• Study Start: August 16, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: February 22, 2022

Record last verified: 2021-10

Locations

IN (1)