Effect of a Combination of Plant Extracts (BSL_EP024) on the Immune Response

NCT ID: NCT04029558

Last Updated: 2019-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-03

Study Completion Date

2019-07-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the present trial is to study the effect of the combination of plant extracts (BSL\_EP024) in the activation of the immune response.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

More than 90% of the diseases are related, directly or indirectly, with immune alterations. Traditionally, protection against infections and improvement of the immune response has been addressed by natural means through the use of plant extracts. This activity has been attributed to phenolic compounds.

The aim of the present study is to evaluate the effect of the combination of plant extracts (BSL\_EP024) on immunological response parameters.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immune Response

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Combination of plant extracts (BSL_EP024)

The volunteers will take two capsules daily with a combination of plant extracts (BSL\_EP024)

Group Type EXPERIMENTAL

Combination of Plant Extracts (BSL_EP025)

Intervention Type DIETARY_SUPPLEMENT

Each participant will consume 2 capsules daily at lunch for 8 weeks.

Placebo

The volunteers will take two capsules daily with maltodextrin.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Each participant will consume 2 capsules daily at lunch for 8 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Combination of Plant Extracts (BSL_EP025)

Each participant will consume 2 capsules daily at lunch for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Each participant will consume 2 capsules daily at lunch for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy adult between 18 and 55 years.
* Accept freely to participate in the study and sign the informed consent document.

Exclusion Criteria

* Be under pharmacological treatments that may affect the immune response (anti-inflammatory drugs of chronic or frequent use, antiallergic treatments).
* Have allergy to some plant extracts
* Suffer from gastric problems or ulcers.
* Receive treatment with anticoagulant activity.
* Have a low expectation of adherence to the study protocol.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biosearch S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Miguel Quesada, MD, PhD

Role: STUDY_CHAIR

Medical specialist in Endocrinology, Hospital San Cecilio de Granada

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Biosearch Life

Granada, Andalusia, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.