Evaluation of the Effect of a Combination of Plant Extracts (BSL_EP027) on the Incidence of Respiratory Infections

NCT04386408 | Completed Phase 1

• 1 other identifier: C027
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present study is to evaluate the effectiveness of daily consumption of a Combination of Plant Extracts (BSL\_EP027) on the incidence of respiratory infection symptoms and their duration in older healthy volunteers living in a nursing home.

Conditions

Immune Response; Respiratory Diseases

Keywords

Immunostimulation; Respiratory diseases; Plant extracts

Outcome Measures

Primary Outcomes (1)

• Respiratory infection symptoms

  Incidence of respiratory infection symptoms (fiber, cough, rinitis, headache, sore throat, bone and/or muscle pain, fatigue/exhaustion, nausea and/or vomiting, lack of appetite and /or trouble for sleeping)

  16 weeks

Secondary Outcomes (1)

• Duration of the respiratory infection symptoms

  16 weeks

Other Outcomes (3)

• Type of Medication for the respiratory infection symptoms

  16 weeks

• Dose of the Medication for the respiratory infection symptoms

  16 weeks

• Duration of the medical treatment for the respiratory infection symptoms

  16 weeks

Study Arms (2)

Combination of plant extracts (BSL_EP027)

EXPERIMENTAL

Volunteers will dissolve in water a sachet per day with the Combination of plant extracts (BSL\_EP027), and maltodextrin.

Combination Product: Combination of plant extracts (BSL_EP027)

Placebo

PLACEBO COMPARATOR

Volunteers will dissolve in water a sachet per day with maltodextrin.

Combination Product: Placebo

Interventions

Combination of plant extracts (BSL_EP027) COMBINATION_PRODUCT

Each participant will consume a sachet disolve in water once at day without any restriction in the diet nor in their habits of life.

Combination of plant extracts (BSL_EP027)

Placebo COMBINATION_PRODUCT

Each participant will consume a sachet disolve in water once at day without any restriction in the diet nor in their habits of life.

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Living in a nursing home with medical service.
• Freely accept to participate in the study and sign the informed consent document.

You may not qualify if:

• Having a disease that affects the development and results of the study.
• Suffer alterations of the state of health incompatible with the continuity in the study.
• Suffer any adverse event not tolerated by the subject.

Sponsors & Collaborators

• Biosearch S.A.: lead

Study Sites (1)

Claret Nursing home

Granada, 18011, Spain

Location

MeSH Terms

Conditions

Respiratory Tract Diseases

Study Officials

• Carlos Gracián, MD

  Doctor of the Claret Nursing Home (Granada, Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: May 13, 2020
• Study Start: November 30, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: May 13, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)