Completed

Interventional, Prospective, National, Multicentre, Randomised, Open-label, Controlled Clinical Study Comparing Two Parallel Groups, One Control Arm (Standard Treatment) Versus Intervention Arm (Standard Treatment + Study Product) Evaluating the Efficacy of Respicure® 0.38% /0.38% (Resveratrol / Quercetin) Phytotherapy Product From BEKER® Laboratories as an add-on Treatment in the Management of Respiratory Conditions Including Asthma (Partially Controlled),Chronic Obstructive Pulmonary Disease "COPD" (Stage A, B, C and D) and Long Coronavirus Disease "COVID" in Algerian Adult Patients .

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What is being tested

Standard of care

+ Respicure®

Other
Who is being recruted

COVID-19+25

+ Post-Infectious Disorders

+ Bronchial Diseases

Over 19 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: October 2022
See protocol details

Summary

Principal SponsorBeker Laboratories
Last updated: March 19, 2024
Sourced from a government-validated database.Claim as a partner

Study start date: October 27, 2022

Actual date on which the first participant was enrolled.

This is an interventional, prospective, national, multicenteric, randomized, open-label, controlled clinical study comparing two arms: Control arm taking the standard of care Versus Intervention arm (standard of care + Respicure®). A total of 480 patients (160 in each group of pathology i.e Asthme, COPD and long COVID, distributed through 8 centers resulting in 20 patients/center for each group of pathology). The administration of the study product is by randomaisation.The data will be collected during 5 visits for the two arms as following: Visit V1 on D0: inclusion, signature of informed consent and implementation of the RESPIRE DZ protocol with delivery to patients of a one-month supply of Respicure® for the intervention arm, Intermediary visit on D15: face-to-face and/or by telephone to assess safety after the use of Respicure® for the intervention arm. Visit V2 on D30: follow-up visit with delivery to patients of a one-month supply of Respicure® for the intervention arm, Visit V3 on D60: follow-up visit with delivery to patients of a one-month supply of Respicure® for the intervention arm, Visit V4 at D90:follow-up visit at the end of the use of the study product, Visit V5 at D180: follow-up and end-of-study visit.

Principal SponsorBeker Laboratories
Last updated: March 19, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

402 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

COVID-19Post-Infectious DisordersBronchial DiseasesChronic DiseaseCoronaviridae InfectionsHypersensitivityHypersensitivity, ImmediateImmune System DiseasesInfectionsLung DiseasesLung Diseases, ObstructivePathologic ProcessesPneumoniaPneumonia, ViralRespiration DisordersRespiratory HypersensitivityRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsPathological Conditions, Signs and SymptomsVirus DiseasesCoronavirus InfectionsDisease AttributesNidovirales InfectionsPost-Acute COVID-19 SyndromeAsthmaPulmonary Disease, Chronic ObstructiveRespiratory Aspiration

Criteria

13 exclusion criteria prevent from participating
Participation in another clinical study within the previous 30 days.

Pregnancy/ lactation.

Hypersensitivity to peanuts.

Patients requiring admission to intensive care and/or requiring respiratory assistance.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
standard treatment that is prescribed by the treating physician.

Group II

Experimental
standard treatment that is prescribed by the treating physician in addition to Respicure®

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

CHU Beni Messous/Pneumologie A

Algiers, AlgeriaOpen CHU Beni Messous/Pneumologie A in Google Maps

CHU Beni Messous/Pneumologie B

Algiers, Algeria

CHU Annaba/Pneumo-phtisiologie

Annaba, Algeria

EPH Batna/Pneumo-phtisiologie

Batna City, Algeria
Completed8 Study Centers