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 .
Standard of care
+ Respicure®
COVID-19+25
+ Post-Infectious Disorders
+ Bronchial Diseases
Supportive Care Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.402 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy 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 B
Algiers, AlgeriaCHU Annaba/Pneumo-phtisiologie
Annaba, AlgeriaEPH Batna/Pneumo-phtisiologie
Batna City, Algeria