NCT05601180Completed
Evaluation of the Efficacy of Respicure® (Resveratrol / Quercetin) in the Management of Respiratory Conditions Including Asthma,COPD and Long COVID.
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 .
Source: ClinicalTrials.gov · Last updated 19 Mar 2024
Brief summary (registry, in English)
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),COPD (Stage A, B, C and D) and long COVID in Algerian Adult Patients .
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 402 (actual)
- First submitted
- 24 Oct 2022
- Start date
- 27 Oct 2022
- Primary completion date
- 15 Jan 2024
- Lead sponsor
- Beker Laboratories
- Diseases
- Asthma, COPD, Long COVID and ME/CFS
- NCT number
- NCT05601180
What you commit to
- Study type: Interventional
- Participants enrolled: 402
- From 27 Oct 2022 to the primary completion date, 15 Jan 2024
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of Respicure®.
- Concomitant use with the following products: cytochrome P450 3A4 substrate drugs (e.g. statin, antifungals and fexofenadine), antibiotics (quinolones), immunosuppressants (cyclosporine) and glycoprotein P substrate drugs, e.g. antifungal and antiarrhythmic .
- Concomitant intake of a product containing one or both of the active ingredients (resveratrol/quercetine).
- People who need to undergo surgery.
- Participation in another clinical study within the previous 30 days.
Other illness
- Hypersensitivity to any of the ingredients.
- Hypersensitivity to peanuts.
- Patient with asthma-COPD overlap syndrome or any other respiratory disease such as pneumonia, tuberculosis, pulmonary embolism, etc.
- Hormone-sensitive conditions such as breast cancer, uterine cancer, ovarian cancer, endometriosis or uterine fibroids.
Other
- Patient with severe asthma (for asthma groupe only)
- Pregnancy/ lactation.
- Patients requiring admission to intensive care and/or requiring respiratory assistance.
- Patients requiring anticoagulant treatment at curative doses.
Criteria the registry did not label
- Inclusion Criteria for Asthma patients:
- Male, female, aged ≥19.
- Being able to provide written informed consent before the study.
- Patient with partially controlled asthma: Assessment of asthma control over the month preceding the use of Respicure ® by a symptomatic assessment (Tick one or two symptoms):
- 3\. 1 Daytime symptoms more than twice a week, 3. 2 One or more nocturnal awakenings, 3. 3 Need for rescue medication more than twice a week, 3. 4 One or more activity limitations
- 4\. Patient followed for at least a year and mastering the technique of using devices i.e. aerosols, nebulizer etc…
- Inclusion Criteria for COPD patients:
- Male, female, ≥40 years old
- Being able to provide written informed consent before the study.
- Patient with COPD stage A, B, C or D in stable condition with no exacerbations in the past 4 weeks.
- Patient followed for at least a year and mastering the technique of using devices i.e. aerosols, nebulizer etc…
- Inclusion Criteria for long covid patients:
- Male, female, aged ≥19.
- Being able to provide written informed consent before the study.
- Patients followed for respiratory symptoms linked to long Covid (symptoms for more than 12 weeks).
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Beni Messous/Pneumologie A Coordinator of this site? Confirm its status | Algiers | Algeria | Unknown status |
| CHU Beni Messous/Pneumologie B Coordinator of this site? Confirm its status | Algiers | Algeria | Unknown status |
| CHU Annaba/Pneumo-phtisiologie Coordinator of this site? Confirm its status | Annaba | Algeria | Unknown status |
| EPH Batna/Pneumo-phtisiologie Coordinator of this site? Confirm its status | Batna City | Algeria | Unknown status |
| CHU Constantine/Pneumo-phtisiologie Coordinator of this site? Confirm its status | Constantine | Algeria | Unknown status |
| EPH Laghouat/Pneumo-phtisiologie Coordinator of this site? Confirm its status | Laghouat | Algeria | Unknown status |
| CHU Oran/Pneumo-phtisiologie B Coordinator of this site? Confirm its status | Oran | Algeria | Unknown status |
| CHU Sidi Bel Abbes/Pneumo-phtisiologie Coordinator of this site? Confirm its status | Sidi Bel Abbes | Algeria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.