Effects of green propolis extract and royal jelly on hypertension and chronic kidney disease
Association of Green Propolis Extract and Royal Jelly to Modulate Inflammation and Oxidative Stress in Hypertensive Patients and/or With Chronic Kidney Disease
This study is testing if a combination of green propolis extract and royal jelly can help people with high blood pressure and chronic kidney disease feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 153 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Universidade Federal Fluminense Academic / other |
| Locations | 2 sites (Rio de Janeiro, Rio de Janeiro and 1 other locations) |
| Trial ID | NCT06288204 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of combining green propolis extract with royal jelly on inflammation and oxidative stress in patients suffering from chronic kidney disease (CKD) and systemic arterial hypertension (SAH). Conducted as a longitudinal, randomized, double-blind, placebo-controlled trial over two months, it aims to determine the therapeutic potential of these bee products, which are rich in bioactive compounds. Participants will receive either the combination of propolis and royal jelly, royal jelly alone, or a placebo to assess the efficacy of the treatments.
Who should consider this trial
Good fit: Ideal candidates include patients in stages 3 to 5 of chronic kidney disease who are receiving ambulatory nutrition treatment or regular hemodialysis and are on antihypertensive medications.
Not a fit: Patients with autoimmune diseases, diabetes, cancer, or those on certain medications or with specific allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel adjuvant therapy for patients with chronic kidney disease and hypertension, potentially improving their health outcomes.
How similar studies have performed: While the combination of propolis and royal jelly is a novel approach, similar studies on the individual effects of these substances have shown promising results in related health conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients in stages 3 and 5 of CKD (GFR from 15 to 59 mL/min), * patients receiving ambulatorial nutrition treatment at least 6 months * patients on regular Hemodialysis treatment for at least 6 months * patients using one to three antihypertensive drugs Exclusion Criteria: * autoimmune and infectious diseases, * diabetes * cancer * AIDS * pregnant women * patients using catabolic drugs or antibiotics; * patients with catheter access to hemodialysis; * patients using antioxidant vitamin supplements, prebiotics, probiotics, symbiotic, * Patients on regular intake of propolis who are allergic to corn starch or report being allergic to bee stings. * patients with acute myocardial infarction (AMI) and/or cerebrovascular accident (CVA)
Where this trial is running
Rio de Janeiro, Rio de Janeiro and 1 other locations
- Denise Mafra — Rio de Janeiro, Rio de Janeiro, Brazil (Recruiting)
- Denise Mafra — Rio de Janeiro, Rio de Janeiro, Brazil (Recruiting)
Study contacts
- Principal investigator: Denise Mafra, PhD — Universidade Federal Fluminense
- Study coordinator: Denise Mafra, PhD
- Email: dmafra30@gmail.com
- Phone: 5521985683003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.