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Investigation on the influence of royal jelly oral intake for endothelial cell function in patients with hemodialysis

Clinical trial about the influence of royal jelly oral intake for endothelial cell function in patients with hemodialysis: Double blind, randomized trial focused on oxidative stress, macrophage activity, and cancer stem cell

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071200031
Enrollment
270
Registered
2020-09-24
Start date
2020-12-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis

Interventions

Double blind randomized

Sponsors

Ohba Kojiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Hemodialysis caused by chronic renal failure 2. Over 24 months survival after the treatment is expected. 3. Performance status is 0 - 2. 4. Age is 20 years and more. 5. Informed consent was obtained by the patient. 6. Understanding of the facts that all examinations, procedure, and treatments caused by hemodialysis were performed by Japan medical care, and that there is no compensation about the symptoms, disease and disorders in this trial.

Exclusion criteria

Exclusion criteria: 1.Have already intake of royal jelly or bee-original foods 2.Have plan to buy and take of royal jelly in future 3.Have complication of severe blood diseases that are needed the treatment. 4.Have allergy against royal jelly or bee-original foods 5.Have a history of asthma and atopic disease 6.During pregnancy or breast-feeding 7.Principle investigator or co-investigators judged as inappropriate for this study.

Design outcomes

Primary

MeasureTime frame
Levels of flow mediated dilation at 0 and 24 months after stating of the treatment

Secondary

MeasureTime frame
1. Levels of flow mediated dilation at 0, 6, 12, and 18 months after stating of the treatment 2. Levels of aort0carcification index at 0, 12, 24 months after stating of the treatment 3. Number of endothelial stem cell in the blood at 0, 3, 6, 9, 12, 15, 18, 21, 24 months after stating of the treatment 4. Serum levels of VEGF, MCSF, 8-OHdG, MDA at 0, 3, 6, 9, 12, 15, 18, 21, 24 months after stating of the treatment 5. Incidence of cardiovascular diseases, cerebrovascular diseases, and stenosis of blood access during the 24 months. 6. Adverse events of oral intake of royal jelly.

Contacts

Public ContactAsami Mine

Nagasaki University Hospital

a-mine@nagasaki-u.ac.jp+81-95-819-7340

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026