臨床研究等提出・公開システム

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

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

Ohba Kojiro

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki 852-8501

ohba-k@nagasaki-u.ac.jp

Mine Asami

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki 852-8501

+81-95-819-7340

a-mine@nagasaki-u.ac.jp

Not Recruiting

Sept. 24, 2020

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

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.

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.

Both

Hemodialysis

Double blind randomized

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

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.

+81-95-819-7229

July. 31, 2020

No

none