UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047517 |
|---|---|
| Receipt number | R000053723 |
| Scientific Title | Study on the effect of honey products on Parkinson's disease |
| Date of disclosure of the study information | 2022/04/18 |
| Last modified on | 2024/04/18 09:08:47 |
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Basic information
Public title
Study on the effect of honey products on Parkinson's disease
Acronym
Study on the effect of honey products on Parkinson's disease
Scientific Title
Study on the effect of honey products on Parkinson's disease
Scientific Title:Acronym
Study on the effect of honey products on Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been reported that small intestinal bacterial overgrowth (SIBO) is frequently associated with Parkinson's disease. SIBO also affects the absorption of antiparkinsonian drugs in the small intestine, and it has been reported that fluctuation of motor symptoms(wearing off) is exacerbated. Treatment for SIBO is necessary for antiparkinsonian drugs to be fully effective, but long-term use of antibiotics is difficult due to the problem of resistant bacteria. Therefore, we focused on the honey products that can be ingested on a daily basis and are said to have a strong antibacterial effect, and thought that ingestion of these could improve the fluctuation of motor symptoms in Parkinson's disease. This study examines the effects of honey products on patients with Parkinson's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average daily off-time changes from baseline (7-day pre-evaluation mean during treatment-baseline 7-day pre-evaluation mean)
Key secondary outcomes
Average daily off-time (average value for 7 days before each evaluation), UPDRS part II total score, UPDRS part III total score, PDQ-39summary Index and domain score
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with Parkinson's disease by the British Brain Bank Clinical Criteria
2) Patients with H & Y classification 2-4 degrees
3) Patients aged between 20 and 85 at the time of consent
4) Patients who have been treated with levodopa for 6 months or more by the time consent is obtained and who have a wearing-off phenomenon
5) Patients receiving levodopa therapy at a fixed dosage and administration (3 times a day or more) from the start of observation
6) Patients who have been receiving a certain dosage and administration from the start of observation when using entacapone and opicapone together
7) Patients receiving a certain dosage and administration from 14 days before the start of observation when using a combination of dopamine agonist, amantadine, anticholinergic drug, droxidopa, istradefylline or zonisamide
8) Patients who have given written consent to participate in this study
Key exclusion criteria
1) Patients with serious physical symptoms other than Parkinson's disease (cardiac / liver / renal dysfunction, hematopoietic disorders, etc.)
2) Viral hepatitis: HBsAg positive or HCV antibody positive
3) Women who are pregnant or may become pregnant
4) Patients with drug addiction / alcohol dependence
5) Patients with serious psychiatric symptoms (confusion, hallucinations, delusions, abnormal behavior, etc.) within 3 months before obtaining the consent form
6) In addition, when the principal investigator or the research coordinator judges that participation in this research is not appropriate.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Takuyuki |
| Middle name | |
| Last name | Endo |
Organization
Osaka Toneyama Medical Center
Division name
Neurology
Zip code
565-0873
Address
5-1-1, Toneyama, Toyonaka, Osaka
TEL
+81-6-6853-2001
endo.takuyuki.gr@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | TAKUYUKI |
| Middle name | |
| Last name | ENDO |
Organization
Osaka Toneyama Medical Center
Division name
Neurology
Zip code
565-0873
Address
5-1-1, Toneyama, Toyonaka, Osaka
TEL
09052438859
Homepage URL
endo.takuyuki.gr@mail.hosp.go.jp
Sponsor or person
Institute
Osaka Toneyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Toneyama Medical Center Clinical Research Review Committee
Address
5-1-1, Toneyama, Toyonaka, Osaka
Tel
0668532001
410-chiken@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
7
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The planned number of cases is 12.
Divide the intake patterns A, B, and C, and carry out a crossover test in which 2, 4, and 6 are replaced according to the following schedule.
1.Observation period 14 days (assigned at the time of evaluation)
2. Placebo x 14 days Oral intake
3. Washout 14 days
4. Manuka honey 600 mg / day x 14 days Oral intake
5. Washout 14 days
6. Propolis 600 mg / day x 14 days Oral intake
Self-administered symptom diary, PDQ-39 (self-administered ADL score) and Neurological symptom evaluation (UPDRS = Unified Parkinson Disease Rating Scale part I-IV) are described for the study.
Average daily off-time change from baseline (7-day mean before baseline evaluation-mean 7 days before baseline evaluation) is the primary end-point.
Average off time per day (mean value for 7 days before each evaluation), UPDRS part II total score, UPDRS part III total score, PDQ-39 summary Index and domain score are the secondary end-point.
Management information
Registered date
| 2022 | Year | 04 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053723
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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