UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053366 |
|---|---|
| Receipt number | R000060902 |
| Scientific Title | Efficacy Evaluation of the Alleviating Effect of Coriander Powder Intake on Nasal Discomfort during Cedar Pollen Dispersion - A Randomized, Double-blind, Placebo-Controlled Parallel Group Comparative Trial- |
| Date of disclosure of the study information | 2024/02/09 |
| Last modified on | 2024/05/21 14:16:58 |
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Basic information
Public title
Efficacy Evaluation of the Alleviating Effect of Coriander Powder Intake on Nasal Discomfort during Cedar Pollen Dispersion - A Randomized, Double-blind, Placebo-Controlled Parallel Group Comparative Trial-
Acronym
Efficacy Evaluation of the Alleviating Effect of Coriander Powder Intake on Nasal Discomfort during Cedar Pollen Dispersion
Scientific Title
Efficacy Evaluation of the Alleviating Effect of Coriander Powder Intake on Nasal Discomfort during Cedar Pollen Dispersion - A Randomized, Double-blind, Placebo-Controlled Parallel Group Comparative Trial-
Scientific Title:Acronym
Efficacy Evaluation of the Alleviating Effect of Coriander Powder Intake on Nasal Discomfort during Cedar Pollen Dispersion
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate the effectiveness and safety against nasal and eye discomfort (sneezing, runny nose, nasal congestion, eye itchiness, etc.) caused by cedar pollen, by having male and female healthy subjects with nasal symptoms such as sneezing, runny nose, and nasal congestion caused by cedar pollen, ingest the research food for 8 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JRQLQ Nasal Symptom Score
Key secondary outcomes
- JRQLQ Eye Symptom Score and QOL (Quality of Life) Score
- Nasal Cavity Evaluation (Expansion of inferior nasal concha mucosa, Color tone of inferior nasal concha mucosa, Watery secretion amount and nasal fluid properties)
- Cedar-specific IgE, Non-specific IgE
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume 12 capsules/day of the test food every day for 8 weeks, accompanied by about 100 mL of water or lukewarm water, after breakfast or in the morning.
Interventions/Control_2
Consume 12 capsules/day of the placebo food every day for 8 weeks, accompanied by about 100 mL of water or lukewarm water, after breakfast or in the morning.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age: 20 or above and under 65 (at the time of consent).
2. Gender: Japanese nationality males and females.
3. Those who have nasal symptoms such as sneezing, runny nose, and nasal congestion caused by cedar pollen, but are judged by the research physician to have no problem participating in this trial.
4. Those who do not "take" or "sometimes take but do not regularly take" allergy medications before and during the research: Those who sometimes take are to be less than half of all subjects.
5. Those with a BMI less than 30 kg/m^2.
6. Those who can cooperate in taking the research food for 8 weeks.
7. Those who can enter electronic diaries via smartphones or PCs.
8. Those who have received a sufficient explanation about the purpose and content of this trial, have the ability to consent, understand well, voluntarily wish to participate, and can consent in writing to participate in this research.
9. Those who are judged by the research physician to not be patients and are deemed suitable to participate in this trial.
Key exclusion criteria
1. Those currently receiving medical treatment or treatment with medicines or Kampo for any disease (intermittent use is acceptable).
2. Those with acute rhinitis, sinusitis, nasal polyps, deviated nasal septum, etc..
3. Those who have undergone nasal cavity surgery.
4. Those with bronchial asthma.
5. Those who have or had serious liver, kidney, heart, respiratory, endocrine, metabolic diseases, etc. (appendicitis is acceptable).
6. Those undergoing specific desensitization therapy.
7. Those who regularly consume lactic acid bacteria products, lactic acid bacteria supplements, and yogurt (3 or more times a week) (those who can suspend consumption during the study period are acceptable).
8. Those who regularly consume foods with anti-allergy effects such as sweet tea and benifuuki tea (3 or more times a week) (those who can suspend consumption during the study period are acceptable).
9. Those who may have allergic symptoms to the research food.
10. Those who consume healthy foods (foods or supplements aimed at maintaining or recovering health) (those who can suspend consumption during the study period are acceptable).
11. Those with a current or past history of drug allergy or food allergy.
12. Those who have participated in other clinical trials within one month before consent acquisition or are currently participating.
13. Those who are currently pregnant or breastfeeding, and those who wish to become pregnant.
14. Those with excessive drinking habits exceeding about 40 g of pure alcohol per day.
15. Those with smoking habits (less than one year after quitting).
16. Those with shift work including night shifts.
17. Those who have experienced discomfort or deterioration of physical condition due to blood collection in the past.
18. Those who may change their lifestyle during the study period, such as long-term travel.
19. Others whom the research physician judges to be inappropriate as subjects of this trial.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Onda |
Organization
S&B FOODS INC.
Division name
Functional food Research and Development Unit, Central Research Institute
Zip code
136-0082
Address
#605 Mitsui Link-Lab, Shinkiba 1, 2-3-8 Shinkiba, Koto-ku, Tokyo 136-0082, Japan
TEL
03-3558-5531
hiroyuki_onda@sbfoods.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co, Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
Daiwa Ginza Bld. 3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
0367045968
Homepage URL
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
S&B FOODS INC.
Institute
Department
Personal name
Funding Source
Organization
S&B FOODS INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
0367045968
jimukyoku@imeqrd.co.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
| 2024 | Year | 02 | Month | 09 | 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
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
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060902
