UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012996 |
|---|---|
| Receipt number | R000014474 |
| Scientific Title | Akamuku for seasonal allergic rhinitis; singlecenter double blind randomized control trial |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2016/10/15 01:23:43 |
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Basic information
Public title
Akamuku for seasonal allergic rhinitis;
singlecenter double blind randomized control trial
Acronym
Akamuku for seasonal allergic rhinitis
Scientific Title
Akamuku for seasonal allergic rhinitis;
singlecenter double blind randomized control trial
Scientific Title:Acronym
Akamuku for seasonal allergic rhinitis
Region
| Japan |
Condition
Condition
seasonal allergic rhinitis
Classification by specialty
| Clinical immunology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Seasonal allergic rhinitis (SAR) is rapidly increasing and approximately 29.8% of Japanese people suffer from this disease. SAR causes discomfort and decreasing the quality of life (QOL). Despite advances in treatment and consensus guidelines for management of SAR condition, many patients seek complementary and alternative therapies for their symptom.
Chlorophyll c2 extracted from Sargassum horneri (S. horneri), which is a genus of brown seaweed, depressed the degranulation of basophilic leukemia cell and improved allergic symptom in animal study. Chlorophyll c2 is under product development and is hoped for new alternative therapy of allergic rhinitis.
We hypothesized that chlorophyll c2 extracted from S, horneri would lead to improved seasonal allergic rhinitis (SAR) specific quality of life and reduce the overall need for antihistamines.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary trial outcomes were change in symptoms and change in need for medication between baseline and 4 week after treatment.
We assessed symptoms by using the disease-specific Japan Rhinitis Quality of Life Questionnaire (JRQLQ). The JRQLQ has 24 questions in 8 domains of nose and eye symptoms, usual daily activities, outdoor activities, social functioning, sleep problems, general physical problems and emotional function, and the overall QOL. Each questions evaluate symptom on a five-point scale (0 for no symptoms, 1 for mild, 2 for moderately severe, 3 for severe and 4 for very severe symptoms).
Medication need was measured using an rescue medication score (RMS), comprising the weekly sum of daily assessments (fexofenadine 60 mg/d, or equivalent [1 point]; fexofenadine 120 mg/d, or equivalent [2 points]; and any form of nasal steroids for SAR [2 points]) (daily range, 0 to 4; weekly range, 0 to 28).
Key secondary outcomes
Secondary trial outcomes were change in symptoms and change in need for medication between baseline and 8, 12 week after treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intervention group have extracted chlorophyll c2 0.7g/day for 12 weeks.
Interventions/Control_2
Control group have placebo for 12 week.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients are eligible to participate in the study if they had a history of SAR of at least 2years.
Key exclusion criteria
Patients are excluded if they had received intranasal or oral prophylactic therapy that season; had known serious renal, cardiac, or hepatic disease; were pregnant or lactating; or had asthma.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoya Nishida |
Organization
Ehime University Hospital
Division name
Otolaryngology Head and Neck Surgery
Zip code
Address
Shitsukawa, Toon city, Ehime
TEL
089-956-3356
t.fujiwarabi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Fujiwara |
Organization
Ehime University Hospital
Division name
Otolaryngology Head and Neck Surgery
Zip code
Address
Shitsukawa, Toon city, Ehime
TEL
089-956-3356
Homepage URL
t.fujiwarabi@gmail.com
Sponsor or person
Institute
Department of Otolaryngology Head and Neck Surgery, Ehime University Hospital
Institute
Department
Personal name
Funding Source
Organization
Maruha Nichiro
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
愛媛大学病院（愛媛県）
Ehime University Hospital (Ehime Prefecture)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 28 | Day |
Last modified on
| 2016 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014474
