UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Akamuku for seasonal allergic rhinitis; singlecenter double blind randomized control trial
Title of the study (Brief title)	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	Naoya Nishida
Organization	Ehime University Hospital
Division name	Otolaryngology Head and Neck Surgery
Address	Shitsukawa, Toon city, Ehime
TEL	089-956-3356
Email	t.fujiwarabi@gmail.com

Public contact
Name of contact person	Takashi Fujiwara
Organization	Ehime University Hospital
Division name	Otolaryngology Head and Neck Surgery
Address	Shitsukawa, Toon city, Ehime
TEL	089-956-3356
Homepage URL
Email	t.fujiwarabi@gmail.com

Sponsor
Institute	Department of Otolaryngology Head and Neck Surgery, Ehime University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014474