UMIN-CTR Clinical Trial

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

seasonal allergic rhinitis

Classification by specialty

Clinical immunology

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

Email

t.fujiwarabi@gmail.com

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

Email

t.fujiwarabi@gmail.com

Institute

Department of Otolaryngology Head and Neck Surgery, Ehime University Hospital

Institute

Department

Personal name

Organization

Maruha Nichiro

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

愛媛大学病院（愛媛県）
Ehime University Hospital (Ehime Prefecture)

Date of disclosure of the study information

2014

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Published

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

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 related 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