UMIN-CTR Clinical Trial

Public title

Non-randomized, multicenter, open, fixed-dose, single group, joint study to determine the efficacy and safety of Maoto for Influenza Type A

Acronym

To explore and evaluate the efficacy and safety of Maoto for Influenza Type A

Scientific Title

Non-randomized, multicenter, open, fixed-dose, single group, joint study to determine the efficacy and safety of Maoto for Influenza Type A

Scientific Title:Acronym

To explore and evaluate the efficacy and safety of Maoto for Influenza Type A

Region

Japan

Condition

Influenza Type A

Classification by specialty

Pneumology

Infectious disease

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To explore the efficacy of Maoto against Influenza Type A by evaluating fever clearance time, residual viral load, symptom changes, and concurrently collecting data about its safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase IV

Primary outcomes

1) Symptoms of Influenza
a.fever clearance time
b.other symptoms (nasal discharge, nasal obstruction, sore throat, cough, muscle ache, arthralgia, lethargy or fatigue, headache)
2) Laboratory test for virus

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Test drug: Tsumura Mao-to extract granule for prescription
Normal adult dose is 7.5g p.o. in 2-3 divided doses, before or between meals.
Duration of administration: 5 days

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

Age-lower limit

10

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Patients with a fever >38.0C or >37.5C at the time of admission, or >38.0C within 4 hours of admission
2) Patients who tested positive on Rapid Influenza Type A Diagnostic Test
3) Patients with influenza symptoms within 48 hours of onset
4) Age: between 10 - 65 y/o (at the time of acquisition of consent)
5) Gender: no specification
6) Consultation method: outpatient
7) Patients who can provide written informed consent ,if the patient is a minor, informed consent must be obtained from the patient and legal representative.

Key exclusion criteria

1) Patients who were taking Kampo or medication for respiratory disease within 3 days of registration
2) Patients who obtained an influenza vaccination within 2 weeks of registration
3) Patients with serious complications (liver, kidney, heart, lung, circulatory, or metabolic disorder)
4) Patients suspected of concomitant bacterial infection of the respiratory system
5) Patients with a history of drug allergy
6) Patients who are nursing, pregnant or desiring conception
7) Patients who are currently taking a test drug or planning to partake in a clinical trial
8) Patients with contraindication for acetaminophen (peptic ulcer, aspirin-induced asthma, acetaminophen hypersensitivity)
9) Patients who are considered inappropriate by the research director, research staff, or others (referred collectively as research director, etc.)

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Norio Iwaki

Organization

Iwaki internal medicine clinic

Division name

directer

Zip code

Address

2-5-20,Ekinishihonmachi Kanazawa-shi, Ishikawa-ken,Japan

TEL

076-223-2111

Email

Name of contact person

1st name
Middle name
Last name	Norio Iwaki

Organization

Iwaki internal medicine clinic

Division name

directer

Zip code

Address

2-5-20,Ekinishihonmachi Kanazawa-shi, Ishikawa-ken,Japan

TEL

076-223-2111

Homepage URL

Email

iwaki@po2.nsknet.or.jp

Institute

TJ-27 Influenza study group

Institute

Department

Personal name

Organization

Tsumura & Co.

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

群馬県、石川県、岐阜県、徳島県、熊本県、兵庫県

Date of disclosure of the study information

2010

Year

03

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

2009

Year

11

Month

06

Day

Date of IRB

Anticipated trial start date

2009

Year

12

Month

01

Day

Last follow-up date

2010

Year

05

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

03

Month

24

Day

Last modified on

2010

Year

11

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004091