UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001653 |
|---|---|
| Receipt number | R000001994 |
| Scientific Title | A non-blind, randomized, parallel group comparative trial to study the efficacy and safety of Mao-to in the treatment of influenza. |
| Date of disclosure of the study information | 2009/01/23 |
| Last modified on | 2010/03/26 09:45:17 |
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Basic information
Public title
A non-blind, randomized, parallel group comparative trial to study the efficacy and safety of Mao-to in the treatment of influenza.
Acronym
Exploratory evaluation of the efficacy and safety of Mao-to in the treatment of influenza.
Scientific Title
A non-blind, randomized, parallel group comparative trial to study the efficacy and safety of Mao-to in the treatment of influenza.
Scientific Title:Acronym
Exploratory evaluation of the efficacy and safety of Mao-to in the treatment of influenza.
Region
| Japan |
Condition
Condition
Influenza Type A and Type B
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Mao-to in the treatment of influenza by comparing residual virus, influenza symptoms and cytokine levels over time with well established antiviral agents.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
1.Viral tests
(1) Residual virus
"Nasal swab" will be taken on Day 1, 3, and 5 (or discontinuation date) to conduct the following tests: (If sinuses are too dry for sample collection, throat swabs may be substituted. Day 6 samples will be accepted if subjects are not available or if a holiday coincides with Day 5.)
* Viral isolation and identification (PCR)
* Rapid diagnostic test for influenza (Day 3, Day 5 (or discontinuation date))
2. Influenza symptoms
(1) Time of fever clearance
Instruct subjects to record their body temperature from the start date of administration (Day 1) to Day 5. Fever clearance time is measured as the time from drug administration until the reduction of body temperature below 37.5C. (If the temperature relapses above 37.5C, fever clearance time will be considered as the last time it took for the body temperature to drop below 37.5C).
(2) Other symptoms
Instruct subjects to keep a symptom diary from the start date of administration (Day 1) until Day 5 (or discontinuation date):
* nasal discharge, nasal obstruction, sore throat, muscle ache, joint pain, malaise or fatigue, and headache.
3) Blood count, CRP and cytokine
(1) Changes in cytokine levels
Determine the blood count (WBC fraction), CRP, cytokine (IL-1, IL-6, IL-8, IL-10, TNF-a, IFNa2) levels in the blood from the start date (Day 1, prior to test drug administration), Day 3, and Day 5 (or discontinuation date).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Test drug: Tsumura Mao-to extract granule for prescription
Normal adult dose: 7.5g PO divided BID/TID before or between meals.
Duration of administration: 5 days
Interventions/Control_2
Test drug: oseltamivir phosphate (product name: Tamiflu capsule 75)
Standard dosage for adults and children with body weight of > 37.5kg: 1 cap (75mg) PO BID x 5 days.
Interventions/Control_3
Zanamivir (product name: Relenza)
Standard dosage for adults and children: 10mg (5mg blisters of powders x 2) BID x 5 days on a ROTADISK® for oral inhalation via DISKHALER®.
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
1) Positive rapid diagnostic test for influenza.
2) Fever >= 38.0C upon admission, or fever >= 37.5C upon admission with a history of fever >= 38.0C within 4 hours prior to admission.
3) Within 48 hours after onset of influenza symptoms.
4) Age: between 20-65 yrs (at the time of signing informed consent)
5) Gender: unspecified
6) Consultation method: outpatient
7) Provision of a signed informed consent.
Key exclusion criteria
1) Administration of Kampo medicine or any respiratory medication within 3 days prior to registration.
2) Administration of influenza vaccination within 2 weeks prior to registration.
3) Serious disease complication including, but not limited to: liver, kidney, heart, lung, circulatory, or metabolic disorder.
4) Suspicion of supervening bacterial infection of the respiratory tract.
5) History of drug allergies.
6) Females who are pregnant, lactating or planning pregnancy.
7) Administration of another investigational drug within 4 weeks prior to registration or during the study period, or planned participation in another study.
8) Contraindications to acetaminophen (peptic ulcer, aspirin-induced asthma, acetaminophen hypersensitivity).
9) Subjects who are unfit for the study as judged by the research director, research staff, or others (referred to as "research director and team")
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeki Nabeshima |
Organization
Fukuoka University Hospital
Division name
General medicine
Zip code
Address
45-1 7-chome Nanakuma Jonan-ku, Fukuokashi Fukuoka-ken 814-0180
TEL
092-801-1011
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Fukuoka University Hospital
Division name
General medicine
Zip code
Address
45-1 7-chome Nanakuma Jonan-ku, Fukuokashi Fukuoka-ken 814-0180
TEL
092-801-1011
Homepage URL
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsumura & Co.
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 01 | Month | 23 | 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
| 2008 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 23 | Day |
Last modified on
| 2010 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001994
