UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009920 |
|---|---|
| Receipt number | R000011622 |
| Scientific Title | Randomized controlled trial to evaluate anti-mycobacterial effects of Hochhu-ekkito add-on therapy for patients with pulmonary Mycobacterium avium complex disease intractable with or intolerant to conventional treatmnt |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2013/12/19 22:11:22 |
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Basic information
Public title
Randomized controlled trial to evaluate anti-mycobacterial effects of Hochhu-ekkito add-on therapy for patients with pulmonary Mycobacterium avium complex disease intractable with or intolerant to conventional treatmnt
Acronym
Randomized controlled trial to evaluate anti-mycobacterial effects of Hochhu-ekkito add-on therapy for patients with pulmonary Mycobacterium avium complex disease
Scientific Title
Randomized controlled trial to evaluate anti-mycobacterial effects of Hochhu-ekkito add-on therapy for patients with pulmonary Mycobacterium avium complex disease intractable with or intolerant to conventional treatmnt
Scientific Title:Acronym
Randomized controlled trial to evaluate anti-mycobacterial effects of Hochhu-ekkito add-on therapy for patients with pulmonary Mycobacterium avium complex disease
Region
| Japan |
Condition
Condition
Pulmonary Mycobacterium avium complex disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate anti-mycobacterial effects of Hochu-ekkito add-on therapy for patients with pulmonary Mycobacterium avium complex disease intractable with or intolerant to conventional treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sputum conversion rate over the six months treatment period
Key secondary outcomes
(1) Changes in images of chest X-ray
(2) Changes in the scores for quality of life and symptoms
(3) Changes in body weight
(4) Changes in biomarkers measured during treatment
(5) Evaluation of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment group:
Oral daily administration of Hochu-ekkito (5.0-7.5 g/day) plus the treatment currently performed at the time of registration. If the patients are not on any anti-mycobacterial chemotherapy, they will receive Hochu-ekkito alone.
Interventions/Control_2
Control group:
Continuation of the treatment currently performed at the time of registration. If the patients are not on any anti-mycobacterial chemotherapy, they will be observed without medication.
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
(1) Patients over 20 years old
(2) Patients who has been already diagnosed as having pulmonary mycobacterium avium complex disease at least one year ago
(3) Patients confirmed with positive sputum culture for mycobacterium avium complex within three months
(4) Patients who has been receiving conventional therapy for one year or more but intractable, or patients who had undergone conventional chemotherapy but become intolerant to it
(5) Patients who fulfill the recommended conditions for use of Hochu-ekkito: relatively declined physical strength, suffering from general fatigue and/or appetite loss.
Key exclusion criteria
(1) Patients with any malignant diseases
(2) Patients with interstitial lung diseases
(3) Patients whose regimen for anti-mycobacterai therapy had been changed within three months
(4) Patients who had been receiving any herbal drugs including Hochu-ekkito within three months
(5) Patients with severe other pulmonary diseases
(6) Pregnant women or females with childbearing potential
(7) Any other condition which, in the opinion of the investigator, would make the subject unsuitable for enrollment
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunori Enomoto |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Division of Respiratory Medicine
Zip code
Address
6-16-1 Tomioka-Higashi, Kanazawa-ku, Yokohama City 236-0051, Japan
TEL
045-701-9581
yasuyasuyasu29@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori Enomoto |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Division of Respiratory Medicine
Zip code
Address
6-16-1 Tomioka-Higashi, Kanazawa-ku, Yokohama City 236-0051, Japan
TEL
045-701-9581
Homepage URL
yasuyasuyasu29@yahoo.co.jp
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
神奈川県立循環器呼吸器病センター
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 01 | 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
| 2013 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
| 2013 | Year | 12 | Month | 19 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 31 | Day |
Last modified on
| 2013 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011622
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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| Registered date | File name |
