UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009920
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yasuyasuyasu29@yahoo.co.jp

Sponsor
Institute Kanagawa Cardiovascular and Respiratory Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011622

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.