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

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 - Randomized controlled trial to evaluate anti-mycobacterial effects of Hochhu-ekkito add-on therapy for patients with pulmonary Mycobacterium avium complex disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009920

Enrollment

Registered

2013-02-01

Start date

2013-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Mycobacterium avium complex disease

Interventions

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 chem

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Sputum conversion rate over the six months treatment period	—

Secondary

Measure	Time frame
(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	—

Countries

Japan

Contacts

Public ContactYasunori Enomoto

Kanagawa Cardiovascular and Respiratory Center Division of Respiratory Medicine

yasuyasuyasu29@yahoo.co.jp045-701-9581

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026