Prevention of Recurrence With Cordyceps Sinensis in Mycobacterium Avium Complex Pulmonary Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBin Cao
About this trial
The goal of this clinical trial is to learn if cordyceps sinesis capsule (Bailiing Capsule) works to prevent the recurrence of microbiologically cured mycobacterium avium complex pulmonary disease in adults. The main questions it aims to answer are:
Does cordyceps sinesis capsule (Bailiing Capsule) prevents the recurrence of mycobacterium avium complex pulmonary disease in adults? Researchers will compare cordyceps sinesis capsule (Bailiing Capsule) to a placebo (a look-alike substance that contains no drug) to see if cordyceps sinesis capsule helps to prevent the recurrence of mycobacterium avium complex pulmonary disease.
Participants will:
Take cordyceps sinesis capsule (Bailiing Capsule) or a placebo (a look-alike substance that contains no drug) for 12 months, both are administered every day.
Visit the clinic once every 3 months for checkups and tests. Take online questionnaires every month.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients voluntarily participate in the study and sign the informed consent form.
Age between 18 and 75 years, inclusive; gender unrestricted.
Confirmed diagnosis of MAC (Mycobacterium avium complex) lung disease according to either the 2020 ATS/IDSA guidelines or the Chinese Guideline for Diagnosis and Treatment of Nontuberculous Mycobacterial Disease (2020 edition). Imaging findings at baseline must show a nodular bronchiectatic pattern prior to treatment initiation.
Completed the recommended treatment regimen for nodular-bronchiectatic MAC lung disease (macrolide + ethambutol + rifampin, with minimum 12-month duration) per the above guidelines within 3 months prior to screening; Fully completed the anti-infective treatment phase of this study. Participants must achieve bacteriologic negativity (two consecutive negative sputum cultures with an interval ≥4 weeks) by the end of their treatment course.
Disqualifiers
Any allergy to drugs included in the treatment regimen.
Completed anti-MAC therapy for more than 3 months.
Active respiratory tract infection.
Presence of congenital/acquired immunodeficiency diseases, active pulmonary malignancies (primary or metastatic), or any malignant tumors requiring chemotherapy/radiotherapy during screening or the study period.
Trial design
Design model
Parallel
Treatments tested in this trial
cordyceps sinesis capsule
Drugcordyceps sinesis capsule 4 capsules tid po for 12 months
cordyceps sinesis capsule placebo
Drugcordyceps sinesis capsule placebo 4 capsules tid po for 12 months
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Cordyceps sinesisExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
bacterial recurrence of MAC-PD
Time frame
from enrollment to the end of month 12Secondary outcomes
1
occurrence of respiratory infection
Time frame
from enrollment to the end of month 12Other outcomes
1
adverse events and laboratory findings
Time frame
from enrollment to the end of month 122
recurrent MAC strain subtype
Time frame
from enrollment to the end of month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bin Cao
Lead sponsor
Capital Medical University
Sponsor institution
China-Japan Friendship Hospital
Collaborator
Shanghai Pulmonary Hospital, Shanghai, China
Collaborator
Jiangxi Chest Hospital
Collaborator
Guangzhou Chest Hospital.
Collaborator
Anhui Chest Hospital
Collaborator
Beijing Chest Hospital
Collaborator
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov