Prevention of Recurrence With Cordyceps Sinensis in Mycobacterium Avium Complex Pulmonary Disease

NCT07174076 | Recruiting Phase 4

• 1 other identifier: 2025-KY-004-1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Mycobacterium Avium Complex Pulmonary Disease

Keywords

mycobacerium avium complex; recurrence; cordyceps sinesis

Outcome Measures

Primary Outcomes (1)

• bacterial recurrence of MAC-PD

  from enrollment to the end of month 12

Secondary Outcomes (1)

• occurrence of respiratory infection

  from enrollment to the end of month 12

Other Outcomes (2)

• adverse events and laboratory findings

  from enrollment to the end of month 12

• recurrent MAC strain subtype

  from enrollment to the end of month 12

Study Arms (2)

Cordyceps sinesis

EXPERIMENTAL

cordyceps sinesis capsule 4# tid for 12 months

Drug: cordyceps sinesis capsule

Placebo

PLACEBO COMPARATOR

placebo 4# tid for 12 months

Drug: cordyceps sinesis capsule placebo

Interventions

cordyceps sinesis capsule DRUG

cordyceps sinesis capsule 4 capsules tid po for 12 months

Cordyceps sinesis

cordyceps sinesis capsule placebo DRUG

cordyceps sinesis capsule placebo 4 capsules tid po for 12 months

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• For non-surgically sterilized women of childbearing potential:
• Must use a medically approved contraceptive method (e.g., intrauterine device, hormonal contraceptives, or condoms) during the study period and for 3 months post-last treatment dose. A negative serum/urine pregnancy test must be confirmed within 72 hours prior to enrollment.
• Must not be lactating at screening.
• For male participants with partners of childbearing potential:
• Must use effective contraception during the study and for 3 months post-last treatment dose.
• Organ Function Requirements (Met Within 1 Week Prior to Enrollment):
• i. Hemoglobin ≥60 g/L; ii. Neutrophil count ≥0.5 × 10⁹/L; iii. Platelet count ≥60 × 10⁹/L; iv. Serum total bilirubin ≤3× upper limit of normal (ULN); v. Aspartate aminotransferase (AST) ≤3× ULN; vi. Alanine aminotransferase (ALT) ≤3× ULN; vii. Serum creatinine \<2× ULN or creatinine clearance ≥60 mL/min; viii. Blood urea nitrogen (BUN) ≤200 mg/L; ix. Urine protein \<++ on dipstick; if trace (+), 24-hour urine protein must be \<500 mg; x. Fasting glucose within normal range \*\*or\*\* controlled stable glycemic levels in diabetic patients; xi. Cardiac function: No myocardial infarction in the past 6 months, no unstable angina, no severe arrhythmias, and New York Heart Association (NYHA) functional class ≤II.

You may not qualify if:

• 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.
• History of solid organ transplantation.
• Currently undergoing dialysis.
• Radiographic pneumonia requiring steroid/immunoglobulin pulse therapy, clinically evident active interstitial lung disease, uncontrolled massive pleural effusion/pericardial effusion.
• Unstable concomitant systemic diseases (hypertensive crisis, unstable angina, congestive heart failure, myocardial infarction within the past 6 months, severe psychiatric disorders requiring medication, severe hepatic/renal dysfunction, neurodegenerative diseases such as Alzheimer's disease).
• Poor gastrointestinal function or malabsorption syndrome.
• Receipt of other investigational drugs (excluding participation of 2025-KY-004-1) within 4 weeks prior to the first administration of study drug.
• Participation in another interventional clinical trial simultaneously, except for observational/non-interventional trials or follow-up periods of interventional trials.
• Any physical examination findings or clinical laboratory results that the investigator believes may interfere with study outcomes or pose increased risks of complications for the patient's management.

Sponsors & Collaborators

• Bin Cao: lead
• 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

Study Sites (6)

Anhui Chest Hospital

Hefei, Anhui, China

RECRUITING

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

Guangzhou Chest Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

Jiangxi Chest Hospital

Nanchang, Jiangxi, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaojing Cui, M.D.

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siwei Gu, M.D.

CONTACT

+86 010 84205566; orbitline2@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: September 15, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): July 24, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)