Actively Recruiting
Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis
Led by Beijing Chest Hospital · Updated on 2024-05-08
292
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
Sponsors
B
Beijing Chest Hospital
Lead Sponsor
T
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is designed to further strengthen the clinical application evidence of BaidiZiyin Pill and ShenqiYifei Pill in the treatment of tuberculosis. To be included in the initial treatment of pulmonary tuberculosis patients, on the basis of standardized Western medicine treatment, BaidiZiyin Pills and ShenqiYifei Pills will be used to evaluate the clinical efficacy and safety of their products. 1. Evaluate the improvement of symptoms in the adjuvant treatment of newly treated pulmonary tuberculosis with BaidiZiyin Pill and ShenqiYifei Pill. 2. Explore the sputum negative conversion time and sputum negative conversion rate of BaidiZiyin Pill and ShenqiYifei Pill as adjunctive treatments for newly treated pulmonary tuberculosis. 3. Explore the protective effects of BaidiZiyin Pill and ShenqiYifei Pill on adverse reactions caused by chemotherapy.
CONDITIONS
Official Title
Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years, any gender
- Diagnosed with pulmonary tuberculosis following Chinese health industry standard WS 288-2017
- No prior anti-tuberculosis treatment or less than 1 week of HRZE treatment
- Voluntarily consent to participate with good medication compliance
- Meet traditional Chinese medicine criteria for Qi and Yin deficiency syndrome with specified main and secondary symptoms
You will not qualify if you...
- Received similar traditional Chinese medicine treatment within 4 weeks before enrollment
- Have drug-resistant or extensively drug-resistant pulmonary tuberculosis
- History or suspicion of allergies or severe adverse reactions to study drugs or their components
- Diagnosed with non-tuberculosis mycobacterial disease or repeated growth of non-tuberculosis mycobacteria
- Recurrent pulmonary tuberculosis with bacterial negative status or bacterial positive status with over one week of anti-tuberculosis treatment
- Have autoimmune diseases, cancer, severe blood diseases, epilepsy, or psychiatric disorders
- Severe cardiovascular or cerebrovascular diseases with NYHA classification III-IV
- Uncontrolled hypertension (blood pressure ≥ 160/100 mmHg)
- Poorly controlled diabetes
- Severe liver or kidney diseases or abnormal liver/kidney function tests
- Extrapulmonary tuberculosis types like lymph node, intestinal, bone, or nervous system tuberculosis
- Other lung diseases such as tumors, cysts, abscesses, interstitial lung disease, silicosis, or pneumoconiosis
- Pregnant or breastfeeding women
- HIV positive or syphilis antibody positive
- Participation in other clinical trials within the past 15 months
- History or suspicion of alcohol or drug abuse or drug dependence
- Deemed unsuitable for the trial by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Chest Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 101149
Actively Recruiting
Research Team
W
WENJUAN NIE, DR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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