Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Chest Hospital
About this trial
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.
Eligibility criteria
Qualifiers
1. Age: 18 to 65 years old, regardless of gender;
2. Meets the diagnostic criteria for Western medicine pulmonary tuberculosis (formulated in accordance with the health industry standard WS 288-2017 "Diagnosis of Pulmonary Tuberculosis" of the People's Republic of China [9])
3. Have not received anti tuberculosis treatment in the past, or have received HRZE anti tuberculosis treatment for less than 1 week as a first-line option
4. The subjects themselves have informed consent, voluntarily participate in this study, have good medication compliance, and have signed the subject's informed consent form.
Disqualifiers
1. Patients who received similar traditional Chinese medicine treatment 4 weeks prior to enrollment;
2. Patients with drug-resistant and extensively drug-resistant pulmonary tuberculosis;
3. Known or suspected to have a history of allergies or serious adverse reactions to the investigational drug and its excipients, or allergic constitution.
4. Patients with drug sensitivity indicating the growth of non tuberculosis mycobacteria (more than twice) or clinically diagnosed with non tuberculosis mycobacterial disease or concomitant non tuberculosis mycobacterial disease;
Trial design
Treatments tested in this trial
- BaiDiZiYin Pill, ShenQiYiFei Pill
- Anti tuberculosis chemotherapy
Treatment groups
292 Participants
are divided into 2 treatment groupsSponsors and collaborators
Beijing Chest Hospital
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Shenyang Tenth People's Hospital
Collaborator
Lanzhou Pulmonary Hospital
Collaborator
Hebei Chest Hospital
Collaborator
Anhui Chest Hospital
Collaborator
Chongqing Public Health
Collaborator
Chengdu Public Health Clinical Center
Collaborator
Guangzhou Chest Hospital.
Collaborator
Third People's Court of Shenzhen
Collaborator
Heilongjiang Provincial Institute of Infectious Disease Prevention and Control
Collaborator
Wuhan tuberculosis Hospital
Collaborator
Suzhou Fifth Hospital
Collaborator
Source ClinicalTrials.gov