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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
BaiDiZiYin Pill, ShenQiYiFei Pill
DrugIndications of BaidiZiyin Pill: Nourishing the lungs and kidneys, cooling blood and removing steam. Used as an adjunctive treatment for tuberculosis caused by lung and kidney deficiency and qi yin injury, including coughing, shortness of breath, dry cough with less phlegm, hot flashes and night sweats, cold and spontaneous sweating, hoarseness, palpitations, cold limbs, and emaciation. Indications of ShenqiYifei Pill: expectorant and cough relieving. It is suitable for patients with pulmonary tuberculosis and spleen diseases, as well as phlegm dampness retention. Symptoms include short breath, low sound, clear and thin phlegm, limited appetite, bloating and loose stools, pale complexion, fatigue and chest tightness, emaciation, and fear of cold and spontaneous sweating.
Anti tuberculosis chemotherapy
Drug2 months' intensive regimen of anti tuberculosis chemotherapy Recommended first-line anti tuberculosis regimen: 2HRZE
Treatment groups
292 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Outcome: Improvement of symptoms
The change rate of symptoms and the overall clinical symptom score of pulmonary tuberculosis. The following indicators are divided into: none (0 points); Light (1 point); Medium (2 points); Heavy (3 points). Fatigue: None; Labor leads to fatigue; If you move, you will feel tired; Not moving is also lacking. Hemoptysis: None; Occasional hemoptysis or sputum with blood streaks; Occasional or minor hemoptysis; Frequent or moderate to massive hemoptysis. Cough: None; Intermittent coughing during the day does not affect work and life; Can persist in working despite coughing during the day or occasional coughing at night; Frequent coughing or working during the day and night can affect work and life. Phlegm: None; Cough 10-15ml of phlegm day and night; Cough 50-100ml of phlegm day and night; Coughing more than 100ml day and night. Chest pain: None; Mild chest pain; Chest pain is obvious but tolerable; Chest pain significantly affects respiratory cough.
Time frame
The Time Frame is 2 months. After 2 months, the following indicators are divided into: none (0 points); Light (1 point); Medium (2 points); Heavy (3 points).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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