Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

1. Research drugs: Bai Di Zi Yin Wan and Shen Qi Yi Fei Wan. 2. Research objective: To evaluate the symptom improvement of Baidi Ziyin Pill and Shenqi Yifei Pill in the adjuvant treatment of newly treated pulmonary tuberculosis; Explore the sputum negative conversion time and sputum negative conversion rate of Baidi Ziyin Pill and Shenqi Yifei Pill as adjunctive treatments for newly treated pulmonary tuberculosis; Explore the protective effects of Baidi Ziyin Pill and Shenqi Yifei Pill on adverse reactions caused by chemotherapy. 3. Study design: A randomized, controlled, multicenter clinical study. 4. Clinical staging: re evaluation after listing. 5. Treatment plan: Experimental group: Take Bai Di Zi Yin Wan in the morning, 45 pills per time; Take 45 pills of Shenqi Yifei Pill per time at night, combined with a first-line anti tuberculosis regimen of 2HRZE Control group: Antituberculosis chemotherapy Recommended frontline anti tuberculosis regimen: 2HRZE Isoniazid (0.3g), rifampicin (0.45g for weight 50kg and below, 0.6g for weight 50kg and above), pyrazinamide (1.5g), ethambutol (0.75g for weight 50kg and below, 1.0g for weight 50kg and above), once a day, for a course of 8 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06403943
Study type	Interventional
Source	Beijing Chest Hospital
Contact	WENJUAN NIE, DR
Phone	+86 10 89509331
Email	94642975@qq.com
Status	Recruiting
Phase	Phase 4
Start date	May 29, 2023
Completion date	December 31, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms