NCT06403943

Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis

A Randomized, Controlled, Multicenter Clinical Study on the Efficacy and Safety of BaiDiZiYin Pill and ShenQiYiFei Pill as Adjunctive Treatments for Newly Diagnosed Pulmonary Tuberculosis Patients

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 292 (estimated)
• Sponsor: Beijing Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Adjuvant
• Treatment
• Tuberculosis

Interventions

Type	Name	Description
DRUG	BaiDiZiYin Pill, ShenQiYiFei Pill	Indications 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.
DRUG	Anti tuberculosis chemotherapy	2 months' intensive regimen of anti tuberculosis chemotherapy Recommended first-line anti tuberculosis regimen: 2HRZE

Timeline

• Start date: 2023-05-29
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2024-05-08
• Last updated: 2024-05-08

Locations

1 site across 1 country: China