Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis

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.

Conditions

• Adjuvant
• Treatment
• Tuberculosis

Interventions

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Shenyang Tenth People's Hospital

  collaborator OTHER

• Lanzhou Pulmonary Hospital

  collaborator UNKNOWN

• Hebei Chest Hospital

  collaborator UNKNOWN

• Anhui Chest Hospital

  collaborator OTHER

• Chongqing Public Health

  collaborator UNKNOWN

• Chengdu Public Health Clinical Medical Center

  collaborator UNKNOWN

• Guangzhou Chest Hospital.

  collaborator UNKNOWN

• Third People's Court of Shenzhen

  collaborator UNKNOWN

• Heilongjiang Provincial Institute of Infectious Disease Prevention and Control

  collaborator UNKNOWN

• Wuhan tuberculosis Hospital

  collaborator UNKNOWN

• Suzhou Fifth Hospital

  collaborator UNKNOWN

• Beijing Chest Hospital

  lead OTHER

Principal Investigators

• WENJUAN NIE, DR · Beijing Chest Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-29

Primary Completion

2026-10-31

Completion

2026-12-31

Countries

• China

Study Locations