AdjuvantPhase 4NCT06403943

Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis

A Phase 4 study testing BaiDiZiYin Pill, ShenQiYiFei Pill and Anti tuberculosis chemotherapy in people with Adjuvant and Treatment, run by Beijing Chest Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Adjuvant, Treatment, Tuberculosis
What is being tested?: BaiDiZiYin Pill, ShenQiYiFei Pill and Anti tuberculosis chemotherapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 292 participants
Where: 1 siteChina
Study dates: 29 May 2023to 31 Dec 2026
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Conforming to the diagnostic criteria for Qi and Yin deficiency syndrome in traditional Chinese medicine (in accordance with the industry standards of traditional Chinese medicine in the People's Republic of China - Traditional Chinese Medicine Internal Medicine - Diagnosis and Efficacy Criteria for Disease Symptoms ZY/T0011.1-94) Main symptoms: shortness of breath, fatigue, mental fatigue, weak pulse Secondary symptoms: hemoptysis, spontaneous sweating, night sweating, insufficient appetite, bloating, red and tender tongue, thin coating Diagnosis can be made by having two main symptoms and one secondary symptom.

Who cannot join

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;
5. For patients with recurrent pulmonary tuberculosis, those with bacterial negative pulmonary tuberculosis or those with initial bacterial positive pulmonary tuberculosis who have received anti tuberculosis treatment for more than one week;
6. Patients with combined autoimmune diseases, malignant tumors, severe hematological and hematopoietic system diseases, epilepsy, and psychiatric disorders;

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7. Concomitant severe organic cardiovascular and cerebrovascular diseases (such as congestive heart failure, myocardial infarction, and acute stroke with NYHA heart function grading of III-IV);
8. Merge uncontrolled hypertension (blood pressure ≥ 160/100mmHg at enrollment);
9. diabetes with poor glycemic control;
10. Concomitant severe liver and kidney diseases, or abnormal liver and kidney function tests (ALT, AST ≥ 2.5 times the upper limit of normal, Scr>the upper limit of normal);
11. Patients with extrapulmonary tuberculosis such as lymph node tuberculosis, intestinal tuberculosis, bone tuberculosis, renal tuberculosis, epididymal tuberculosis, urogenital tuberculosis, nervous system tuberculosis, and tuberculous meningitis;
12. Concomitant with other lung diseases, such as lung tumors, cysts, abscesses, interstitial lung disease, silicosis, pneumoconiosis, etc
13. Pregnant and lactating women;
14. HIV patients; Syphilis antibody positive patients;
15. Individuals who have participated in other clinical trials within 15.1 months;
16. Those who suspect or have a history of alcohol or drug abuse or a tendency towards drug dependence;
17. The researchers believe that patients are not suitable for inclusion in this trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

WENJUAN NIE, DR contact

+86 10 89509331 ext. 9331

94642975@qq.com

China1 site, 1 recruiting

Beijing Chest Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 101149
WENJUAN NIE, director, +86 10 89509331 ext. 9331, 94642975@qq.com
Recruiting

Other trials in China

About this study

Official title: 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

Evaluate the improvement of symptoms in the adjuvant treatment of newly treated pulmonary tuberculosis with BaidiZiyin Pill and ShenqiYifei Pill.
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.
Explore the protective effects of BaidiZiyin Pill and ShenqiYifei Pill on adverse reactions caused by chemotherapy.

Read the detailed description

Research drugs: Bai Di Zi Yin Wan and Shen Qi Yi Fei Wan.
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.
Study design: A randomized, controlled, multicenter clinical study.
Clinical staging: re evaluation after listing.
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
Being tested: BaiDiZiYin Pill, ShenQiYiFei Pill, Anti tuberculosis chemotherapy
Medical subject headings: Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BaiDiZiYin Pill, ShenQiYiFei PillDrug
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.
Anti tuberculosis chemotherapyDrug
Also called 2 months Isoniazid, Rifampicin, Ethambutol, Pyrazinamide （2HRZE）
2 months' intensive regimen of anti tuberculosis chemotherapy Recommended first-line anti tuberculosis regimen: 2HRZE

Study groups in NCT06403943
Study group	Role	What they receive
Experimental group	Experimental	BaidiZiyin Wan and ShenqiYifei Wan are traditional Chinese medicines. Used as an adjuvant therapy for pulmonary tuberculosis. It is mainly used to improve the symptoms of tuberculosis (including fever, cough, expectoration, blood sputum or hemoptysis, anorexia, chest pain, emaciation, night sweats). Receives: Drug: BaiDiZiYin Pill, ShenQiYiFei Pill; Drug: Anti tuberculosis chemotherapy
Control group	Active comparator	2 months' intensive regimen of anti tuberculosis chemotherapy Recommended first-line anti tuberculosis regimen: 2HRZE Receives: Drug: Anti tuberculosis chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 May 202331 Dec 2026

First posted8 May 2024
Study start29 May 2023
Primary completion31 Oct 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AdjuvantStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 292 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06403943
Sponsor's protocol ID: BJCH-20240329
Status last verified: May 2024
First submitted: 28 Mar 2024
Last updated: 8 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Interested in taking part?

WENJUAN NIE, DR

+86 10 89509331 ext. 9331

94642975@qq.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06403943
Acronym / sponsor ID: BJCH-20240329
Conditions: Adjuvant, Treatment, Tuberculosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 292 participants (estimated)
Lead sponsor: Beijing Chest HospitalUniversity, hospital or other
Collaborators: The First Affiliated Hospital with Nanjing Medical University, Shenyang Tenth People's Hospital, Lanzhou Pulmonary Hospital, Hebei Chest Hospital, Anhui Chest Hospital, Chongqing Public Health, Chengdu Public Health Clinical Center, Guangzhou Chest Hospital., Third People's Court of Shenzhen, Heilongjiang Provincial Institute of Infectious Disease Prevention and Control, Wuhan tuberculosis Hospital, Suzhou Fifth Hospital
Study start: 29 May 2023 (actual)
Primary completion: 31 Oct 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 8 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluate the improvement of symptoms in the adjuvant treatment of newly treated pulmonary tuberculosis with BaidiZiyin Pill and ShenqiYifei Pill.
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.
Explore the protective effects of BaidiZiyin Pill and ShenqiYifei Pill on adverse reactions caused by chemotherapy.

Detailed description

Research drugs: Bai Di Zi Yin Wan and Shen Qi Yi Fei Wan.
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.
Study design: A randomized, controlled, multicenter clinical study.
Clinical staging: re evaluation after listing.
Treatment plan:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental group	Experimental	Drug: BaiDiZiYin Pill, ShenQiYiFei Pill, Drug: Anti tuberculosis chemotherapyBaidiZiyin Wan and ShenqiYifei Wan are traditional Chinese medicines. Used as an adjuvant therapy for pulmonary tuberculosis. It is mainly used to improve the symptoms of tuberculosis (including fever, cough, expectoration, blood sputum or hemoptysis, anorexia, chest pain, emaciation, night sweats).
Control group	Active comparator	Drug: Anti tuberculosis chemotherapy2 months' intensive regimen of anti tuberculosis chemotherapy Recommended first-line anti tuberculosis regimen: 2HRZE

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.
Conforming to the diagnostic criteria for Qi and Yin deficiency syndrome in traditional Chinese medicine (in accordance with the industry standards of traditional Chinese medicine in the People's Republic of China - Traditional Chinese Medicine Internal Medicine - Diagnosis and Efficacy Criteria for Disease Symptoms ZY/T0011.1-94) Main symptoms: shortness of breath, fatigue, mental fatigue, weak pulse Secondary symptoms: hemoptysis, spontaneous sweating, night sweating, insufficient appetite, bloating, red and tender tongue, thin coating Diagnosis can be made by having two main symptoms and one secondary symptom.

Key exclusion criteria (17 listed)

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;
5. For patients with recurrent pulmonary tuberculosis, those with bacterial negative pulmonary tuberculosis or those with initial bacterial positive pulmonary tuberculosis who have received anti tuberculosis treatment for more than one week;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BaiDiZiYin Pill, ShenQiYiFei PillIndications 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	Experimental group
Anti tuberculosis chemotherapyAlso: 2 months Isoniazid, Rifampicin, Ethambutol, Pyrazinamide （2HRZE）2 months' intensive regimen of anti tuberculosis chemotherapy Recommended first-line anti tuberculosis regimen: 2HRZE	Drug	Control group, Experimental group

Primary outcome

Primary Outcome: Improvement of symptoms
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).
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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

WENJUAN NIE, DR contact

+86 10 89509331 ext. 9331

94642975@qq.com

WENJUAN NIE, DR study director

Beijing Chest Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BaiDiZiYin Pill, ShenQiYiFei Pill and Anti tuberculosis chemotherapy in people with Adjuvant and Treatment, run by Beijing Chest Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact WENJUAN NIE, DR (+86 10 89509331 ext. 9331, 94642975@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome: Improvement of symptoms (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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06403943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.