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Tests treatment safety and results for Adjuvant
Official title Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis
ClinicalTrials.gov ID: NCT06403943
What this study is testing
What is BaiDiZiYin Pill, ShenQiYiFei Pill?
BaiDiZiYin Pill, ShenQiYiFei Pill is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for adjuvant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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...
- 4\. The people themselves have informed consent, voluntarily participate in this study, have good medication compliance, and have signed the...
You likely can't join if
- 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...
- 4\. Patients with drug sensitivity indicating the growth of non tuberculosis mycobacteria (more than twice) or clinically diagnosed with non...
- 5\. For patients with recurrent pulmonary tuberculosis, those with bacterial negative pulmonary tuberculosis or those with initial bacterial positive...
- 6\. Patients with combined autoimmune diseases, malignant tumors, severe hematological and hematopoietic system diseases, epilepsy, and psychiatric...
See the full eligibility criteria
- 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...
- 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 people 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...
- 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...
- 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...
- 6\. Patients with combined autoimmune diseases, malignant tumors, severe hematological and hematopoietic system diseases, epilepsy, and psychiatric disorders;
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.