Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403943
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-28
Brief Title:
Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis
Sponsor:
Beijing Chest Hospital
Organization:
Beijing Chest Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 03g rifampicin 045g for weight 50kg and below 06g for weight 50kg and above pyrazinamide 15g ethambutol 075g for weight 50kg and below 10g for weight 50kg and above once a day for a course of 8 weeks
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 03g rifampicin 045g for weight 50kg and below 06g for weight 50kg and above pyrazinamide 15g ethambutol 075g for weight 50kg and below 10g for weight 50kg and above once a day for a course of 8 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None