Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514339
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-19
Brief Title:
Evidence-based Evaluation and Mechanism of Shenhuang Granules in the Treatment of Sepsis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evidence-based Evaluation and Mechanism of Shenhuang Granules in the Treatment of Sepsis a Randomized Double-blind Placebo-controlled Effective Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sepsis is a life-threatening organ dysfunction caused by the bodys dysfunctional response to infection most patients require treatment in the ICU and is the leading cause of death worldwide Over the years the development of new drugs for the treatment of sepsis has failed without significant benefit in reducing mortality and there is currently no effective drug treatment Therefore sepsis is a serious disease threatening the life and health of patients causing a huge burden to society and is a major problem in the medical field
The pathogenesis of sepsis is complicated and immune imbalance is the key mechanism Suppression of host immune function may be the root cause of the increase in the long-term mortality of sepsis Bidirectional immune regulation may be an important treatment plan to improve the survival rate and quality of life of sepsis patients In recent years the contribution of traditional Chinese medicine to sepsis has been highly valued at home and abroad The treatment of sepsis by traditional Chinese medicine mainly plays the role of bidirectional immune regulation by dispelling the evil and supporting the right Our team has achieved some results in the diagnosis and treatment of sepsis by using traditional Chinese medicine Supported by National Natural Science Foundation of China 81774070 The team also found that magnolol can inhibit intestinal mucosal inflammation in sepsis which was also supported by the National Natural Science Foundation of China 82174178 The team of Qhuang scholars inherit the academic experience of Zhu Liangchun the master of Chinese medicine warm and hot disease need not be limited to the law of wei qi ying blood transmission that is the disease can be solved both outside and inside breaking the three bans of warm and cold disease On the basis of inheriting Zhu Liangchuns academic theory the author put forward the early treatment rule of truncation and reversal and used to cleanse the poison and save Yin in the early stage of sepsis to quickly truncate the malignant development trend of sepsis In the COVID-19 epidemic we have found that patients with COVID-19 sepsis have acute deficiency syndrome in the early stage of clinical syndrome which is an important factor leading to death The clinical efficacy and mechanism of Shenhuang Granules in sepsis caused by non-novel coronavirus infection such as bacteria need to be further studied
The pathogenesis of sepsis is complicated and immune imbalance is the key mechanism Suppression of host immune function may be the root cause of the increase in the long-term mortality of sepsis Bidirectional immune regulation may be an important treatment plan to improve the survival rate and quality of life of sepsis patients In recent years the contribution of traditional Chinese medicine to sepsis has been highly valued at home and abroad The treatment of sepsis by traditional Chinese medicine mainly plays the role of bidirectional immune regulation by dispelling the evil and supporting the right Our team has achieved some results in the diagnosis and treatment of sepsis by using traditional Chinese medicine Supported by National Natural Science Foundation of China 81774070 The team also found that magnolol can inhibit intestinal mucosal inflammation in sepsis which was also supported by the National Natural Science Foundation of China 82174178 The team of Qhuang scholars inherit the academic experience of Zhu Liangchun the master of Chinese medicine warm and hot disease need not be limited to the law of wei qi ying blood transmission that is the disease can be solved both outside and inside breaking the three bans of warm and cold disease On the basis of inheriting Zhu Liangchuns academic theory the author put forward the early treatment rule of truncation and reversal and used to cleanse the poison and save Yin in the early stage of sepsis to quickly truncate the malignant development trend of sepsis In the COVID-19 epidemic we have found that patients with COVID-19 sepsis have acute deficiency syndrome in the early stage of clinical syndrome which is an important factor leading to death The clinical efficacy and mechanism of Shenhuang Granules in sepsis caused by non-novel coronavirus infection such as bacteria need to be further studied
Detailed Description:
1 Baseline data patients name gender age enrollment diagnosis sepsis diagnosis time combined underlying disease allergy history personal history body temperature respiration heart rate blood pressure blood oxygen saturation and other vital signs
2 Primary outcome measure 28-day mortality
3 Secondary outcome indicators
A Total length of stay and ICU stay B Total hospitalization costs and ICU hospitalization costs C Overall mortality and ICU mortality D28 days cumulative no mechanical ventilation time E Information of TCM syndrome such as tongue and pulse on day 0 and day 5-7 F TCM symptom scores on days 0 and 5-7 G SOFA score and APACHE II score on days 0 and 5-7
4 Other observation indicators day 0 and 7
A Inflammatory markers WBC percentage of neutrophils CRP PCT tumor necrosis factor TNF-α interleukin-6 IL-6 interleukin-10 IL-10 B Main organ function indicators BNP TnI creatinine urea nitrogen total bilirubin direct bilirubin indirect bilirubin AST ALT arterial lactic acid C Coagulation indicators PT APTT D Immune function absolute number of lymphocytes number of CD4T cells number of CD8T cells number of B cells number of NK cells
5 Safety indicators adverse reaction symptoms or adverse events such as allergies
If you need to collect stool and blood samples you also need to observe the following indicators if not please ignore
6 Metabolomic study Serum samples from day 0 and day 5-7 were collected for the study of the main functional components of Shenhuang granules and metabolomic analysis
7 Intestinal microecology study Stool samples from day 0 and day 5-7 were collected for intestinal microecology study
2 Primary outcome measure 28-day mortality
3 Secondary outcome indicators
A Total length of stay and ICU stay B Total hospitalization costs and ICU hospitalization costs C Overall mortality and ICU mortality D28 days cumulative no mechanical ventilation time E Information of TCM syndrome such as tongue and pulse on day 0 and day 5-7 F TCM symptom scores on days 0 and 5-7 G SOFA score and APACHE II score on days 0 and 5-7
4 Other observation indicators day 0 and 7
A Inflammatory markers WBC percentage of neutrophils CRP PCT tumor necrosis factor TNF-α interleukin-6 IL-6 interleukin-10 IL-10 B Main organ function indicators BNP TnI creatinine urea nitrogen total bilirubin direct bilirubin indirect bilirubin AST ALT arterial lactic acid C Coagulation indicators PT APTT D Immune function absolute number of lymphocytes number of CD4T cells number of CD8T cells number of B cells number of NK cells
5 Safety indicators adverse reaction symptoms or adverse events such as allergies
If you need to collect stool and blood samples you also need to observe the following indicators if not please ignore
6 Metabolomic study Serum samples from day 0 and day 5-7 were collected for the study of the main functional components of Shenhuang granules and metabolomic analysis
7 Intestinal microecology study Stool samples from day 0 and day 5-7 were collected for intestinal microecology study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None