Evidence-based Evaluation and Mechanism of Shenhuang Granules in the Treatment of Sepsis

ConditionSepsis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Zhejiang Chinese Medical University

About this trial

Sepsis is a life-threatening organ dysfunction caused by the body's 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 Liangchun's 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old

Meet the diagnostic criteria of sepsis 3.0 guidelines

Sign informed consent.

Disqualifiers

Liver or kidney single SOFA score ≥3 points of liver and kidney dysfunction

Death is expected within 48 hours, or SOFA≥15 points, or APACHE II ≥30 points, or the patient refuses active treatment

Patients with allergic reactions to traditional Chinese medicine

Patients treated with chemotherapy or radiotherapy or high-dose immunosuppressants within the last 1 month

Trial design

Design model

Parallel

Treatments tested in this trial

  • shenhuang granule

    Drug

    Traditional Chinese medicine compound "Shenhuang Granules" is developed by Professor Fang Bangjiang, a scholar in the team of Qi-Huang, which is composed of ginseng, rhubarb, dandelion, etc., with the effect of Fuzheng Guben, clearing heat and detoxification, promoting qi and promoting blood and detumification.

  • placebo

    Drug

    Placebo was provided by Tianjin Hongri Pharmaceutical Co., LTD., and was given orally or nasally (through gastric tube or intestinal tube) after dissolution of 100ml warm water (temperature about 40°) in 1 package twice a day.

Treatment groups

410 Participants
are divided into 2 treatment groups
Group A: Treatment groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

28-day mortality rate

The proportion of deaths due to illness within 28 days after treatment began

Time frame
28-day

Secondary outcomes

1

Total length of stay and ICU stay

Total length of stay and length of stay in ICU

Time frame
7 day after treatment,14 day after treatment,28 day after treatment
2

Total hospitalization costs and ICU hospitalization costs

The patient's total hospitalization costs and hospitalization costs in the ICU

Time frame
7 day after treatment,14 day after treatment,28 day after treatment
3

Overall mortality and ICU mortality

The proportion of patients who died during their total hospital stay and the proportion of patients who died during their ICU stay were included

Time frame
7 day after treatment,14 day after treatment,28 day after treatment
4

28 days cumulative no mechanical ventilation time

The total time the patient spent without mechanical ventilation (such as a ventilator) in the 28 days following the start of treatment.

Time frame
28 day after treatment

Other outcomes

1

Blood routine test

It mainly includes WBC, percentage of neutrophils,The percentages of white blood cells and neutrophils represent inflammation, with higher values indicating higher inflammation.

Time frame
day 0,7 day after treatment
2

C-reactive protein

C-reactive protein on behalf of the inflammation, the higher the value, the higher the inflammatory conditions.

Time frame
day 0,7 day after treatment
3

Procalcitonin

Procalcitonin, the degree of its increase is positively correlated with the degree of infection. Used in the identification of bacteria and viruses, to monitor the severity of the infection, is used to evaluate the therapeutic effect and prognosis of infection.

Time frame
day 0,7 day after treatment
4

TNF-α

It is one of the cytokines involved in the inflammatory response and is used to evaluate the therapeutic effect and prognosis of infection.

Time frame
day 0,7 day after treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Zhejiang Chinese Medical University

Lead sponsor

Zhejiang University

Collaborator

Red Cross Hospital, Hangzhou, China

Collaborator

Ningbo Hospital of Traditional Chinese Medicine

Collaborator