Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06514339

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

Led by The First Affiliated Hospital of Zhejiang Chinese Medical University · Updated on 2025-08-22

410

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital of Zhejiang Chinese Medical University

Lead Sponsor

Z

Zhejiang University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Meet the diagnostic criteria of sepsis 3.0 guidelines
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Liver or kidney SOFA score 3 points or higher indicating severe dysfunction
  • Expected death within 48 hours, SOFA score 15 or higher, APACHE II score 30 or higher, or refusal of active treatment
  • Allergic reactions to traditional Chinese medicine
  • Chemotherapy, radiotherapy, or high-dose immunosuppressant treatment within the last month
  • Participation in another clinical trial within the past 30 days
  • Pregnant or breastfeeding women
  • Severe gastrointestinal bleeding, intestinal obstruction, or increased intra-abdominal pressure of 20 mmHg or more

AI-Screening

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Trial Site Locations

Total: 1 location

1

First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China, 310006

Actively Recruiting

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Research Team

W

Wu JianNong, doctor

CONTACT

M

Meng-Yuan Shen, doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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