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

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Sepsis

In brief

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.

Key facts

Study ID: NCT06514339
Run by: The First Affiliated Hospital of Zhejiang Chinese Medical University
People needed: 410
Starts: 2024-07-01
Expected to finish: 2026-07-01
Last updated by the study team: 2025-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥18 years old
Meet the diagnostic criteria of sepsis 3.0 guidelines
Sign informed consent.

You may not qualify if…

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
Participants in other clinical trials at the same time or within 30 days
Pregnant and lactating women
Patients with severe gastrointestinal bleeding, intestinal obstruction, or severe intraperitoneal pressure elevation (IAP≥20mmHg).

Where it is running

First Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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