Evidence-based Evaluation and Mechanism of Shenhuang Granules in the Treatment of Sepsis: a Randomized, Double-blind, Placebo-controlled, Effective Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years old

• Meet the diagnostic criteria of sepsis 3.0 guidelines

• Sign informed consent.

Locations
Other Locations
China
First Affiliated Hospital of Zhejiang Chinese Medical University
RECRUITING
Hangzhou
Contact Information
Primary
Wu JianNong, doctor
13777571598@163.com
13777571598
Backup
Meng-Yuan Shen, doctor
1355759459@qq.com
18261812250
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 410
Treatments
Experimental: Treatment group
Sepsis cluster therapy + Shenhuang granules for 5 days. For the treatment of sepsis cluster, refer to the 2021 International Guidelines for Severe Sepsis and Septic Shock. Shenhuang Granules (Tianjin Hongri Pharmaceutical Co., LTD.) : 2 times a day, 1 pack each time, 100ml of warm water (temperature about 40°C) after dissolution, oral or nasal feeding (stomach tube or intestinal tube).
Sham_comparator: Control group
Sepsis cluster therapy + placebo for 5 days. For the treatment of sepsis cluster, refer to the 2021 International Guidelines for Severe Sepsis and Septic Shock. Placebo (Tianjin Hongri Pharmaceutical Co., LTD.) : After dissolution of 100ml warm water (temperature about 40°C) in 1 pack twice a day, oral or nasal feeding (gastric tube or intestinal tube).
Related Therapeutic Areas
Sponsors
Collaborators: Zhejiang University, Red Cross Hospital, Hangzhou, China, Ningbo Hospital of Traditional Chinese Medicine
Leads: The First Affiliated Hospital of Zhejiang Chinese Medical University

This content was sourced from clinicaltrials.gov