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

NCT06514339 | Recruiting Early Phase 1

• 1 other identifier: 2024-KLS-234-02
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Keywords

Sepsis; Shenhuang granules; Evidence-based evaluation; Effect mechanism research

Outcome Measures

Primary Outcomes (1)

• 28-day mortality rate

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

  28-day

Secondary Outcomes (6)

• Total length of stay and ICU stay

  7 day after treatment，14 day after treatment，28 day after treatment

• Total hospitalization costs and ICU hospitalization costs

  7 day after treatment，14 day after treatment，28 day after treatment

• Overall mortality and ICU mortality

  7 day after treatment，14 day after treatment，28 day after treatment

• 28 days cumulative no mechanical ventilation time

  28 day after treatment

• SOFA score

  day 0，day 5-7

Other Outcomes (12)

• Blood routine test

  day 0，7 day after treatment

• C-reactive protein

  day 0，7 day after treatment

• Procalcitonin

  day 0，7 day after treatment

Study Arms (2)

Treatment group

EXPERIMENTAL

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).

Drug: shenhuang granule

Control group

SHAM COMPARATOR

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).

Drug: placebo

Interventions

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.

Also known as: Tianjin Hongri Pharmaceutical Co., LTD

Treatment group

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.

Also known as: Tianjin Hongri Pharmaceutical Co., LTD

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead
• Zhejiang University: collaborator
• Red Cross Hospital, Hangzhou, China: collaborator
• Ningbo Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310006, China

RECRUITING

Related Publications (1)

• Shen MY, Li ZJ, Feng DD, Yang DD, Liu S, Fu YH, Fang BJ, Wu JN. Shenhuang Granules for patients with sepsis: study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial. Front Med (Lausanne). 2025 Nov 21;12:1700749. doi: 10.3389/fmed.2025.1700749. eCollection 2025.

  PMID: 41357500 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Wu JianNong, doctor

  The First Affiliated Hospital of Zhejiang Chinese Medical University

  STUDY CHAIR

• Liu Shan, doctor

  The First Affiliated Hospital of Zhejiang Chinese Medical University

  STUDY DIRECTOR

• Feng DanDan, master

  The First Affiliated Hospital of Zhejiang Chinese Medical University

  STUDY DIRECTOR

Central Study Contacts

Wu JianNong, doctor

CONTACT

13777571598; 13777571598@163.com

Meng-Yuan Shen, doctor

CONTACT

18261812250; 1355759459@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will adopt the block randomization method to randomly assign qualified subjects to the test group or the control group in a ratio of 1:1. A central randomization system was used for randomization and drug distribution management. From randomization until the database is locked, subjects, investigators, data analysts, sponsors, and all medical personnel involved in the treatment or clinical evaluation will remain blind to the reality of the treatment. The random number table (blind bottom) used in this study will be generated by the randomization specialist and imported into the system. The random number is reproducible. The relationship between the experimental group drug or the control group simulated drug and the subjects was represented by random number and drug number. The blind bottom is kept by the randomisation Specialist and remains unknown to both subjects and investigators throughout the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The researchers were randomly assigned to either a trial or a control group. Experimental group: sepsis cluster therapy + Shenhuang granules, course of 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). 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).

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 23, 2024
• Study Start: July 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)