SepsisEarly Phase 1NCT06514339
Evidence-based Evaluation and Mechanism of Shenhuang Granules in the Treatment of Sepsis
A Early Phase 1 study testing shenhuang granule in people with Sepsis, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- shenhuang granule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Jul 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- Meet the diagnostic criteria of sepsis 3.0 guidelines
- Sign informed consent.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006
Wu JianNong, doctor, 13777571598, 13777571598@163.com
About this study
Official title: Evidence-based Evaluation and Mechanism of Shenhuang Granules in the Treatment of Sepsis: a Randomized, Double-blind, Placebo-controlled, Effective Clinical 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.
Read the detailed description
- Baseline data: patient's name, gender, age, enrollment diagnosis, sepsis diagnosis time, combined underlying disease, allergy history, personal history, body temperature, respiration, heart rate, blood pressure, blood oxygen saturation and other vital signs.
- Primary outcome measure: 28-day mortality
- Secondary outcome indicators:
- Total length of stay and ICU stay B. Total hospitalization costs and ICU hospitalization costs C. Overall mortality and ICU mortality D.28 days cumulative no mechanical ventilation time E. Information of TCM syndrome such as tongue and pulse on day 0 and day 5-7 F. TCM symptom scores on days 0 and 5-7 G. SOFA score and APACHE II score on days 0 and 5-7.
- Other observation indicators (day 0 and 7) :
- Inflammatory markers: WBC, percentage of neutrophils, CRP, PCT, tumor necrosis factor (TNF-α), interleukin-6 (IL-6), interleukin-10 (IL-10); B. Main organ function indicators: BNP, TnI, creatinine, urea nitrogen, total bilirubin, direct bilirubin, indirect bilirubin, AST, ALT, arterial lactic acid; C. Coagulation indicators: PT, APTT; D. Immune function: absolute number of lymphocytes, number of CD4+T cells, number of CD8+T cells, number of B cells, number of NK cells.
- Safety indicators: adverse reaction symptoms or adverse events (such as allergies). If you need to collect stool and blood samples, you also need to observe the following indicators, if not, please ignore.
- Metabolomic study: Serum samples from day 0 and day 5-7 were collected for the study of the main functional components of Shenhuang granules and metabolomic analysis;
- Intestinal microecology study: Stool samples from day 0 and day 5-7 were collected for intestinal microecology study.
- Conditions
- Sepsis
- Being tested
- shenhuang granule, placebo
- Keywords
- Sepsis, Shenhuang granules, Evidence-based evaluation, Effect mechanism research
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shenhuang granuleDrug
Also called Tianjin Hongri Pharmaceutical Co., LTD
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.
placeboDrug
Also called Tianjin Hongri Pharmaceutical Co., LTD
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality rate
The proportion of deaths due to illness within 28 days after treatment began
Measured: 28-day
Secondary outcomes (6)
Total length of stay and ICU stay
Total length of stay and length of stay in ICU
Measured: 7 day after treatment，14 day after treatment，28 day after treatment
Total hospitalization costs and ICU hospitalization costs
The patient's total hospitalization costs and hospitalization costs in the ICU
Measured: 7 day after treatment，14 day after treatment，28 day after treatment
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
Measured: 7 day after treatment，14 day after treatment，28 day after treatment
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.
Measured: 28 day after treatment
SOFA score
The SOFA score uses six criteria to reflect the function of organ systems (respiratory, blood, liver, cardiovascular, nervous, and kidney) and sets each on a score of 0-4. The objective was to describe the occurrence, development and incidence of MODS
Measured: day 0，day 5-7
APACHE II score
The APACHE II score is based on 12 physiological indicators, age, and health status on a scale of 0-71. The higher the score, the more severe the reaction condition, the worse the prognosis, and the higher the expected fatality rate
Measured: day 0，day 5-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jul 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University, Red Cross Hospital, Hangzhou, China, Ningbo Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Wu JianNong, doctor, Study chair, The First Affiliated Hospital of Zhejiang Chinese Medical UniversityLiu Shan, doctor, Study director, The First Affiliated Hospital of Zhejiang Chinese Medical UniversityFeng DanDan, master, Study director, The First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514339
- Sponsor's protocol ID
- 2024-KLS-234-02
- Status last verified
- Aug 2025
- First submitted
- 19 Jun 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41357500
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-based Evaluation and Mechanism of Shenhuang Granules in the Treatment of Sepsis: a Randomized, Double-blind, Placebo-controlled, Effective Clinical Trial
- ClinicalTrials.gov ID
- NCT06514339
- Acronym / sponsor ID
- 2024-KLS-234-02
- Conditions
- Sepsis
- Keywords
- Sepsis, Shenhuang granules, Evidence-based evaluation, Effect mechanism research
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Collaborators
- Zhejiang University, Red Cross Hospital, Hangzhou, China, Ningbo Hospital of Traditional Chinese Medicine
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Baseline data: patient's name, gender, age, enrollment diagnosis, sepsis diagnosis time, combined underlying disease, allergy history, personal history, body temperature, respiration, heart rate, blood pressure, blood oxygen saturation and other vital signs.
- Primary outcome measure: 28-day mortality
- Secondary outcome indicators:
- Total length of stay and ICU stay B. Total hospitalization costs and ICU hospitalization costs C. Overall mortality and ICU mortality D.28 days cumulative no mechanical ventilation time E. Information of TCM syndrome such as tongue and pulse on day 0 and day 5-7 F. TCM symptom scores on days 0 and 5-7 G. SOFA score and APACHE II score on days 0 and 5-7.
- Other observation indicators (day 0 and 7) :
- Inflammatory markers: WBC, percentage of neutrophils, CRP, PCT, tumor necrosis factor (TNF-α), interleukin-6 (IL-6), interleukin-10 (IL-10); B. Main organ function indicators: BNP, TnI, creatinine, urea nitrogen, total bilirubin, direct bilirubin, indirect bilirubin, AST, ALT, arterial lactic acid; C. Coagulation indicators: PT, APTT; D. Immune function: absolute number of lymphocytes, number of CD4+T cells, number of CD8+T cells, number of B cells, number of NK cells.
- Safety indicators: adverse reaction symptoms or adverse events (such as allergies). If you need to collect stool and blood samples, you also need to observe the following indicators, if not, please ignore.
- Metabolomic study: Serum samples from day 0 and day 5-7 were collected for the study of the main functional components of Shenhuang granules and metabolomic analysis;
- Intestinal microecology study: Stool samples from day 0 and day 5-7 were collected for intestinal microecology study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: shenhuang granuleSepsis 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). |
| Control group | Sham comparator | Drug: placeboSepsis 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years old
- Meet the diagnostic criteria of sepsis 3.0 guidelines
- Sign informed consent.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shenhuang granuleAlso: Tianjin Hongri Pharmaceutical Co., LTDTraditional 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. | Drug | Treatment group |
| placeboAlso: Tianjin Hongri Pharmaceutical Co., LTDPlacebo 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. | Drug | Control group |
Primary outcome
28-day mortality rate
Time frame: 28-day
The proportion of deaths due to illness within 28 days after treatment began
6 secondary outcomes
Total length of stay and ICU stay
Time frame: 7 day after treatment，14 day after treatment，28 day after treatment
Total hospitalization costs and ICU hospitalization costs
Time frame: 7 day after treatment，14 day after treatment，28 day after treatment
Overall mortality and ICU mortality
Time frame: 7 day after treatment，14 day after treatment，28 day after treatment
28 days cumulative no mechanical ventilation time
Time frame: 28 day after treatment
SOFA score
Time frame: day 0，day 5-7
APACHE II score
Time frame: day 0，day 5-7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Derived from this study: PubMed 41357500Shen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wu JianNong, doctor study chair
The First Affiliated Hospital of Zhejiang Chinese Medical University
Liu Shan, doctor study director
The First Affiliated Hospital of Zhejiang Chinese Medical University
Feng DanDan, master study director
The First Affiliated Hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing shenhuang granule in people with Sepsis, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wu JianNong, doctor (13777571598, 13777571598@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality rate (time frame: 28-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06514339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.