Perioperative PeriodEarly Phase 1NCT07066059
Study on the Efficacy and Safety of Shouhui Tongbian Capsules in Protecting Intestine During the Perioperative Period
A Early Phase 1 study testing Shouhui Tongbian Capsules in people with Perioperative Period, run by Shandong University at 1 site in China.
Trial summary
The goal of this clinical trial is to investigate if Shouhui Tongbian Capsules can shorten intestinal function recovery time (exhaust/defecation time) and improve defecation quality in perioperative patients, and to evaluate its safety and comfort advantages during the perioperative period. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Perioperative Period
- What is being tested?
- Shouhui Tongbian Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Jul 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years, regardless of gender;
- ASA class I-III, elective surgery patients;
- Signed the informed consent form.
Who cannot join
- Disease-related exclusions:
- Digestive system diseases: intestinal obstruction, intestinal perforation, acute peritonitis; inflammatory bowel disease (ulcerative colitis, Crohn's disease); gastrointestinal tumors (primary or metastatic); severe hemorrhoids or anal fissures (grade Ⅲ-Ⅳ); severe liver disease (Child-Pugh class ≥ B); Other systemic diseases: severe cardiovascular diseases (cardiac function grade Ⅲ or above, severe arrhythmia); uncontrolled diabetes (fasting blood glucose > 11.1 mmol/L); autoimmune diseases (such as active systemic lupus erythematosus, rheumatoid arthritis); advanced malignant tumors or during radiotherapy/chemotherapy.
- Liver and kidney function abnormalities:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN); serum creatinine (Cr) > 1.5 times ULN; estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m².
- Medication-related exclusions:
- Use of the following drugs within the past 2 weeks:
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- Laxatives (e.g., lactulose, polyethylene glycol), gastrointestinal motility agents (e.g., domperidone, mosapride), antibiotics (systemic use), opioid analgesics, anticholinergic drugs, long-term laxative use (continuous use ≥ 2 weeks), preoperative use of enteral nutrition preparations or intravenous nutritional support.
- Exclusions for special populations:
- Pregnant or lactating women; those allergic to components of Shouhui Tongbian Capsules (including Chinese herbal ingredients such as ginseng, atractylodes, polygonum multiflorum); patients with mental disorders or cognitive impairment; emergency or urgent surgery patients; those with an expected postoperative hospital stay < 3 days.
- Other exclusions:
- Participation in other clinical trials without passing the washout period; other situations where the investigator deems the subject unsuitable for the study.
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
Shandong Public Health Clinical Center
Jinan
Qiang Zhang, +8615562659602, zq-9999@163.com
About this study
The goal of this clinical trial is to investigate if Shouhui Tongbian Capsules can shorten intestinal function recovery time (exhaust/defecation time) and improve defecation quality in perioperative patients, and to evaluate its safety and comfort advantages during the perioperative period. The study involves participants aged 18-70 years, both male and female, with ASA grade I-III scheduled for elective surgery. The main questions it aims to answer are:
Can Shouhui Tongbian Capsules shorten the intestinal function recovery time (first flatus and defecation time) in perioperative patients? Can Shouhui Tongbian Capsules improve defecation quality (assessed by Bristol Stool Scale) and reduce inflammatory factor levels (e.g., IL-6, TNF-α)? Researchers will compare the experimental group (receiving Shouhui Tongbian Capsules 2 pills twice daily from admission to the night before surgery, then resuming after bowel sound recovery and oral intake postoperatively, with a 3-day post-discharge regimen) to the control group (receiving routine perioperative care including diet control and standard bowel-cleansing drugs) to see if the capsules show superior efficacy in intestinal function recovery and safety.
Read more
Participants will:
Take Shouhui Tongbian Capsules according to the specified regimen (experimental group) or receive routine care (control group).
Have their exhaust/defecation status recorded every 6 hours postoperatively. Undergo blood tests for liver/kidney function and inflammatory factors on the day before surgery and day 3 postoperatively.
Complete questionnaires on bowel preparation comfort and postoperative defecation satisfaction.
- Conditions
- Perioperative Period
- Being tested
- Shouhui Tongbian Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shouhui Tongbian CapsulesDrug
2 pills twice daily from admission to the night before surgery, then resuming after bowel sound recovery and oral intake postoperatively, with a 3-day post-discharge regimen
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment group | No intervention | Receive routine perioperative care including diet control and standard bowel-cleansing drugs |
| Shouhui Tongbian Capsules group | Experimental | Receive Shouhui Tongbian Capsules Receives: Drug: Shouhui Tongbian Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative intestinal function recovery time
Observe and record the postoperative intestinal function recovery time of the two groups of patients (including the time of first exhaust and defecation). The shorter the time, the better.
Measured: Throughout the study drug treatment period, about 2 weeks
Total duration of intestinal function recovery
Observe and record the total duration of intestinal function recovery of the two groups of patients. The shorter the time, the better.
Measured: Throughout the study drug treatment period, about 2 weeks
Defecation trait score
Observe and record the defecation trait score of the two groups of patients (using the Bristol Stool Scale). Seven types of stools based on shape and consistency, with type 1 being the hardest and type 7 being the softest
Measured: Throughout the study drug treatment period, about 2 weeks
Levels of inflammatory factors
Measure the levels of inflammatory factors (such as IL-6, TNF-α, etc.).
Measured: Throughout the study drug treatment period, about 2 weeks
Secondary outcomes (3)
Adverse event rate
Record adverse events occurring in the two groups of patients during the study period, including gastrointestinal discomfort (nausea, vomiting, abdominal pain, etc.), changes in liver and kidney function indicators, etc.
Measured: Throughout the study drug treatment period, about 2 weeks
Comfort of intestinal preparation satisfaction questionnaire
Evaluate the differences in comfort of intestinal preparation satisfaction between the two groups of patients through questionnaires. The higher the score, the better.
Measured: Throughout the study drug treatment period, about 2 weeks
Postoperative defecation satisfaction questionnaire
Evaluate the differences in postoperative defecation satisfaction between the two groups of patients through questionnaires. The higher the score, the better.
Measured: Throughout the study drug treatment period, about 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative PeriodStudies 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Public Health Clinical Center
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
- Investigators
- Qiang Zhang, Principal investigator, Shandong Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066059
- Sponsor's protocol ID
- SDU-2025-XM-002
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Shouhui Tongbian Capsules in Protecting Intestine During the Perioperative Period
- ClinicalTrials.gov ID
- NCT07066059
- Acronym / sponsor ID
- SDU-2025-XM-002
- Conditions
- Perioperative Period
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Public Health Clinical Center
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 15 Jul 2025 (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.
The goal of this clinical trial is to investigate if Shouhui Tongbian Capsules can shorten intestinal function recovery time (exhaust/defecation time) and improve defecation quality in perioperative patients, and to evaluate its safety and comfort advantages during the perioperative period. The study involves participants aged 18-70 years, both male and female, with ASA grade I-III scheduled for elective surgery. The main questions it aims to answer are:
Can Shouhui Tongbian Capsules shorten the intestinal function recovery time (first flatus and defecation time) in perioperative patients? Can Shouhui Tongbian Capsules improve defecation quality (assessed by Bristol Stool Scale) and reduce inflammatory factor levels (e.g., IL-6, TNF-α)? Researchers will compare the experimental group (receiving Shouhui Tongbian Capsules 2 pills twice daily from admission to the night before surgery, then resuming after bowel sound recovery and oral intake postoperatively, with a 3-day post-discharge regimen) to the control group (receiving routine perioperative care including diet control and standard bowel-cleansing drugs) to see if the capsules show superior efficacy in intestinal function recovery and safety.
Participants will:
Take Shouhui Tongbian Capsules according to the specified regimen (experimental group) or receive routine care (control group).
Have their exhaust/defecation status recorded every 6 hours postoperatively. Undergo blood tests for liver/kidney function and inflammatory factors on the day before surgery and day 3 postoperatively.
Complete questionnaires on bowel preparation comfort and postoperative defecation satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment group | No intervention | –Receive routine perioperative care including diet control and standard bowel-cleansing drugs |
| Shouhui Tongbian Capsules group | Experimental | Drug: Shouhui Tongbian CapsulesReceive Shouhui Tongbian Capsules |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-70 years, regardless of gender;
- ASA class I-III, elective surgery patients;
- Signed the informed consent form.
Key exclusion criteria (11 listed)
- Disease-related exclusions:
- Digestive system diseases: intestinal obstruction, intestinal perforation, acute peritonitis; inflammatory bowel disease (ulcerative colitis, Crohn's disease); gastrointestinal tumors (primary or metastatic); severe hemorrhoids or anal fissures (grade Ⅲ-Ⅳ); severe liver disease (Child-Pugh class ≥ B); Other systemic diseases: severe cardiovascular diseases (cardiac function grade Ⅲ or above, severe arrhythmia); uncontrolled diabetes (fasting blood glucose > 11.1 mmol/L); autoimmune diseases (such as active systemic lupus erythematosus, rheumatoid arthritis); advanced malignant tumors or during radiotherapy/chemotherapy.
- Liver and kidney function abnormalities:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN); serum creatinine (Cr) > 1.5 times ULN; estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m².
- Medication-related exclusions:
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 |
|---|---|---|
| Shouhui Tongbian Capsules2 pills twice daily from admission to the night before surgery, then resuming after bowel sound recovery and oral intake postoperatively, with a 3-day post-discharge regimen | Drug | Shouhui Tongbian Capsules group |
Primary outcome
Postoperative intestinal function recovery time
Time frame: Throughout the study drug treatment period, about 2 weeks
Observe and record the postoperative intestinal function recovery time of the two groups of patients (including the time of first exhaust and defecation). The shorter the time, the better.
Total duration of intestinal function recovery
Time frame: Throughout the study drug treatment period, about 2 weeks
Observe and record the total duration of intestinal function recovery of the two groups of patients. The shorter the time, the better.
Defecation trait score
Time frame: Throughout the study drug treatment period, about 2 weeks
Observe and record the defecation trait score of the two groups of patients (using the Bristol Stool Scale). Seven types of stools based on shape and consistency, with type 1 being the hardest and type 7 being the softest
Levels of inflammatory factors
Time frame: Throughout the study drug treatment period, about 2 weeks
Measure the levels of inflammatory factors (such as IL-6, TNF-α, etc.).
3 secondary outcomes
Adverse event rate
Time frame: Throughout the study drug treatment period, about 2 weeks
Comfort of intestinal preparation satisfaction questionnaire
Time frame: Throughout the study drug treatment period, about 2 weeks
Postoperative defecation satisfaction questionnaire
Time frame: Throughout the study drug treatment period, about 2 weeks
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 15 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Qiang Zhang principal investigator
Shandong Public Health Clinical Center
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 Shouhui Tongbian Capsules in people with Perioperative Period, run by Shandong 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 11 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: opening soon, as of the sponsor's last update on 15 Jul 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. 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 Wei Zhao, Ph.D (86053188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative intestinal function recovery time (time frame: Throughout the study drug treatment period, about 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2025.