Patients With Irritable Bowel Syndrome With DiarrheaPhase 2NCT07721012
Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
A Phase 2 study testing Huanghou Zhixie Diwan group and Huanghou Zhixie Diwan mimic in people with Patients With Irritable Bowel Syndrome With Diarrhea, run by Lei Yunshang Group at 14 sites in China.
Trial summary
This trial is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase II clinical trial. Its purpose is to evaluate the efficacy and safety of Huanghou Zhixie Diwan in subjects with irritable bowel syndrome with diarrhea (Large Intestinal Damp-heat syndrome) after 4 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patients With Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- Huanghou Zhixie Diwan group and Huanghou Zhixie Diwan mimic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 14 sitesChina
- Study dates
- 31 Jul 2026to 31 Aug 2027
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 65 years old, regardless of gender.
- Meeting the Western medicine diagnostic criteria for IBS-D (Rome IV criteria).
- Conforming to the TCM syndrome differentiation criteria for Large Intestinal Damp-heat.
- During the run-in period, the weekly average score of abdominal pain is ≥ 3 points based on the 11-point (0-10) Numerical Rating Scale (NRS); and there are at least 2 days per week with stool consistency classified as Type 6 or Type 7 according to the Bristol Stool Scale.
- The total score of the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) at baseline is ≥ 175 points.
- Colonoscopy performed within 12 months prior to the run-in period, and meeting one of the following conditions for enrollment:
- 1) Normal colonoscopy results with no organic lesions; 2) Abnormal colonoscopy findings such as hemorrhoids and intestinal polyps (diameter ≤ 5 mm, number ≤ 3), and assessed eligible for enrollment by the investigator; 3) Previous intestinal polyps with diameter > 5 mm or number > 3, which were treated endoscopically more than 6 months ago, with residual polyps of diameter ≤ 5 mm and number ≤ 3, and assessed eligible for enrollment by the investigator.
- Participants are fully conscious, free from mental illness or cognitive impairment, capable of understanding and completing scale assessments. All participants voluntarily agree to participate in this clinical trial, sign the informed consent form, and comply with all study protocol requirements throughout the trial.
Who cannot join
- Patients diagnosed with irritable bowel syndrome classified as IBS-C, IBS-M or IBS-U.
- Patients with a confirmed diagnosis of digestive system diseases in medical history or at screening, including peptic ulcer (excluding those with healed ulcers assessed by the investigator to have no impact on efficacy and safety evaluation), inflammatory bowel disease, intestinal tuberculosis, intestinal obstruction, intestinal adhesion, eosinophilic gastroenteritis, tuberculous peritonitis, liver cirrhosis, etc.
- Patients with acute diarrhea and/or severe abdominal pain caused by other diseases within 1 month prior to screening, or those suffering from other diseases assessed by the investigator to interfere with efficacy evaluation and increase safety risks.
- Patients with a history of abdominal surgery who may present symptoms similar to IBS as judged by the investigator (appendectomy and cesarean section are excluded).
- Patients with a confirmed diagnosis of systemic diseases affecting gastrointestinal function in medical history or at screening, such as diabetes mellitus, hyperthyroidism or hypothyroidism, chronic renal insufficiency, autoimmune diseases (e.g. allergic enteritis, Henoch-Schönlein purpura, Behçet's syndrome, systemic lupus erythematosus), etc.
- Patients complicated with other painful conditions such as arthritis and migraine that may interfere with Numeric Rating Scale (NRS) pain assessment; female patients with severe dysmenorrhea requiring analgesic medication.
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- Patients with malignant tumors within the past 5 years or diagnosed at screening.
- Participants presenting gastrointestinal alarm symptoms within 14 days prior to screening, including hematochezia, positive fecal occult blood test, anemia, ascites, nocturnal diarrhea, unexplained weight loss or fever, etc., who are deemed ineligible for enrollment by the investigator.
- Patients with severe diseases involving cardiovascular, cerebrovascular, hepatic, renal or other systems.
- Patients who have undergone surgical operation within 30 days prior to screening, which is assessed by the investigator to affect safety or efficacy evaluation, or those scheduled to receive surgery during the study period.
- Participants who have received medications or treatments for IBS within 4 weeks prior to randomization (e.g. antispasmodics, antidiarrheals, prokinetic agents, neurotransmitter regulators, intestinal flora modulators, traditional Chinese medicine, acupuncture and tuina).
- Participants who have taken other drugs affecting gastrointestinal function within 4 weeks prior to randomization (e.g. anticholinergics, 5-Hydroxytryptamine 3 (5-HT3) receptor antagonists, antacids, antidepressants, anxiolytics, opioid receptor agonists, long-term or high-dose non-steroidal anti-inflammatory drugs, traditional Chinese herbal decoctions, etc.), or those who cannot discontinue such drugs during the trial.
- Participants with abnormal liver and renal function test results at screening and baseline:
- Aspartate aminotransferase (AST) ≥ 1.5 times the Upper Limit of Normal (ULN);
- Alanine aminotransferase (ALT) ≥ 1.5 × ULN;
- Blood urea nitrogen (BUN) ≥ 1.5 × ULN; d) Serum creatinine > ULN.
- Participants with treatment compliance < 80% or > 120% during the run-in period, or those who completed the run-in period diary cards for fewer than 5 days per week.
- Participants who took rescue medication (pinaverium bromide) continuously or intermittently for more than 2 days in the first week of the run-in period (Day -14 to Day -8), or used the rescue medication (pinaverium bromide) in the second week of the run-in period (Day -7 to Day -1).
- Participants with a score ≥ 60 on the Self-Rating Anxiety Scale (SAS) and/or a score ≥ 63 on the Self-Rating Depression Scale (SDS) at screening.
- Participants with allergic diathesis or known allergy to the study drugs.
- Participants with a history of alcohol abuse or drug abuse within the past 1 year.
- Pregnant or lactating women; participants or their partners who plan to become pregnant during the period from signing the informed consent form to the end of follow-up, or refuse to adopt reliable non-drug contraceptive measures.
- Participants who have enrolled in and received treatment in any other clinical trial within the past 3 months.
- Other participants deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites
Beijing Traditional Chinese Medicine Hospital, Capital Medical University
Beijing
The First Hospital of Hunan University of Chinese Medicine
Changsha
Daqing People's Hospital
Daqing
GuangDong Second Traditional Chinese Medicine Hospital
Guangzhou
Inner Mongolia Hospital of Traditional Chinese Medicine
Hohhot
Lianyungang Hospital of Traditional Chinese Medicine
Lianyungang
Luoyang First People's Hospital
Luoyang
Luoyang Third People's Hospital
Luoyang
Meihekou Central Hospital
Meihekou
The Third Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin
Wenzhou TCM Hospital of Zhejiang Chinese Medical University
Wenzhou
Xiamen Hospital of Traditional Chinese Medicine
Xiamen
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Exploratory Clinical Study on the Efficacy and Safety of Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (Large Intestinal Damp-heat)
This trial is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase II clinical trial. Its purpose is to evaluate the efficacy and safety of Huanghou Zhixie Diwan in subjects with irritable bowel syndrome with diarrhea (Large Intestinal Damp-heat syndrome) after 4 weeks of treatment.
- Being tested
- Huanghou Zhixie Diwan group, Huanghou Zhixie Diwan mimic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huanghou Zhixie Diwan groupDrug
The prescription consists of Magnolia Officinalis extract, Coptis Chinensis extract, Zingiber Officinale oil, and Costus Root oil
Huanghou Zhixie Diwan mimicDrug
Placebo with "no pharmaceutically active ingredients", identical to the Huanghou Zhixie Diwan in color, odor and appearance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Huanghou Zhixie Diwan | Experimental | Huanghou Zhixie Diwan, 12 pills each time, 2 times a day, orally Receives: Drug: Huanghou Zhixie Diwan group |
| Control: Huanghou Zhixie Diwan mimic | Placebo comparator | Huanghou Zhixie Diwan mimic, 12 pills per dose, 2 times a day, orally Receives: Drug: Huanghou Zhixie Diwan mimic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective rate of IBS-D (weekly response)
Proportion of subjects who met the following criteria for at least 50% of the period from randomization to the end of 4-week of treatment:
- patients with a reduction of at least 30% from baseline in the weekly average of the most severe abdominal pain scores over the past 24 hours
- patients with a reduction of at least 50% from baseline in the number of days per week with at least one stool that has a consistency of Type 6 or 7 Bristol Stool Score compared with baseline
Measured: After 4-week treatment
Secondary outcomes (9)
Effective rate of IBS-D (daily response)
Proportion of subjects who met the following criteria for at least 50% of the period from randomization to the end of 4-week of treatment:
- patients with a reduction of at least 30% from baseline in the most severe abdominal pain scores over the past 24 hours
- patients whose stool type for each bowel movement is less Type 5 on the Bristol Stool Scale, or there is no bowel movement per day
Measured: After 4-week treatment
The changes in the frequency of stool Type 6 or 7 compared to baseline
Assess the changes in frequency of stool Type 6 or 7
Measured: Second and forth week of treatment
The changes in the days of stool Type 6 or 7 compared to baseline
Assess the changes in days of stool Type 6 or 7
Measured: Second and forth week of treatment
The changes in weekly average abdominal pain score compared to baseline using Numeric Rating Scale (Eleven-point scale, score range: 0-10, Lower-is-Better endpoint)
Assess the changes in weekly average abdominal pain score
Measured: Second and forth week of treatment, 4 weeks after discontinuing medication, 8 weeks after discontinuing medication
The changes in the frequency of abdominal pain compared to baseline
Assess the changes in the frequency of abdominal pain
Measured: Second and forth week of treatment, 4 weeks after discontinuing medication, 8 weeks after discontinuing medication
The changes in weekly average Urgency Numeric Rating Scale (Urgency NRS, Eleven-point scale, score range: 0-10, Lower-is-Better endpoint) compared to baseline
Assess the changes in weekly average Urgency NRS
Measured: Second and forth week of treatment, 4 weeks after discontinuing medication, 8 weeks after discontinuing medication
The changes in IBS Symptom Severity Score (IBS-SSS, score range: 0-500, Lower-is-Better endpoint) score compared to baseline
Assess the changes in IBS-SSS score compared to baseline
Measured: After 4-week treatment, 4 weeks after discontinuing medication, 8 weeks after discontinuing medication
Evaluation of Traditional Chinese Medicine Syndrome Efficacy
Assess the changes in Traditional Chinese Medicine (TCM) Syndrome score using a scale to be evaluated by a traditional Chinese medicine practitioner based on the patient's symptoms. The scale includes 2 primary symptoms and 4 secondary symptoms, and the assessment covers abdominal pain, diarrhea, bowel habits, and other related symptoms. The scale's score ranges is 0-24 and lower scores mean a better outcome. A reduction from baseline of ≥30% in the Traditional Chinese Medicine (TCM) Syndrome score is considered clinically effective, while a reduction of <30% is considered clinically ineffective.
Measured: After 2-week, 4-week treatment, 4 weeks after discontinuing medication, 8 weeks after discontinuing medication
The changes in Patient-Reported Outcome Instrument for Chronic Gastrointestinal Diseases (Thirty-five-item scale, score range: 0-139, Lower-is-Better endpoint) compared to baseline
Assess the changes in Patient-Reported Outcome Instrument for Chronic Gastrointestinal Diseases
Measured: After 4-week treatment, 4 weeks after discontinuing medication, 8 weeks after discontinuing medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Irritable Bowel Syndrome With DiarrheaStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Yunshang Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721012
- Sponsor's protocol ID
- HHZXDW-2025-01
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Exploratory Clinical Study on the Efficacy and Safety of Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (Large Intestinal Damp-heat)
- ClinicalTrials.gov ID
- NCT07721012
- Acronym / sponsor ID
- HHZXDW-2025-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lei Yunshang GroupIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 22 Jul 2026 (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.
This trial is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase II clinical trial. Its purpose is to evaluate the efficacy and safety of Huanghou Zhixie Diwan in subjects with irritable bowel syndrome with diarrhea (Large Intestinal Damp-heat syndrome) after 4 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Huanghou Zhixie Diwan | Experimental | Drug: Huanghou Zhixie Diwan groupHuanghou Zhixie Diwan, 12 pills each time, 2 times a day, orally |
| Control: Huanghou Zhixie Diwan mimic | Placebo comparator | Drug: Huanghou Zhixie Diwan mimicHuanghou Zhixie Diwan mimic, 12 pills per dose, 2 times a day, orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged from 18 to 65 years old, regardless of gender.
- Meeting the Western medicine diagnostic criteria for IBS-D (Rome IV criteria).
- Conforming to the TCM syndrome differentiation criteria for Large Intestinal Damp-heat.
- During the run-in period, the weekly average score of abdominal pain is ≥ 3 points based on the 11-point (0-10) Numerical Rating Scale (NRS); and there are at least 2 days per week with stool consistency classified as Type 6 or Type 7 according to the Bristol Stool Scale.
- The total score of the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) at baseline is ≥ 175 points.
Key exclusion criteria (24 listed)
- Patients diagnosed with irritable bowel syndrome classified as IBS-C, IBS-M or IBS-U.
- Patients with a confirmed diagnosis of digestive system diseases in medical history or at screening, including peptic ulcer (excluding those with healed ulcers assessed by the investigator to have no impact on efficacy and safety evaluation), inflammatory bowel disease, intestinal tuberculosis, intestinal obstruction, intestinal adhesion, eosinophilic gastroenteritis, tuberculous peritonitis, liver cirrhosis, etc.
- Patients with acute diarrhea and/or severe abdominal pain caused by other diseases within 1 month prior to screening, or those suffering from other diseases assessed by the investigator to interfere with efficacy evaluation and increase safety risks.
- Patients with a history of abdominal surgery who may present symptoms similar to IBS as judged by the investigator (appendectomy and cesarean section are excluded).
- Patients with a confirmed diagnosis of systemic diseases affecting gastrointestinal function in medical history or at screening, such as diabetes mellitus, hyperthyroidism or hypothyroidism, chronic renal insufficiency, autoimmune diseases (e.g. allergic enteritis, Henoch-Schönlein purpura, Behçet's syndrome, systemic lupus erythematosus), etc.
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 |
|---|---|---|
| Huanghou Zhixie Diwan groupThe prescription consists of Magnolia Officinalis extract, Coptis Chinensis extract, Zingiber Officinale oil, and Costus Root oil | Drug | Experimental: Huanghou Zhixie Diwan |
| Huanghou Zhixie Diwan mimicPlacebo with "no pharmaceutically active ingredients", identical to the Huanghou Zhixie Diwan in color, odor and appearance. | Drug | Control: Huanghou Zhixie Diwan mimic |
Primary outcome
Effective rate of IBS-D (weekly response)
Time frame: After 4-week treatment
Proportion of subjects who met the following criteria for at least 50% of the period from randomization to the end of 4-week of treatment: 1. patients with a reduction of at least 30% from baseline in the weekly average of the most severe abdominal pain scores over the past 24 hours 2. patients with a reduction of at least 50% from baseline in the number of days per week with at least one stool that has a consistency of Type 6 or 7 Bristol Stool Score compared with baseline
9 secondary outcomes
Effective rate of IBS-D (daily response)
Time frame: After 4-week treatment
The changes in the frequency of stool Type 6 or 7 compared to baseline
Time frame: Second and forth week of treatment
The changes in the days of stool Type 6 or 7 compared to baseline
Time frame: Second and forth week of treatment
The changes in weekly average abdominal pain score compared to baseline using Numeric Rating Scale (Eleven-point scale, score range: 0-10, Lower-is-Better endpoint)
Time frame: Second and forth week of treatment, 4 weeks after discontinuing medication, 8 weeks after discontinuing medication
The changes in the frequency of abdominal pain compared to baseline
Time frame: Second and forth week of treatment, 4 weeks after discontinuing medication, 8 weeks after discontinuing medication
The changes in weekly average Urgency Numeric Rating Scale (Urgency NRS, Eleven-point scale, score range: 0-10, Lower-is-Better endpoint) compared to baseline
Time frame: Second and forth week of treatment, 4 weeks after discontinuing medication, 8 weeks after discontinuing medication
The changes in IBS Symptom Severity Score (IBS-SSS, score range: 0-500, Lower-is-Better endpoint) score compared to baseline
Time frame: After 4-week treatment, 4 weeks after discontinuing medication, 8 weeks after discontinuing medication
Evaluation of Traditional Chinese Medicine Syndrome Efficacy
Time frame: After 2-week, 4-week treatment, 4 weeks after discontinuing medication, 8 weeks after discontinuing medication
The changes in Patient-Reported Outcome Instrument for Chronic Gastrointestinal Diseases (Thirty-five-item scale, score range: 0-139, Lower-is-Better endpoint) compared to baseline
Time frame: After 4-week treatment, 4 weeks after discontinuing medication, 8 weeks after discontinuing medication
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 Jul 2026.
- 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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Huanghou Zhixie Diwan group and Huanghou Zhixie Diwan mimic in people with Patients With Irritable Bowel Syndrome With Diarrhea, run by Lei Yunshang Group at 14 sites 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 8 inclusion and 24 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 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yayun Zhang (+86-18251834682, zhangyayun@lys.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective rate of IBS-D (weekly response) (time frame: After 4-week treatment). 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 22 Jul 2026.