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Phase III Clinical Trial of Changji'an Capsules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver-Qi Invading Spleen Syndrome)

22. května 2026 aktualizováno: Shengsheng Zhang, Beijing Hospital of Traditional Chinese Medicine

Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial on the Efficacy and Safety of Changji'an Capsules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver-Qi Invading Spleen Syndrome)

This trial is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase III clinical trial. Its purpose is to evaluate the efficacy and safety of Changji'an Capsules in subjects with diarrhea-predominant irritable bowel syndrome (liver-qi invading spleen syndrome) after 8 weeks of treatment.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

636

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
      • Chengdu, Čína
        • West China Hospital, Sichuan University
      • Chongqing, Čína
        • Chongqing Traditional Chinese Medicine Hospital
      • Guangzhou, Čína
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
      • Guizhou, Čína
        • The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
      • Haozhou, Čína
        • Haozhou People's Hospital
      • Hebei, Čína
        • Hebei Provincial Hospital of Traditional Chinese Medicine
      • Heilongjiang, Čína
        • The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
      • Hubei, Čína
        • Hubei Provincial Hospital of Traditional Chinese Medicine
      • Jinan, Čína
        • The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
      • Kaifeng, Čína
        • Kaifeng Hospital of Traditional Chinese Medicine
      • Luoyang, Čína
        • Luoyang First People's Hospital
      • Nanjing, Čína
        • Jiangsu Provincial Hospital of Traditional Chinese Medicine
      • Shanghai, Čína
        • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
      • Shanxi, Čína
        • The Affiliated Hospital of Shaanxi University of Chinese Medicine
      • Shaoyang, Čína
        • Shaoyang Central Hospital
      • Shiyan, Čína
        • Shiyan People's Hospital
      • Tianjin, Čína
        • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
      • Tianjin, Čína
        • The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
      • Wenzhou, Čína
        • Wenzhou Traditional Chinese Medicine Hospital
      • Wuhan, Čína
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Wuxi, Čína
        • Wuxi Traditional Chinese Medicine Hospital
      • Xi'an, Čína
        • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Čína
        • Xi'an Central Hospital
      • Xingtai, Čína
        • Xingtai People's Hospital
      • Yueyang, Čína
        • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
      • Zhejiang, Čína
        • Zhejiang Provincial Hospital of Traditional Chinese Medicine
      • Zhengzhou, Čína
        • Zhengzhou First People's Hospital
      • Zhujiang, Čína
        • Zhujiang Hospital, Southern Medical University
    • Dongcheng District
      • Beijing, Dongcheng District, Čína, 100010
        • Beijing Hospital of Traditional Chinese Medicine
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  1. Meet the Western medicine diagnostic criteria for diarrhea-predominant irritable bowel syndrome;
  2. Meet the Traditional Chinese Medicine syndrome differentiation criteria for liver Qi invading the spleen;
  3. Aged ≥18 and ≤65 years, regardless of gender;
  4. Record daily the most severe abdominal pain, bloating, and abdominal discomfort NRS scores for the last week of the run-in period. At least one of these three items must meet the weekly average NRS score criterion (the weekly average of abdominal pain NRS is calculated as: total weekly score of abdominal pain NRS on days with Bristol Stool Form Scale type 6 or 7 stools / actual number of days with Bristol type 6 or 7 stools in that week; the average values for the other two items are calculated similarly) ≥3 points (11-point Numerical Rating Scale, NRS-11); meanwhile, for stool form, during the last week of the run-in period, there must be at least 2 days in which each day has at least one bowel movement of Bristol type 6 or 7;
  5. Self-Rating Anxiety Scale (SAS) <60 points and Self-Rating Depression Scale (SDS) <63 points;
  6. Have a colonoscopy result showing no obvious abnormalities (including diverticula or chronic inflammation) or colon polyps, based on colonoscopy results within 12 months prior at a tertiary hospital: 1.Colonoscopy results are normal with no organic changes; 2. Colonoscopy report shows minor abnormalities such as hemorrhoids or colonic polyps (diameter ≤5mm and number ≤3), which the investigator deems eligible for inclusion; 3. Previous colonoscopy reported colonic polyps with diameter >5mm or number >3, but after endoscopic treatment within 6 months prior to screening, remaining polyps are ≤5mm in diameter and ≤3 in number, deemed eligible by the investigator;
  7. Agree to participate in this clinical trial and voluntarily sign the informed consent form.

Exclusion Criteria:

  1. Individuals with fewer than 3 spontaneous bowel movements per week during the induction period;
  2. Individuals with stool consistency of type 1 or 2 (Bristol Stool Form Scale) on at least 2 days per week during the induction period;
  3. Individuals confirmed to have infectious diarrhea, inflammatory bowel disease, parasitic infection, positive fecal occult blood tests and considered to have gastrointestinal bleeding (excluding hemorrhoids), colorectal tumors, malabsorption syndrome, lactose intolerance (based on medical history), and diarrhea caused by systemic diseases;
  4. Individuals who have used other medications for irritable bowel syndrome within 1 week prior to screening;
  5. Individuals with non-IBS-D or other organic gastrointestinal lesions (excluding superficial gastritis, grade I erosive gastritis, or chronic atrophic gastritis found on endoscopy but deemed by the investigator to be eligible for inclusion (e.g., no mucosal erosion or bleeding observed endoscopically, and the patient has no upper abdominal fullness, upper abdominal pain, or acid reflux)), or other organic lesions that the investigator judges may cause abdominal pain, bloating, or discomfort;
  6. Individuals with diabetes, hyperthyroidism, or serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, hematopoietic systems, or other serious diseases affecting survival (e.g., tumors), abnormal liver and kidney function (AST, ALT > 1.5 times the upper limit of normal reference range, Scr above the upper limit of normal reference range), and clinically significant ECG abnormalities;
  7. Individuals with other mental disorders (excluding mild anxiety or depression);
  8. Individuals with a history of gastrointestinal surgery (excluding appendectomy or intestinal polyp removal);
  9. Individuals who, within 2 weeks prior to screening, are using or need to continue using medications that may affect gastrointestinal function (anticholinergic drugs, 5-HT3 receptor antagonists, antidiarrheal drugs, antacids, prokinetic drugs, antidepressants (fluoxetine for at least 28 days), anti-anxiety drugs, intestinal microbiota regulators, traditional Chinese medicine decoctions, etc.);
  10. Individuals allergic to 3 or more medications or foods, or known allergies to Xiangjie Capsules and its components, as well as emergency medication Pivabromium tablets;
  11. Individuals who took emergency medication (Pivabromium tablets) during the last week of the induction period;
  12. Individuals who took prohibited medications during the induction period;
  13. Individuals suspected of or confirmed with a history of alcohol or drug abuse;
  14. Pregnant women, breastfeeding women, or women of childbearing age planning to conceive; or female participants of childbearing potential and male participants (whose partners are women of childbearing potential) who do not agree to voluntarily use effective contraception from screening to 3 months after the last dose;
  15. Individuals with cognitive impairment unable to provide fully informed consent;
  16. Individuals positive for hepatitis B surface antigen, HIV antibody, hepatitis C antibody, or syphilis treponemal antibody;
  17. Individuals who have participated in another clinical trial within the past month;
  18. Individuals known to have familial colorectal cancer syndrome;
  19. Individuals who, in the opinion of the investigator, have other factors making them unsuitable for inclusion.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Chang Ji'an capsule group
Chang Ji'an Capsules, 4 capsules each time, 3 times a day, orally
Lék: Chang Ji'an capsule
The prescription consists of 13 medicinal ingredients including Radix Paeoniae Alba, Rhizoma Atractylodis Macrocephalae (processed), and Radix Astragali.
Komparátor placeba: Placebo group
Chang Ji'an Capsules mimic, 4 capsules per dose, 3 times a day, orally
Lék: Chang Ji'an capsule mimic
Mock capsules with "no pharmaceutically active ingredients", identical to the Chang Ji'an capsule in color, odor and appearance.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Response rate of diarrhea (stool characteristics) at the end of 8 weeks of treatment
Časové okno: Evaluation will be performed at Day 56.
Proportion of subjects who met the following criteria for at least 50% of the period from randomization to the end of Week 8 of treatment: 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, and abdominal pain, abdominal distension and abdominal discomfort are unchanged or improved in comparison with baseline.
Evaluation will be performed at Day 56.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The abdominal pain response rate at the end of treatment weeks 2, 4, 6 and 8
Časové okno: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Proportion of subjects who satisfy the following criteria in no less than 50% of the treatment period from randomization to week endpoint: patients who experience a decrease in the weekly average of worst abdominal pain in the past 24 hours score of at least 30 percent compared with baseline, and the number of days per week with at least one stool with consistency of Type 6 or 7 that is the same as baseline or decreased and the number of stools of Type 6 or 7 on those days remains unchanged or decreased.
Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
The response rate of diarrhea (stool form) at the end of treatment weeks 2, 4 and 6
Časové okno: Evaluation will be performed at baseline and Day 14, Day 28, Day 42.
Proportion of subjects who met the following criteria for at least 50% of the period from randomization to week endpoint: 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, and abdominal pain, abdominal distension and abdominal discomfort are unchanged or improved in comparison with baseline.
Evaluation will be performed at baseline and Day 14, Day 28, Day 42.
Treatment response rate at the end of treatment weeks 2, 4, 6 and 8
Časové okno: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Defined as the proportion of subjects who meet the following criteria during at least 50% of the treatment period from randomization to the week endpoint: 1.Intensity of abdominal pain, abdominal distension and abdominal discomfort: a decrease in the weekly average of worst abdominal pain, abdominal distension and abdominal discomfort in the past 24 hours score of at least 30 percent compared with baseline; 2.Stool form: 50 percent or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Distention response rate at the end of treatment weeks 2, 4, 6 and 8
Časové okno: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Proportion of subjects who satisfy the following criteria in no less than 50% of the treatment period from randomization to week endpoint: patients who experience a decrease in the weekly average of worst abdominal distention in the past 24 hours score of at least 30 percent compared with baseline, and the number of days per week with at least one stool with consistency of Type 6 or 7 that is the same as baseline or decreased and the number of stools of Type 6 or 7 on those days remains unchanged or decreased.
Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Response rate of abdominal discomfort at the end of 2, 4, 6, and 8 weeks of treatment
Časové okno: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Proportion of subjects who satisfy the following criteria in no less than 50% of the treatment period from randomization to week endpoint: patients who experience a decrease in the weekly average of worst abdominal discomfort in the past 24 hours score of at least 30 percent compared with baseline, and the number of days per week with at least one stool with consistency of Type 6 or 7 that is the same as baseline or decreased and the number of stools of Type 6 or 7 on those days remains unchanged or decreased.
Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Changes in the number of days with diarrhea in the past week compared to baseline at the end of 2, 4, 6, and 8 weeks of treatment
Časové okno: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Among patients with unchanged or improved intensity of abdominal pain, abdominal distension and abdominal discomfort, the change from baseline in the number of days with Bristol Stool Form Scale type 6 or 7 at least once during the week.
Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Changes in the average number of diarrhea episodes in the past week compared to baseline at the end of 2, 4, 6, and 8 weeks of treatment
Časové okno: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Defined as the change from baseline in the weekly frequency of Bristol Stool Form Scale Type 6 or 7 stools divided by 7 days, among patients whose intensity of abdominal pain, abdominal distension, and abdominal discomfort remained unchanged or improved.
Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Changes in Urgency Numeric Rating Scale(Likert 5 point scale, score range:0-4, Lower-is-Better endpoint) compared to baseline at the end of weeks 2, 4, 6, and 8, and in the past 2 weeks
Časové okno: Evaluation will be performed at baseline and D14, D28, D42, D56.
Assessed based on the change in defecation urgency score.
Evaluation will be performed at baseline and D14, D28, D42, D56.
Changes from baseline in IBS Symptom Severity Score (IBS-SSS, score range:0-500, Lower-is-Better endpoint) at the end of 2, 4, 6, and 8 weeks of treatment.
Časové okno: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Assessed by the changes in scores of the IBS-SSS scales.
Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Changes from baseline in Quality of Life scale score (IBS-QOL, score range:0-136, Lower-is-Better endpoint) at the end of 2, 4, 6, and 8 weeks of treatment.
Časové okno: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Assessed by the changes in scores of the IBS-QOL scales.
Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Changes from baseline in Traditional Chinese Medicine syndrome score at the end of treatment weeks 2, 4, 6 and 8.
Časové okno: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Assessed by the changes in Traditional Chinese Medicine (TCM) syndrome scores.
Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Proportion of subjects with sustained remission and no worsening of diarrhea severity at Week 4 and Week 8 during the follow-up period.
Časové okno: Evaluations will be performed at baseline, 4 and 8 weeks of the follow-up period after the end of treatment.
Assessed via the Likert scale(Likert 7 point scale, score range:1-7, Lower-is-Better endpoint) completed in ePRO.
Evaluations will be performed at baseline, 4 and 8 weeks of the follow-up period after the end of treatment.
Proportion of subjects without diarrhea associated with diarrhea-predominant irritable bowel syndrome at follow-up Week 4 and Week 8.
Časové okno: Evaluations will be performed at Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56 after treatment completion.
Assessed via the Likert scale(Likert 7 point scale, score range:1-7, Lower-is-Better endpoint) completed in ePRO.
Evaluations will be performed at Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56 after treatment completion.
Usage of rescue medication
Časové okno: Evaluations shall be conducted at Week 8 of treatment.
Statistical analysis will be performed based on the consumption of rescue medication throughout the entire trial period.
Evaluations shall be conducted at Week 8 of treatment.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Beijing Hospital of Traditional Chinese Medicine

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

31. května 2026

Primární dokončení (Odhadovaný)

31. ledna 2028

Dokončení studie (Odhadovaný)

31. května 2028

Termíny zápisu do studia

První předloženo

17. května 2026

První předloženo, které splnilo kritéria kontroly kvality

22. května 2026

První zveřejněno (Aktuální)

28. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

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Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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