Research on the Efficacy and Mechanism of Shouhui Tongbian Capsules in Treating Postoperative Constipation of Benign Anal and Rectal Diseases Based on Gut Microbiota Analysis
The goal of this clinical trial is to evaluate whether Shouhui Tongbian Capsule can improve postoperative constipation in adults aged 18 to 75 years after surgery for benign anorectal diseases, including hemorrhoids and anal fistula. The clinical trial will also evaluate the safety of Shouhui Tongbian Capsule and explore associations between treatment effects and changes in gut microbiota, metabolic profiles, and inflammatory indicators.
The main questions are:
Does Shouhui Tongbian Capsule improve constipation symptoms after benign anorectal surgery? Does Shouhui Tongbian Capsule reduce postoperative and defecation-related pain? Does Shouhui Tongbian Capsule improve quality of life and anorectal function? What adverse events occur during treatment? Are clinical improvements associated with changes in gut microbiota, metabolic profiles, or inflammatory indicators?
Researchers will compare Shouhui Tongbian Capsule with lactulose to evaluate differences in efficacy and safety for postoperative constipation.
Participants will:
Receive either Shouhui Tongbian Capsule three times daily or lactulose once daily for 14 days Complete assessments of constipation symptoms, pain, quality of life, and anorectal function Provide stool and blood samples before treatment and on Day 14 Attend assessments during treatment and approximately 1 month after surgery Report adverse events and other medical problems during participation
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lihua Zheng
- Numéro de téléphone: 13366566578
- E-mail: Zhenglihua0819@163.com
Lieux d'étude
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Chaoyang District
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Beijing, Chaoyang District, Chine, 100029
- China-Japan Friendship Hospital
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Contact:
- Lihua Zheng
- Numéro de téléphone: 13366566578
- E-mail: Zhenglihua0819@163.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
Surgical indication for a benign anorectal disease, including hemorrhoids or anal fistula Diagnosis of postoperative constipation after benign anorectal surgery Postoperative constipation symptoms such as difficulty defecating, reduced bowel movement frequency, hard or lumpy stools, incomplete evacuation, anorectal obstruction, or abdominal distension Ability to tolerate the planned anorectal surgical procedure without related contraindications Consciousness and ability to cooperate with treatment, follow-up, and questionnaire assessments Written informed consent provided by the participant or legally authorized representative Age 18 to 75 years, inclusive
Exclusion Criteria:
Severe systemic disease, including serious psychiatric or immune disorders Severe infection Malignant tumor Severe organic disease of a major organ, including the heart, liver, or kidneys Pregnancy Breastfeeding Postpartum period Coagulation dysfunction Other anorectal disease that may affect outcome assessment Known allergy to either study treatment or any treatment component Any other condition considered by the investigators to make participation unsuitable
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Shouhui Tongbian Capsules Treatment Group
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Participants assigned to the Shouhui Tongbian Capsule group will receive routine postoperative care together with oral Shouhui Tongbian Capsule for 14 consecutive days.
The dose will be two capsules per administration, three times daily, taken with warm water approximately 30 minutes after breakfast, lunch, and dinner.
Each capsule contains 0.35 g of the approved marketed product.
During the treatment period, other laxatives, probiotics, Chinese herbal medicines, or drugs that may affect intestinal motility or gut microbiota will generally be prohibited unless clinically necessary.
Medication use, treatment adherence, drug dispensing, returns, adverse events, and any rescue treatment will be recorded throughout the study.
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Comparateur actif: Lactulose Oral Solution Control Group
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Participants assigned to the lactulose group will receive routine postoperative care together with lactulose oral solution for 14 consecutive days.
Lactulose will be administered orally at a dose of 15 mL once daily in the morning.
Participants will receive both verbal and written instructions on the dose, administration method, and treatment schedule.
During the study, other laxatives, probiotics, Chinese herbal medicines, or medications that may affect intestinal motility or gut microbiota will generally be prohibited unless clinically necessary.
Treatment adherence, concomitant medications, adverse events, and any rescue treatment for severe constipation, pain, or postoperative discomfort will be recorded in the case report form.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Patient Assessment of Constipation-Symptoms Total Score From Baseline to Day 14
Délai: From baseline before treatment to the end of treatment on Day 14.
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The Patient Assessment of Constipation-Symptoms questionnaire is a 12-item participant-reported measure used to assess the severity of constipation symptoms.
The questionnaire includes four abdominal symptom items, three rectal symptom items, and five stool symptom items.
Each item is rated on a 5-point scale from 0 to 4, where 0 indicates "absent," 1 indicates "mild," 2 indicates "moderate," 3 indicates "severe," and 4 indicates "very severe."
The overall score is calculated as the mean of the completed item scores and ranges from 0 to 4. Higher scores indicate more severe constipation symptoms.
The questionnaire will be completed before treatment and on Day 14. Change from baseline will be calculated as the Day 14 score minus the baseline score; a larger negative change indicates greater improvement.
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From baseline before treatment to the end of treatment on Day 14.
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-KY-178-1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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