irritable bowel syndrome
Conditions
Interventions
group 1:participants receive TCKM granules together with information that they are given TCKM granules
group 2:participants receive TCKM granules together with information that they are given placebo granules
group 3:participants receive placebo granules together with information that they are given placebo granules
group 4:participants receive placebo granules together with information that they are given TCKM granules
Sponsors
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Diagnosis with diarrhea-predominant irritable bowel syndrome based on Rome IV diagnostic criteria (2) Aged between 18 and 65 years old of both sexes (3) Ongoing symptoms, defined as a reported IBS symptom severity score (IBS-SSS) of >=175 at screening
Exclusion criteria
Exclusion criteria: (1) Alarm symptoms, such as uninvestigated anemia, rectal bleeding, and significant weight loss (2) Other gastrointestinal diseases, such as inflammatory bowel disease, celiac disease and concurrent enteric infection (3) Diagnosed lactose intolerance (4) Having undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy or caesarean section (5) Reporting a score of > 50 on the Self-rating Anxiety Scale (SAS) or a score of > 53 on the Self-rating Depression Scale (SDS) (6) Concurrent serious diseases, such as malignancies, hyperthyroidism, serious cardiovascular, respiratory, hepatic, renal, neurological disease or psychiatric disorders (7) Unwilling or unable to stop taking medication which affects the assessment of interventions (8) Pregnancy, breastfeeding, or planning to conceive within 1 month (9) Currently or previously participating in another trial of an investigational medicinal product within the 3 months prior to screening (10) Patients who, in the opinion of the researcher, are unsuitable for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irritable Bowel Syndromes Symptom Severity Score (IBS-SSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Adequate relief (AR);Irritable Bowel Syndrome-Quality of Life Questionnaire (IBS-QOL);Hospital Anxiety and Depression Scale (HADS);Severity of abdominal pain;Severity of abdominal discomfort;Severity of abdominal distension;Stool frequency;Stool consistency;Feeling of incomplete evacuation;Urgency of defecation;Mucus stool; | — |
Countries
China
Contacts
Public ContactLi Qian
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed