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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
The prescription consists of Magnolia Officinalis extract, Coptis Chinensis extract, Zingiber Officinale oil, and Costus Root oil
Placebo with "no pharmaceutically active ingredients", identical to the Huanghou Zhixie Diwan in color, odor and appearance.
Beijing Traditional Chinese Medicine Hospital, Capital Medical University
Beijing, China
The First Hospital of Hunan University of Chinese Medicine
Changsha, China
Daqing People's Hospital
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: 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
Time frame: After 4-week treatment
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: 1. patients with a reduction of at least 30% from baseline in the most severe abdominal pain scores over the past 24 hours 2. 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
Time frame: 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
Time frame: 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
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)
Assess the changes in weekly average abdominal pain score
Time frame: Second and forth week of treatment, 4 weeks after discontinuing medication, 8 weeks after discontinuing medication
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Daqing, China
GuangDong Second Traditional Chinese Medicine Hospital
Guangzhou, China
Inner Mongolia Hospital of Traditional Chinese Medicine
Hohhot, China
Lianyungang Hospital of Traditional Chinese Medicine
Lianyungang, China
Luoyang First People's Hospital
Luoyang, China
Luoyang Third People's Hospital
Luoyang, China
Meihekou Central Hospital
Meihekou, China
The Third Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, China
...and 4 more locations
The changes in the frequency of abdominal pain compared to baseline
Assess the changes in the frequency of abdominal pain
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
Assess the changes in weekly average Urgency NRS
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
Assess the changes in IBS-SSS 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
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.
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
Assess the changes in Patient-Reported Outcome Instrument for Chronic Gastrointestinal Diseases
Time frame: After 4-week treatment, 4 weeks after discontinuing medication, 8 weeks after discontinuing medication