Irritable Bowel Syndrome With Diarrhea
Conditions
Keywords
IBS-D; Chang'an I Recipe; Placebo
Brief summary
To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of IBS-D. A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Patients were applied for central random number and were given corresponding treatment according to inclusion sequences.The treatment group was administered the Chang'an I Recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo, 150ml/bag, 3 times/day. Both courses of treatment were 8 weeks.
Interventions
DRUGChang'an I Recipe
Patients in this group were administered the Chang'an I Recipe, 150ml/bag, 3 times/day for 8 weeks.
DRUGPlacebo
Patients in this group were administered the placebo, 150ml/bag, times/day for 8 weeks.
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients meeting the diagnostic criteria of Western medicine for IBS-D; * aged 18-70 years old; with a baseline IBS-SSS score over 75 points; * voluntarily signed the informed consent; * local resident who could ensure follow-ups, with basic reading ability.
Exclusion criteria
* Patients with IBS-C, -M, and uncertain forms; * accompanied with serious lesions in major organs including heart, liver, and kidney, hematopoietic system diseases, and tumors; * gastrointestinal organic disease (e.g., chronic pancreatitis), or systemic diseases affecting the digestive tract motion (e.g., hyperthyroidism, diabetes, chronic renal insufficiency, and nervous system diseases); * undergoing or requiring constant use of drugs that may affect gastrointestinal functions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonist, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, and intestinal flora regulating drugs); * with history of abdominal surgery (e.g., cholecystectomy); * with an allergy history of tested drugs or severe allergy history of food; * pregnant and lactating female; * with a history of neurological or psychiatric disorders; * or participating in other clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) | IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks. | Score less than 75 points was considered as in remission, 75\ 175 as mild, 175\ 300 as moderate, and over 300 as severe. |
Secondary
| Measure | Time frame |
|---|---|
| Serum markers regarding liver and kidney function | at baseline and 8 weeks. |
Countries
China
Outcome results
None listed