functional diarrhea
Conditions
Interventions
Control group:live combined bifidobacterium,lasctobacillus and enterococcus capsules + medicine granule simulation agent
Treatment group:Modified Ershen Pill + Capsule simulation
Sponsors
Guangming Hospital of Traditional Chinese Medicine in Pudong New District of Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) recurrent mushy or watery stool without apparent stomachache lasting for at least 6 months before diagnosis, loose or watery stool more than 25% and dry stool less than 25% in recent 2 months. (2) pale red and swollen tongue with whitish and greasy coating (3) possible concomitant symptoms: abdominal distension after dinner, decreased appetite and food intake, heavy feeling and fatigue, intolerance of cold and cold limbs; (4)age between 18 years and 70 years; (5) colonoscopy was normal or had no clinically significant abnormal results (e.g.chronic colitis for congestion and edema without ulcers or erosion, colonic polyps of which number was less than 5, diameter was less than or equal to 3mm), when warning symptoms such as hematochezia appeared in recent 5 years; (6) diet and lifestyle had no change which may impact diarrhea possibly after enrollment; (7) during placebo run-in period for 1 week Bristol Stool Scale score was 6 or 7 at least once in two days, emergency drugs (probiotics, montmorillonite powder, Chinese patent medicine for diarrhea such as Changweikang) were taken for no more than 2 days cumulatively, and medication compliance was between 80% and 120% (including boundary value), stool and medication diary was recorded for at least 5 days; (8) Patient must sign an informed consent document before enrollment with the consent of the ethics committee.
Exclusion criteria
Exclusion criteria: (1) apparent stomachache, easy hungry or red eyes; (2) Infectious diarrhea, lactose intolerance, malabsorption syndrome, diverticulitis, colorectal cancer or inflammatory bowel disease; (3) comorbidities like chronic pancreatitis, liver cirrhosis, neoplasms of digestive system, tuberculous peritonitis, hyperthyroidism, diabetes, chronic renal insufficiency, psychosis or neural illness; (4) history of major operations on the liver, pancreas, gallbladder or gastrointestinal; (5) patients with allergic constitution or multiple drug allergies; (6) patients with mental disease who were unable to cooperate to complete the clinical trial; (7) long-term alcohol abuse (8) Drugs were taken after onset of the disease in recent 2 weeks which may affect gastrointestinal function (antidiarrheal, antidepressants, antianxiety drugs, probiotics, antibiotics,etc) (9) pregnant or lactating women (10) patients have participated in other clinical trials within 1 month prior to drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fecal shape and properties ; | — |
Secondary
| Measure | Time frame |
|---|---|
| frequency of defecation;TCM symptom score;recurrences of diarrhea and outpatient visits;Gastrointestinal Symptoms Rating Scales;sf-36;Hamilton anxiety scale; | — |
Countries
China
Contacts
Public ContactChen Yingying
Guangming Hospital of Traditional Chinese Medicine in Pudong New District of Shanghai
Outcome results
None listed