Diarrhea-predominant irritable bowel syndrome
Conditions
Interventions
experimental group:Oral Jianpi Yanggan Pill
control group:oral bifidobacterium bifidum Lactobacillus triplex tablets
Sponsors
The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Western medical diagnostic criteria. Referring to the "IBS-D Rome IV Diagnostic Criteria" published by the Rome Commission in 2016, the diagnostic criteria are recurrent abdominal pain, with episodes of at least 1 day per week in the last 3 months, accompanied by 2 or more of the following: (1)Associated with defecation; (2) Accompanied by a change in the frequency of defecation; (3)Accompanied by a change in fecal character (appearance): >1/4 (25%) of the bowel movements are Bristol fecal character type 6 or 7 and <1/4 (25%) of the bowel movements are Bristol fecal character type 1 or 2 (refer to Exhibit 4), the symptoms have been present for at least 6 months prior to the diagnosis and the above diagnostic criteria have been fulfilled in the last 3 months. 2. Diagnostic criteria of Chinese medicine: The diagnostic criteria of Chinese medicine "diarrhea disease (liver depression and spleen deficiency)" were met; Diarrhea-type irritable bowel syndrome belongs to the category of "diarrhea disease" in traditional Chinese medicine, and the TCM diagnostic criteria for IBS-D patients included in this study were formulated with reference to the "Expert Consensus Opinions on Chinese Medicine Diagnosis and Treatment of Irritable Bowel Syndrome (2017)", which refers to the "Liver Depression and Spleen Deficiency Certificate" of the Diarrhea Disease. Primary symptoms: (1) abdominal pain i.e. diarrhea, pain reduction after diarrhea; (2) impatience and irritability. Secondary symptoms: (1) distension and fullness in both sides; (2) dullness; (3) tiredness. Tongue and pulse: tongue is pale and fat, may also have teeth marks, moss is thin and white; pulse is stringy. Diagnosis: 2 main symptoms, plus 2 secondary symptoms, refer to the tongue and pulse, then diagnosis can be made. 3. The age range of the subjects is between 18-70 years old; 4. patients with cognitive ability, can actively cooperate to ensure the continuity of treatment and regular follow-up; 5. colonoscopy (pathological biopsy if necessary), the results suggest no organic lesions, the timeliness of the examination is limited to within the last six months; 6.fecal routine + fecal occult blood, blood routine, urine routine, liver function, renal function, electrocardiogram did not see obvious abnormalities; 7.Subjects understand the significance of participating in this subject and the possible adverse reactions in clinical research, and voluntarily join the experiment and sign the informed consent, the process of obtaining informed consent should be in accordance with the provisions of the Good Clinical Practice (GCP) for drug clinical trials.
Exclusion criteria
Exclusion criteria: 1. Those with a known history of drug abuse or alcoholism; or those who are allergic to the test drug; 2. diarrhea caused by systemic diseases, poisoning, parasitic infections, malignant tumors and other causes; 3. those who are allergic to this drug, or taking other Chinese medicines or mosapride, etc. that affect the determination of the results; 4. Combined cardiovascular, cerebrovascular, hepatic, renal, endocrine, autoimmune diseases and hematological system and other organic diseases, long-term use of immunosuppressants, pneumoconiosis, patients with mental illness and drug addicts; 5. People suffering from schizophrenia, epilepsy and other serious mental illness or critical condition, it is difficult to make a precise statement on the effectiveness and safety of the drug; 6. Pregnant or lactating persons; 7. Those who are participating in other clinical studies although meeting the diagnostic criteria of Chinese and Western medicine; 8. Those whose incomplete information affects the judgment of efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal Pain Symptoms Score;Diarrhea Symptoms Score;Irritable Bowel Syndrome Symptom Severity Score;Grading of Chinese Medicine Symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| intestinal flora;IBS Quality of Life Questionnaire scores;Hamilton Anxiety Score;serum inflammatory factor; | — |
Countries
china
Contacts
Public ContactKe Ma
The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Outcome results
None listed