ITMCTR2100004775招募中1 期
Study on the intestinal microecology with ''Formula Syndrome'' of TCM for diarrehea-predominant pattern irritable bowel syndrome by the technology of metagenomics
Chengdu University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •Western medicine inclusion criteria:
- •1.Those who met the diagnostic criteria of Western medicine for diarrhea predominant irritable bowel syndrome;
- •2.The most severe abdominal pain score in the past 24 hours, with a weekly average of >= 3 points (11 point pain digital rating scale); At the same time fecal traits at least 2 days a week at least once fecal traits Bristol fecal traits scale type 6 or 7;
- •3.IBS-SSS score > 75;
- •4.The age is between 18 and 65 years old (including 18 and 65 years old), regardless of gender;
- •5.Voluntary treatment and informed consent were signed;
- •6.Resident in the local, can ensure treatment follow-up, have a certain reading ability. Only those who meet the above criteria can enter the next stage of syndrome screening.
- •TCM inclusion criteria, liver depression and spleen deficiency syndrome TCM inclusion criteria of the main symptoms:
- •Main symptoms:1.Abdominal pain wants to defecate, and the pain is relieved after defecation; 2.Temper tantrums are easy to be angry.
- •Secondary symptoms:1.Fullness under both flanks; 2.Poor appetite; 3.Exhaustion.
- •Tongue coating pulse:1.The tongue is fat, the tongue color is pale, there are tooth marks on the edge of the tongue, and the tongue coating is thin and white; 2.The pulse string is thin.
- •Dialectical requirements: With 2 main symptoms, 2 secondary symptoms, and tongue and vein in line with.
- •Inclusion Criteria of Spleen Deficiency and Dampness Syndrome in TCM:
- •Main symptoms:1.More stool frequency, stool is not formed; 2.Abdominal dull pain.
- •Secondary diseases:1.Attack or aggravation after exertion or catching cold; 2.Fatigue; 3.Poor appetite.
- •Tongue pulse:1.Pale tongue, teeth marks on the edge of the tongue, white and greasy tongue coating; 2.Weak pulse.
- •Dialectical requirements:With 2 main symptoms, 2 secondary symptoms, and tongue and vein in line with.
排除标准
- •Western medicine exclusion criteria:
- •1.Constipation type, mixed type, atypical irritable bowel syndrome and other organic diseases of digestive system, or other organic diseases causing abdominal pain and discomfort;
- •2.It was confirmed by examination as infectious diarrhea, inflammatory bowel disease, parasitic infection, positive fecal occult blood, colorectal tumor, malabsorption syndrome, lactose intolerance (combined with history) and diarrhea caused by systemic diseases;
- •3.Patients with diabetes mellitus, hyperthyroidism, or severe primary diseases such as heart, brain, liver, kidney, hematopoietic system, or severe diseases affecting their survival (such as tumor), or abnormal liver and kidney functions (BUN, Cr) (alt, AST > 1.5 times of the upper limit of normal range, Cr > the upper limit of normal range), and patients with abnormal ECG of clinical significance;
- •4.Patients with history of nervous system disease and mental illness;
- •5.Previous gastrointestinal surgery (except caesarean section and appendectomy);
- •6.Patients are or need to continue to use drugs that may affect gastrointestinal motility (anticholinergic drugs, 5-HT3 receptor antagonists, antidiarrheal agents, antacids, prokinetic drugs, antidepressants, anxiolytics, intestinal flora regulators, etc.), or those who have used other traditional Chinese and Western drugs for the treatment of irritable bowel syndrome in the past 2 weeks;
- •7.Allergic constitution, with a history of drug allergy and severe food allergy;
- •8.Suspect or have a history of alcohol or drug abuse;
- •9.Pregnant and lactating women, and those with recent pregnancy planning;
- •10.Cognitive impairment, can not give full informed consent;
- •11.Patients who participated in other clinical trials in the past one month;
- •12.The researchers believe that there are patients who are not suitable for inclusion.
- •TCM inclusion criteria:
- •Exclusion criteria of combined syndrome of liver depression and spleen deficiency:
- •Damp-heat, heavy head, chest distress, greasy mouth, limb drowsiness or soreness; yellow and greasy tongue coating. Patients met the above two items could not be included in this study.
- •Spleen and stomach deficiency cold syndrome, stomach dull pain, fasting aggravated, relieved after eating, like to press, vomiting water; hands and feet are not warm, stool is not formed. Patients met the above two items could not be included in this study.
- •Stagnation of liver-qi, fever, aversion to fever; thirst like to drink cold water, sweating; dry stool or constipation, small urine volume color yellow, red complexion; purple red tongue, yellow or grayish black tongue coating and dry, increased pulse rate, strong pulsation. Patients met the above two items could not be included in this study.
- •Kidney yin deficiency, waist and knee pain; vertigo and tinnitus; male spermatorrhea; female menstrual disorders; fever due to yin deficiency. Patients met the above two items could not be included in this study.
- •Kidney deficiency, soreness and weakness of waist and knees, exhaustion; more times of urination, clear urine, or incomplete emptying, or enuresis, or more times of urination at night, or urinary incontinence; men slippery sperm, premature ejaculation, women with long duration of menstruation, or leucorrhea, or easy abortion of the fetus; pale tongue, white tongue coating, weak pulse. Patients met the above two items could not be included in this study.
- •Kidney yang deficiency, male impotence, p
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