Functional Constipation
Conditions
Interventions
Li-Qi Run-Chang Granule Group:Li-Qi Run-Chang Granule
Lactulose group:Lactulose Oral Solution
Sponsors
The First Affiliated Hospital of Guangdong Pharmaceutical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: ?. Meet the Rome IV diagnostic criteria for functional constipation; 1) Symptoms of constipation have been present for at least six months and have had episodes in the last three months, and must also include two or more of the following: a. Bowel movements felt labored on at least 1 of 4 occasions; b. Fecal matter that is hard or lumpy on at least 1 of 4 bowel movements; c. At least 1 of 4 bowel movements is characterized by a feeling of incomplete evacuation; d. At least 1 out of 4 bowel movements accompanied by a feeling of anal obstruction; e. At least 1 out of 4 bowel movements requires manual assistance; f. Spontaneous defecation less than 3 times per week. 2). Few loose stools when laxatives are not used; 3). Rule out constipated irritable bowel syndrome; 4). Rule out intestinal or systemic organic disease; 5). Exclusion of opioid-induced constipation. ? Consistent with the TCM diagnosis of this study; Symptoms were formulated as follows based on the Expert Consensus Opinion on Chinese Medicine Diagnosis and Treatment of Constipation issued by the Spleen and Stomach Disease Branch of the Chinese Society of Traditional Chinese Medicine in 2017: Primary symptoms: weakness of defecation, dry stools, sweating from struggling Secondary symptoms: abdominal distension, abdominal pain, dry mouth and desire to drink, and fatigue. The diagnosis can be made if one of the above symptoms meets one of the primary symptoms and one of the secondary symptoms meets one of the secondary symptoms. ?. Age range from 18 to 80 years old, regardless of gender; ?. Agree to sign the informed consent form.
Exclusion criteria
Exclusion criteria: Those who met any of the following were not included for clinical observation: ? Patients with a history of gastrointestinal surgery or significant surgical indications in the three months prior to screening; ? Patients with organic lesions of the colon such as tumors, polyps intestinal tuberculosis, etc. that cause constipation due to narrowing of the intestinal tract; ?Patients diagnosed with active diverticulum, severe hemorrhoids, anal fissure, artificial rectum or anus; ?Women who are pregnant or preparing for pregnancy, and breastfeeding women; ? Diagnosis of pelvic diseases considered to have a significant effect on fecal intestinal transport (e.g., uterine prolapse = degree 2, uterine fibroids [located in the posterior part of the uterus and = 5 cm in diameter] affecting defecation); (vi) Chinese medicine allergy, with severe cognitive impairment and mental abnormality; (vii) Those with hyperthyroidism, severe hypertension, heart disease, systemic infection or coagulation dysfunction (hypercoagulable state or bleeding tendency) or with other serious heart, brain, liver, kidney and blood system diseases; ? Patients with poor compliance and concurrent participation in other research programs within the last month; ? Patients who are receiving treatment for constipation or have taken drugs with similar efficacy or affecting the evaluation of the efficacy of this study within the last week; ? Patients who, based on other relevant therapeutic and medical findings, are considered by the investigator to be ineligible for the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete spontaneous bowe movements; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bristol Classification of faecal traits;Mean score on the chronic constipation severity scale;Total score of constipation patients' quality of life scale (PAC-QOL);Anorectal manometry score;intestinal flora;Hamilton Anxiety Scale;Hamilton Depression Scale;TCM Syndrome Scale of Glycolipid Metabolism;fasting blood sugar;Blood lipid;blood pressure;Routine electrocardiogram;Serum specimen metabolomics full-spectrum detection; | — |
Countries
China
Contacts
Public ContactGuo Jiao
The First Affiliated Hospital of Guangdong Pharmaceutical University
Outcome results
None listed