Inclusion criteria
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①In accordance with the Rome IV functional constipation diagnostic criteria:
1) The symptoms of constipation have persisted for at least six months, with occurrences in the last three months, including two or more of the following:
a. Experiencing difficulty in bowel movements at least four times, with at least one instance being strenuous.
b. Having hard or lumpy stool at least four times, with at least one instance being hard.
c. Feeling of incomplete evacuation during bowel movements at least four times.
d. Sensation of anal blockage during bowel movements at least four times.
e. Requiring manual assistance for bowel movements at least four times.
f. Spontaneous bowel movements occurring less than three times per week.
2) Loose stools are infrequent when laxatives are not used.
3) Exclusion of constipation-predominant irritable bowel syndrome.
4) Exclusion of organic or systemic diseases affecting the gastrointestinal tract.
5) Exclusion of constipation caused by opioids.
②. In accordance with the traditional Chinese medicine diagnosis for this study:
According to the 2017 Consensus Opinion of the Gastrointestinal Disease Branch of the Chinese Association of Chinese Medicine, the proposed symptoms are as follows:
Main Symptoms: difficulty in bowel movements, dry and hard stool, straining with perspiration.
Secondary Symptoms: abdominal distention, abdominal pain, dry mouth with desire to drink, fatigue.
Diagnosis can be made if one main symptom and one secondary symptom are present.
③. The age range is between 18 and 80 years, regardless of gender.
④. Willingness to sign the informed consent form.
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Exclusion criteria:
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Exclusion criteria for clinical observation are as follows:
1. Individuals with a history of gastrointestinal surgery or significant surgical indications in the three months prior to screening.
2. Patients with organic colonic lesions such as tumors, polyps, or colonic tuberculosis causing intestinal obstruction and constipation.
3. Patients diagnosed with active diverticulosis, severe hemorrhoids, anal fissures, or those with artificial rectum or anus.
4. Women who are pregnant or planning to become pregnant, as well as lactating women.
5. Diagnosis of pelvic diseases believed to have a significant impact on fecal colonic transit (e.g., uterine prolapse ≥ grade 2, uterine fibroids [located in the posterior uterus, diameter ≥ 5 cm] affecting defecation).
6. Individuals with a predisposition to Chinese medicine allergies, severe cognitive impairments, or psychiatric abnormalities.
7. Patients with hyperthyroidism, severe hypertension, heart disease, systemic infections, or coagulation disorders (hypercoagulable state or bleeding tendency), or those with other severe conditions affecting the heart, brain, liver, kidneys, or hematological system.
8. Poor compliance, patients involved in other research projects in the past month.
9. Patients currently undergoing treatment for constipation or those who have taken similar medications with effects that may impact the evaluation of this study's efficacy within the past week.
10. Patients deemed ineligible for the study based on other relevant treatments and medical findings by the researchers.
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