Effectiveness and safety of light vegetarian diet and Qingjiang Tiaochang Recipe for functional constipation: An exploratory study protocol for randomized controlled trial

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Aged 18-70 years;
2. Meet the Rome IV diagnostic criteria for functional constipation;
3. The stool type is Bristol1, 2 type;
4. Voluntarily participate in this topic and sign the informed consent.

Exclusion Criteria

1. Pregnant women,or women preparing for pregnancy or breastfeeding;
2. Severe heart, brain, and kidney disease, generally poor condition or organ failure;
3. Patients who have been taking drugs that affect constipation for a long time, such as diabetes, hypothyroidism, electrolyte disturbance, and scleroderma;
4. Drugs that cannot affect the gastrointestinal motility / sensory function in the test: such as gastric motility drugs, erythromycin antibiotics, anticholinergics, anesthetic pain agents, antidepressants, calcium channel blockers, diuretics, calcium Agents, iron agents, antidiarrheals, antihistamines, etc.;
5. Took antibiotics or microecological preparations in the last 2 weeks;
6. In the past 6 months, colonoscopy revealed organic intestinal diseases such as intestinal tuberculosis, intestinal obstruction, intestinal tumors, intestinal diverticulum, congenital megacolon, and colonic prolongation (colon polyps <= 3 and Benign lesions with a maximum polyp diameter <= 0.5 cm can be included);
7. With constipation of irritable bowel syndrome.
8. Patients after hysterectomy.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
plete voluntary defecation frequency per week;

Secondary Outcome Measures

Name	Time	Method
high resolution anorectal manometry;Traditional Chinese Medicine syndrome score scale;gastrointestinal transit time;Determination of fecal short-chain fatty acids;constipation-related symptom rating scale;