Randomized double-blind parallel controlled clinical study of tangerine peel enzyme in the treatment of chronic functional constipatio
- Conditions
- chronic functional constipation
- Registration Number
- ITMCTR2000003314
- Lead Sponsor
- Guangdong Provinc Traditional Chinese Medical Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Subjects aged 18-75 years;
2. Subjects with the diagnosis of chronic functional constipation;
3. Volunteers who are willing to participate in the research and sign informed consent.
1. Patients taking defecation drugs within 2 weeks before enrollment.
2. Patients with constipation caused by organic diseases: intestinal diseases (colon tumor, diverticulum, intestinal stenosis or obstruction, megacolon, colorectal surgery, volvulus, rectocele, rectal prolapse, hemorrhoids, anal fissure, perianal abscess and fistula, levator ani syndrome, spasmodic rectocentelgia);
3. Patients with endocrine and metabolic diseases (severe dehydration, diabetes, hypothyroidism, hyperparathyroidism, multiple endocrine adenomas, heavy metal poisoning, hypercalcemia, hyperor hypomagnesemia, hypokalemia, porphyria, chronic kidney disease, uremia);
4. Patients with nervous system diseases (autonomic neuropathy, cerebrovascular disease, cognitive impairment or dementia, multiple sclerosis, Parkinson's disease, spinal cord injury);
5. Patients with muscle diseases (amyloidosis, dermatomyositis, scleroderma, systemic sclerosis)
6. Patients with drug-induced constipation: antidepressants, antiepileptics, antihistamines, anti tremors and paralysis drugs, antipsychotics, antispasmodics, calcium antagonists, diuretics, monoamine oxidase inhibitors, opioids, sympathomimetics, antacids containing aluminum or calcium, calcium, iron, antidiarrheal, non steroidal anti-inflammatory drugs.
7. Patients with heart, liver, kidney, hematopoietic system, immune system and other systemic serious diseases.
8. Pregnant or lactating women or those who plan to be pregnant during the trial period or their spouses plan to be pregnant.
9. Patients with allergic constitution, alcohol allergy, possible allergy to the drug or mental illness.
10. Other objects that cannot be cooperated for a long time.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Constipation scale;
- Secondary Outcome Measures
Name Time Method PAC-QOL;