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Randomized double-blind parallel controlled clinical study of tangerine peel enzyme in the treatment of chronic functional constipation

Randomized double-blind parallel controlled clinical study of tangerine peel enzyme in the treatment of chronic functional constipation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033060
Enrollment
Unknown
Registered
2020-05-19
Start date
2020-05-18
Completion date
Unknown
Last updated
2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic functional constipation

Interventions

Sponsors

Guangdong Provinc Traditional Chinese Medical Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Constipation scale;

Secondary

MeasureTime frame
PAC-QOL;

Countries

China

Contacts

Public ContactXinyan Chen

Guangdong Province Traditional Chinese Medical Hospital

chenxinyancxy@163.com+86 13539984767

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026