Evaluation on clinical therapeutic effect of induction therapy with Gu Pi Sheng Ji Hua Zhuo Jie Du decoction in Crohn's disease
- Conditions
- Crhon's disease
- Registration Number
- ITMCTR2200006719
- Lead Sponsor
- Guangdong Provincial Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1.meet the criterion of Crohns disease, and had Crohns disease for at least 6 months, with Crohns Disease Activity Index (CDAI) scores between 220 and 400.
2.Willing to sign the informed consent, and able to understand the experimental scheme and cooperate with the experimental scheme.
3.Aged 18-60.
1.received treatment with cyclosporine, methotrexate, or experimental agents within three months before screening.
2.symptomatic stenosis or ileal strictures.
3.stoma.
4.proctocolectomy or total colectomy.
5.a history of allergy to murine proteins.
6.prior treatment with murine,chimeric, or humanized monoclonal antibodies.
7.treatment with parenteral corticosteroids or corticotropin within four weeks before screening.
8.serious complications such as massive hemorrhage of digestive tract, perforation of digestive tract, canceration and intestinal obstruction that are ineffective after conservative medical treatment.
9.Pregnant or lactating patients.
10.patients who can not strictly observe and consciously cooperate with the research requirements of this trial (refer to those who can not cooperate with the diet control or can not use drugs according to the regulations and affect the efficacy).
11.Patients with psychosis.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical efficiency;Mucosa healing rate;Endoscopic response rate;
- Secondary Outcome Measures
Name Time Method erythrocyte sedimentation rate;C-reactive protein;Nutritional status;Fecal occult blood test;Quality of life;faecal calprotectin;