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Evaluation on clinical therapeutic effect of induction therapy with Gu Pi Sheng Ji Hua Zhuo Jie Du decoction in Crohn's disease

Evaluation on clinical therapeutic effect of induction therapy with Gu Pi Sheng Ji Hua Zhuo Jie Du decoction in Crohn's disease

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006719
Enrollment
Unknown
Registered
2022-10-28
Start date
2022-10-31
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Crhon's disease

Interventions

experimental group:Chinese herbal decoction+partial enteral nutrition

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Clinical efficiency;Mucosa healing rate;Endoscopic response rate;

Secondary

MeasureTime frame
erythrocyte sedimentation rate;C-reactive protein;Nutritional status;Fecal occult blood test;Quality of life;faecal calprotectin;

Countries

China

Contacts

Public ContactJiaming He
93208383@qq.com13826037809

Outcome results

None listed

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