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A randomized controlled study on the treatment of ulcerative colitis with fatigue in patients with spleen deficiency and damp-heat type by Jianpi-Qingchang decoction

A randomized controlled study on the treatment of ulcerative colitis with fatigue in patients with spleen deficiency and damp-heat type by Jianpi-Qingchang decoction

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068348
Enrollment
Unknown
Registered
2023-02-15
Start date
2023-02-20
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

ulcerative colitis

Interventions

Test group:Jianpi-Qingchang decoction+Mesalazine

Sponsors

Shanghai Traditional Chinese MedicineIntegrated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-70 years, both sexes. (2) All patients were diagnosed with ulcerative colitis by e-colonoscopy and pathology, and the diagnosis was in accordance with the criteria established in the Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018) . (3) Meet the criteria for the identification of spleen deficiency and damp-heat evidence in Chinese medicine in the 2018 Guidelines for the Treatment of Ulcerative Colitis, a Common Disease of the Digestive System . (4) Have had a colonoscopy within the last 1 year. (5) No serious heart, liver, kidney or other important organ and hematologic disorders. (6) The patient fully understands the purpose and content of the test, has good compliance, and voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Have participated in other clinical trials within the last 6 months. (2) Have taken antibiotics within the last 3 months. (3) Within the last 4 weeks have used immunosuppressive agents, biological agents, other non-steroidal (steroidal) anti-inflammatory drugs, the gastrointestinal mucosal protective agents, intestinal probiotics, prebiotic preparations. (4) The presence of liver and kidney insufficiency (test indicators exceeding the upper limit of 2 times). (5) Women during lactation and pregnancy. (6) Gastric and duodenal ulcers, history of intestinal surgery, intestinal obstruction, intestinal perforation, perianal abscess, severe bleeding disorders, tumors. (7) Patients with mental illness, unable to control themselves or who do not have autonomy (8) Patients who do not have legal capacity or whose legal capacity is limited (9) Patients with a history of other medical conditions that, in the investigator's assessment, may interfere with the results of the trial or increase patient risk. (10) Any other condition that, in the opinion of the investigator, makes participation in the study inappropriate.

Design outcomes

Primary

MeasureTime frame
Fatigue Scale,FS-14;Disease activity index;

Secondary

MeasureTime frame
Inflammatory Bowel Disease Questionnaire, IBDQ;Evaluation criteria for curative effect of TCM symptoms;

Countries

China

Contacts

Public ContactDai yan cheng

Shanghai Traditional Chinese Medicine Integrated Hospital

daiyancheng2005@163.com13795294873

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026