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Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type

Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036950
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-28

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

Conditions

Uicerative colitis

Interventions

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. According to the diagnostic criteria of Western medicine for ulcerative colitis, the clinical severity is mild to moderate; the lesions include rectum, left colon or extensive colon; the clinical types are primary or chronic relapse; 2. TCM syndrome differentiation belongs to spleen deficiency damp heat type; 3. They are between 18 and 75 years old; 4. The patient voluntarily participated in the clinical trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with chronic persistent, fulminant and severe ulcerative colitis. 2. Patients with infectious colitis such as bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis, Crohn's disease, ischemic enteritis and radiation enteritis. 3. Patients have serious complications, such as local stenosis, intestinal perforation, intestinal obstruction, massive hemorrhage, toxic megacolon, colorectal cancer and so on. 4. Combined with heart, liver, kidney, hematopoietic system, endocrine system and other serious primary diseases and mental patients. 5. Pregnant or preparing pregnant women, lactating women, allergic constitution and allergic to this drug. 6. Those who have been treated with hormone therapy or other related drugs or are participating in other clinical trials. 7. Suspected or confirmed history of alcohol and drug abuse. 8. Those who do not cooperate with the treatment and cannot judge the curative effect.

Design outcomes

Primary

MeasureTime frame
clinical efficacy rate;

Secondary

MeasureTime frame
clinical remission rate;endoscopic response rate;mucosal healing rate;TCM syndrome efficacy;laboratory index;quality of life;emotion evaluation;

Countries

China

Contacts

Public ContactWeiwei Hao
hwwwork@163.com+86 021-65161782

Outcome results

None listed

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