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A multicenter, double-blind, randomized controlled trial: Traditional Chinese Medicine treatment for ulcerative colitis

Intervention and efficacy evaluation study of Traditional Chinese Medicine for ulcerative colitis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000048
Enrollment
Unknown
Registered
2008-01-17
Start date
2006-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Ulcerative colitis

Interventions

Controlled group:Take mesalazine 1g Qid in active stage. Sustain the treatment for another week after the symptoms relieve. Then take 0.5g Tid and adjust the dosage according to the condition. The tre
Experimental group:Take the intestine-clearing and dissipating dampness formula 2 times a day in the 1st stage. Enema is given once a day for 12 days. Take health-supporting and intestine-clearing for

Sponsors

The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. In accordance with the diagnosis criteria of ulcerative colitis in Western medicine and: (1) clinical type: first onset and chronic recurrence; (2) severity: mild or moderate; (3) phase: active stage; 2. TCM syndrome differentiation: internal accumulation of damp-heat; 3. Aged between 18 and 65 years old, regardless of sex; 4. Informed consents and willing to participant; the obtaining of informed consent document accords with ethics principles.

Exclusion criteria

Exclusion criteria: 1. Disease type: acute fulminant, persistently chronic; severity: severe; 2. Patients with infectious colitis such as bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis, and crohn's disease, ischemic enteritis, radiation enteritis; 3. Patients with severe complications: local stenosis, intestinal obstruction, intestinal perforation, toxic dilation of the colon, massive hemorrhage, colon cancer and rectal cancer; 4. Pregnant or breast-feeding females; 5. Patients with severe primary heart, liver, lung, kidney, hematological diseases or diseases that may influence the survival such as tumor, AIDS, asthma, renal calculi, abnormal renal function; urine protein > +, urinary red cell under microscope.

Design outcomes

Primary

MeasureTime frame
Cure rate and ineffective rate;Relapse rate;Remission rate;

Secondary

MeasureTime frame
quality of life;Safety;

Countries

China

Contacts

Public ContactHong Shen
shenhong999@163.com+86 025 86617141-30916

Outcome results

None listed

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