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Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child-bearing female with active ulcerative colitis: a randomized, double-blind, controlled trial

A systematic study on the criteria of syndrome differentiation of kidney Yang deficiency in infertility

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039161
Enrollment
Unknown
Registered
2020-10-20
Start date
2020-10-30
Completion date
Unknown
Last updated
2021-01-18

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

Conditions

Ulcerative colitis

Interventions

Sponsors

Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Females, aged between 20 and 45 years; 2. Patients who meet the criteria of active ulcerative colitis (total Mayo score >= 3) 3. Patients preparing for pregnancy; 4. Patients who willing to participate in the study , sign an informed consent and can be followed up.

Exclusion criteria

Exclusion criteria: 1. Patients with infertility caused by diseases of reproductive system or male infertility; 2. Patients with severe complications, such as local stenosis, intestinal obstruction, intestinal perforation, colon cancer, rectal cancer, bacillary dysentery, amebic dysentery, chronic schistosomiasis, radiation enteritis; 3. Patients who are allergic to the known ingredients and any excipients of the drug in this study; 4. Patients with severe diseases such as liver, kidney, hematopoietic system and mental retardation; 5. Patients who have participated in clinical trials of other drugs in recent 3 months.

Design outcomes

Primary

MeasureTime frame
Total Mayo score;

Secondary

MeasureTime frame
pregnancy outcome;relapse rate in pregnancy ;Faecal calprotectin;Mucosal healing rate;Inflammatory Bowel Disease Quality of Life Questionnaire;

Countries

China

Contacts

Public ContactHua Lu

Chengdu University of Traditional Chinese Medicine

1924238034@qq.com+86 13668219665

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 16, 2026