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Clinical study of Kuiyangyu ointment in the treatment of anal fissure at I and II stages

Clinical study of Kuiyangyu ointment in the treatment of anal fissure at I and II stages

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083855
Enrollment
Unknown
Registered
2024-05-06
Start date
2024-05-06
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

anal fissure

Interventions

Control Group:Nitroglycerin Ointment is applied to the wound once in the morning and once in the evening for a period of 14 days.
Experimental Group:Kuiyangyu Ointment is applied to the wound once in the morning and once in the evening for a period of 14 days.

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet the western medical diagnostic criteria for Stage I and II anal fissure and the Chinese medicine diagnosis of blood-heat and intestinal dryness; (2) Age =18 and =65 years old, gender is not limited; (3) Have not used other topical drugs for anal fissure in the past 1 week; (4) Understand and agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Pregnant or breastfeeding women, allergic individuals and those who are allergic to the drugs involved in this study; (2) Previous history of anal and intestinal diseases and other surgeries, or significant abnormal anal function; (3) Patients with a combination of other perianal diseases, such as mixed hemorrhoids, perianal abscess, anal fistula, colorectal tumours and so on; (4) Patients with inflammatory bowel disease, such as ulcerative colorectitis and Crohn's disease; (5) Combined with cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems and other serious primary diseases and psychiatric patients; (6) Patients with delayed wound healing due to infection with tuberculosis, diabetes mellitus, and various consumptive diseases and seeing moderate to severe malnutrition; (7) Participated in or are participating in other clinical trials in the month before enrolment.

Design outcomes

Primary

MeasureTime frame
Total Effective Rate;

Secondary

MeasureTime frame
Pain scores;Degree of blood in stool;Scoring of granulation tissue growth;Wound healing time;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactLi Ying

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

liying5720@126.com+86 133 0183 1821

Outcome results

None listed

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