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To evaluate the efficacy and safety of Xiaozhi Ointment in the treatment of I~II degree hemorrhoids, compared with Ma Yinglong Musk Hemorrhoids Ointment: a prospective, multicenter, randomized, blind management, parallel control of positive drugs and excellent clinical study.

To evaluate the efficacy and safety of Xiaozhi Ointment in the treatment of I~II degree hemorrhoids, compared with Ma Yinglong Musk Hemorrhoids Ointment: a prospective, multicenter, randomized, blind management, parallel control of positive drugs and excellent clinical study.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002188
Enrollment
Unknown
Registered
2025-11-17
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

I ~ II degree hemorrhoids

Interventions

Experimental group:Xiaozhi ointment
Control group:Ma Yinglong musk hemorrhoid ointment

Sponsors

Chengdu University of Traditional Chinese Medicine Affiliated Hospital Jinniu District Chengdu City Sichuan Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age =18 years and =65 years; 2. Patients who meet the I ~ II degree hemorrhoid diagnosis in western medicine; 3. Agree to participate in this clinical study and sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. Accompanied by other anal diseases and serious organic diseases: (1) Anorectal and rectal diseases, such as anal fissure, anal fistula and perianal abscess; (2) Acute gastrointestinal infection or a history of serious gastrointestinal diseases, such as Crohn's disease, ulcerative colitis, digestive tract ulcer, gastrointestinal bleeding, digestive system tumor, pyloric stenosis, etc.; (3) Liver failure or renal failure; (4) Persons with a history of mental illness or neurological dysfunction; (5) Patients with serious systemic diseases (especially untreated); (6) Patients with thromboembolic diseases and patients with high risk of thrombosis (for example, patients with known hereditary thrombosis tendency or patients with multiple risk factors, such as hormonal contraceptives or hormone replacement therapy, obesity, smoking and long-term inactivity); 2. Drug-related: (1) Patients with known history of drug allergy in this study; (2) Coagulation disorder or taking antiplatelet drugs or anticoagulant drugs; (3) Patients with alcohol and drug dependence; (4) used all kinds of ointments within one month before joining the group; 3. Pregnant women, lactating women or those who cannot use contraception during the study period; 4. Other circumstances that the researcher thinks are not suitable for participating in the study.

Design outcomes

Primary

MeasureTime frame
Comprehensive curative effect of treating diseases after 7 days.;

Secondary

MeasureTime frame
Changes of total scores of symptoms and signs and scores of individual symptoms and signs compared with baseline after 7 days of treatment.;The disappearance rate of individual symptoms and signs after 7 days of treatment.;The disappearance time of bloody stool and anal pain.;Four weeks after drug withdrawal, hematochezia, anal pain, prolapse of hemorrhoid nucleus and recurrence rate of hemorrhoids were observed.;

Countries

China

Contacts

Public ContactKang Jian

Hospital of Chengdu University of Traditional Chinese Medicine

77196719@qq.com18908092665

Outcome results

None listed

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