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Efficacy evaluation of Tongyangxiao Lotion in regulating intestinal flora in patients with anal sinusitis of damp-heat downward flow syndrome

Efficacy evaluation of Tongyangxiao Lotion in regulating intestinal flora in patients with anal sinusitis of damp-heat downward flow syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002547
Enrollment
Unknown
Registered
2025-12-27
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

anal sinusitis

Interventions

Tongyangxiao group:Tongyangxiao Lotion

Sponsors

Hebei Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for anal sinusitis: 1) Meets the diagnostic criteria of anal sinusitis; 2) Meets the diagnostic criteria for traditional Chinese medicine damp-heat syndrome of anal sinusitis; 3) Age range is 18-65 years old, with no gender restrictions; 4) Good medical compliance, able to accept retention enema therapy, and have an operational skills for oneself or family members (and caregivers); 5) Voluntarily participate in this study and sign the consent form. Inclusion criteria for healthy volunteers: 1) No history of serious chronic disease (such as diabetes, tumor, chronic kidney disease, serious mental disease, etc.), and no obvious abnormality is found in routine examination; 2) 18-65 years old; 3) No symptoms and signs related to anal sinusitis;

Exclusion criteria

Exclusion criteria: 1) Combining other perianal diseases such as perianal abscess, anal fistula, grade III or above mixed hemorrhoids, old anal fissures, or a history of perianal surgery within the past six months; 2) Patients with combined intestinal inflammatory diseases such as ulcerative colitis and Crohn's disease; 3) Individuals with severe organ dysfunction, severe cardiovascular and cerebrovascular diseases, and other primary illnesses; 4) Individuals with systemic immune or hematological diseases, or those with malignant tumors or infectious diseases; 5) Pregnant and lactating women; 6) Individuals with severe mental illness or cognitive impairment; 7) Regarding the use of relevant drugs in this study and the examination of individuals with allergies or intolerance, or those with a predisposition to allergies; 8) Patients participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Efficacy index;Total effective rate;

Secondary

MeasureTime frame
Bristol stool classification;Recurrence rate;gut microbiota;

Countries

China

Contacts

Public ContactLinyue Wang

Hebei Provincial Hospital of Chinese Medicine

wly95_07@126.com+8619203110800

Outcome results

None listed

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