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Omics Analysis and Efficacy Evaluation of Huanglian Jiedu Decoction for Radiation Proctitis in Pelvic Malignant Tumor Patients Based on Gut Microbiota Changes

Omics Analysis and Efficacy Evaluation of Huanglian Jiedu Decoction for Radiation Proctitis in Pelvic Malignant Tumor Patients Based on Gut Microbiota Changes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000811
Enrollment
Unknown
Registered
2024-12-13
Start date
2024-12-15
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Radiation Proctitis

Interventions

control group:Hydrocortisone Retention Enema
Treatment group:Retention Enema with Huanglian Jiedu Decoction

Sponsors

Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with radiation proctitis after radiotherapy for pelvic malignant tumors (including cervical cancer endometrial cancer rectal cancer prostate cancer pelvic bone metastases multiple myeloma etc.); (2) Meets the diagnostic criteria of Western medicine and has clinical manifestations. One item in colonoscopy one item in barium enema or histopathological examination can diagnose this patient. (3) Those who meet the diagnosis criteria of intestinal damp heat syndrome in traditional Chinese medicine; (4) Patients who can tolerate enema treatment; (5) Age above 18 years old and below 75 years old (including boundary values) regardless of gender or ethnicity; (6) Expected survival period = 3 months; (7) Those who voluntarily participate in clinical trials and sign informed consent forms.

Exclusion criteria

Exclusion criteria: (1) Patients with serious complications such as heavy bleeding intestinal obstruction and intestinal perforation; (2) Pregnant or preparing pregnant women; (3) Individuals with allergies or allergies to multiple medications; (4) Patients with severe primary diseases such as liver kidney hematopoietic system endocrine system and psychiatric disorders; (5) The patient's condition is critical and it is difficult to make a precise evaluation of the effectiveness and safety of the medication.

Design outcomes

Primary

MeasureTime frame
16S rRNA;Metabolomics testing;RTOG/EORTC(European Organisation for Research and Treatment of Cancer-Radiation Therapy Oncology Group);

Secondary

MeasureTime frame
ECOG (Eastern Cooperative Oncology Group) Performance Status;Pathological Assessment;Imaging assessment;Serum Inflammatory Markers;Vienna Rectoscopy Score;

Countries

China

Contacts

Public Contactlijing

Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University

27896493@qq.com15682319943

Outcome results

None listed

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