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A Clinical study to evaluate the Efficacy And Safety of Qing Chang Liang Xue Hua Yu Decotion in the prevention and treatment of Acute Radiation Enteritis

A Clinical Study on the Efficacy and Safety of Qingchang Liangxue Huayu Formula for the Prevention and Treatment of Acute Radiation Enteritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000310
Enrollment
Unknown
Registered
2025-02-17
Start date
2022-10-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Acute Radiation Enteritis

Interventions

Treatment group:Radiotherapy plus Oral Qing Chang Liang Xue Hua Yu Decotion

Sponsors

Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1) Patients with abdominal/pelvic or retroperitoneal malignant tumors (rectal cancer cervical cancer) confirmed by histopathology or cytology need radiotherapy; 2) Patients who have not received targeted focal radiotherapy before; 3) KPS score above 60 age 18-90 years old gender is not limited; 4) Expected survival of more than 6 months; 5) Sign the informed consent and volunteer for the test.

Exclusion criteria

Exclusion criteria: 1) Other gastrointestinal diseases such as Crohn's disease or non-specific ulcerative enteritis; 2) Severe complications of blood heart brain liver and kidney system; 3) Intestinal fistula intestinal obstruction etc. requiring surgery; 4) Allergies such as allergies to two or more drugs or food; Or known allergy to the ingredients of the drug; 5) Other diseases that reduce the possibility of enrollment or complicate enrollment such as frequent changes in the working environment are likely to cause loss of follow-up according to the judgment of the investigator; 6) Recent (less than 3 months) participants in other drug clinical trials;

Design outcomes

Primary

MeasureTime frame
Incidence of Acute Radiation Enteritis;Clinical symptom remission rate of acute radiation enteritis;

Secondary

MeasureTime frame
TCM symptom score;Karnofsky Performance Status;RTOG Classification criteria for acute radiation injury;Coagulation function;Routine stool/occult blood test;

Countries

China

Contacts

Public ContactLu Hong

Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine)

redeer@souhu.com+86 18260031620

Outcome results

None listed

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