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The Clinical Efficacy of the Efficacy of Qihu Qingjie Formula in Treating Radiation-Induced Oral Mucositis

The R&D of Novel Traditional Chinese Medicine QiHuQingjie Granulesfor the Treatment of Radiation Induced Oral Mucositis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001898
Enrollment
Unknown
Registered
2025-10-15
Start date
2025-05-09
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Radiation Induced Oral Mucositis

Interventions

Treatment group 1:Radiotherapy plus QiHuQingJie Decotion No. 1
Treatment group 2:Radiotherapy plus QiHuQingJie Decotion No. 2

Sponsors

The affiliated hospital of Hunan Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients with malignant head and neck tumors undergoing radiotherapy or chemoradiotherapy. Radiotherapy dose = 50 Gy. Expected survival of more than 3 months. The subject has a relatively good physical condition with a Karnofsky Performance Status (KPS) score = 70. Age = 18 years. Before radiotherapy peripheral blood leukocytes = 3.0×10^9/L; neutrophils = 1.5×10^9/L; hemoglobin = 90 g/L; platelets = 75×10^9/L.

Exclusion criteria

Exclusion criteria: Failure to meet the inclusion criteria. Pregnant or breastfeeding women. Patients with mental illness. Individuals with an allergic constitution or known allergies to traditional Chinese medicine.

Design outcomes

Primary

MeasureTime frame
RTOG Classification criteria for acute radiation injury;Radiotherapy completion rate;Incidence of radiation-induced oral mucositis;

Secondary

MeasureTime frame
NRS score;Karnofsky Performance Status;Weight;TCM symptom score;

Countries

China

Contacts

Public ContactPeng Yan-mei

Hunan Academy of Chinese Medicine

271853145@qq.com13807495959

Outcome results

None listed

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