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Effect of Huoshan Dendrobium Zengye Jiedu Formula on oral mucositis and quality of life in patients with radiotherapy and chemotherapy

Study on the effect of Dendrobium Zengye Jiedu Formula on the mucositis and quality of life of patients caused by radiotherapy and chemotherapy and the development of hospital preparations

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067760
Enrollment
Unknown
Registered
2023-01-20
Start date
2023-01-20
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Oral mucositis

Interventions

Experimental group:Huoshan Dendrobium Zengye Jiedu Formula
Control group:Kangfuxin liquid

Sponsors

The First Department of Oncology, The First Affiliated Hospital of Anhui University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The age is 18-80 years old, regardless of gender; 2. Patients with oral mucositis diagnosed clinically; 3. Patients with advanced malignant tumors confirmed by cytology or histology pathology are head and neck tumors (including nasopharyngeal cancer, esophageal cancer, etc.), lung cancer, stomach cancer, ovarian cancer, breast cancer, cervical cancer, etc. TNM stage is ? - ?; ECOG score 0~1; The expected survival period is more than 6 months; 4. Those who have experienced radiotherapy or chemotherapy or concurrent radiotherapy and chemotherapy (the chemotherapy plan includes at least one or more of cyclophosphamide, methotrexate, nitrogen mustard, cisplatin, gemcitabine, cytarabine, vinblastine, podophyllotoxin, paclitaxel and other drugs) shall undergo chemotherapy; 5. The patient has clear consciousness, language expression ability or reading ability, can communicate normally, and can cooperate to complete the assessment; 6. Volunteer to join the study, the patient has good compliance, can understand the situation of the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who are known to be allergic to the components of this drug; 2. Those who do not conform to the diagnosis or whose diagnosis is unclear; 3. Patients with primary immunodeficiency disease and other serious infectious diseases, and patients treated with immunomodulator; 4. Patients with abnormal blood routine, liver function and renal function; 5. Pregnant or lactating women, and people with mental disorders; 6. Poor compliance; 7. For other reasons, the researcher thinks it is not suitable to participate in this study; 8. Patients who have taken other trial drugs or are in other clinical trials in the past month cannot be selected.

Design outcomes

Primary

MeasureTime frame
Pain digital scoring;Inappropriate score;WHO classification of oral mucositis;Core scale score of quality of life for cancer patients;Immune function test;

Secondary

MeasureTime frame
Tumor markers;routine blood test;

Countries

China

Contacts

Public ContactZhu Yongfu

The First Affiliated Hospital of Anhui University of Chinese Medicine

49939181@qq.com+86 138 6671 0495

Outcome results

None listed

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