Skip to content

A real-world clinical study on the effectiveness and safety of Fufang Pianzaihuang Hanpian in improving acute pharyngitis acute tonsillitis and related throat discomfort symptoms after radiotherapy for head and neck tumors.

A real-world clinical study on the effectiveness and safety of Fufang Pianzaihuang Hanpian in improving acute pharyngitis acute tonsillitis and related throat discomfort symptoms after radiotherapy for head and neck tumors.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000408
Enrollment
Unknown
Registered
2025-02-25
Start date
2023-08-17
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 pharyngitis acute tonsillitis and post-radiotherapy related throat discomfort symptoms in head and neck tumors.

Interventions

Experimental group:Conventional treatment + Fufang Pianzaihuang Hanpian
Control group:Conventional treatment

Sponsors

Dongfang Hospital Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Those who meet the diagnosis of acute pharyngitis or acute tonsillitis or who receive radiotherapy or radiotherapy based combination therapy for head and neck tumors; (2) Patients need to have the primary disease secondary disease as a reference; Acute pharyngitis main symptoms: sore throat; Secondary symptoms: dry and burning throat. Acute tonsillitis main symptoms: sore throat; Secondary symptoms: burning of the throat. Head and neck tumor radiotherapy main symptoms: pharyngeal pain; Secondary disease: dry throat. (3) Baseline NRS score for pharyngeal pain =4 points; (4) Age =18 years old gender is not limited; (5) The duration of acute pharyngitis and acute tonsillitis should not exceed 48 hours and the duration of head and neck tumor should be within 30 days after the full course of radiotherapy; (6) The patient gives informed consent and signs the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: (1) Patients who have used drugs with similar functions as described in the instructions of Compound Pien Tze Huang Buzenge within 24 hours before treatment; (2) The function of the digestive system is weakened resulting in loose stool stomach discomfort or even pain; (3) Patients with serious circulatory digestive respiratory urinary nervous endocrine and hematopoietic diseases that researchers believe may interfere with clinical evaluation; (4) Body temperature =38.5?; (5) Clearly diagnosed as mental disorders developmental disorders and other patients with no ability to act autonomously; (6) Pregnant or lactating women or patients (including partners) who are ready to conceive in the last 3 months; (7) Those who are known to be allergic to the ingredients of the test drug; (8) Patients who have participated in or are participating in other clinical trials within 1 month; (9) Patients judged by the investigator to be unfit to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
Change from baseline in NRS score for pharyngalgia at the trial endpoint;

Secondary

MeasureTime frame
Area under the curve (AUC) of individual symptom NRS scores over time;Time to disappearance of individual symptoms after treatment;Changes in NRS scores from baseline to each time point of the trial endpoint;Post-treatment Disappearance Rate of Individual Symptoms;The impact of different disease types seasons regions demographic characteristics concomitant medications usage and dosage course of treatment etc. on the change in NRS sore throat scores before and after treatment.;

Countries

China

Contacts

Public ContactJiaxi Wang

Dongfang Hospital Beijing University of Chinese Medicine

13611041381@163.com13611041381

Outcome results

None listed

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