Clinical trial · Interventional
Sancai Fengsui Decoction for RTOM: A Multicenter RCT
A Multicenter Randomized Controlled Trial to Evaluate the Rehabilitative Efficacy of Sancai Fengsui Decoction on Radiation-Induced Oral Mucositis.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
How to promote the prognosis and outcome of RTOM, restore oral function, and improve quality of life are key issues for improving the long-term outcomes of head and neck malignant tumor radiotherapy, and are also integral parts of the patient-centered Traditional Chinese Medicine "prevention-treatment-rehabilitation" system for RTOM. This project aims to thoroughly evaluate the efficacy and safety of Chinese herbal compounds in the rehabilitation phase of RTOM, targeting the long-term rehabilitation outcomes of RTOM, and to conduct a phase II clinical trial. In this project, Sancai Fengsui Decoction will be used as an oral medication to improve the rehabilitation status of RTOM, and will be compared with a placebo group. The efficacy of the oral medication will be evaluated by comparing outcome measures including the 2-week pain relief rate in the oral cavity/oropharynx, the RTOG grade remission rate for RTOM, and the relief rate of xerostomia. As an important extension of TCM prevention and treatment for RTOM, this project can provide a high-level evidence-based TCM protocol for the long-term rehabilitation of RTOM.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Mucositis of RTOG Grade Greater Than 1 | — | UNRESOLVED | — |
| Radiation-Induced Oral Mucositis (RTOM) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Group | Drug | — | UNRESOLVED |
| Sancai Fengsui Decoction | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sancai Fengshui Tang group
- description
- Sancai Fengsui Decoction group: Orally administered Sancai Fengsui Decoction, 30 mL per dose, three times daily, with a treatment course of two weeks.
- interventionNames
- Drug: Sancai Fengsui Decoction
- type
- PLACEBO_COMPARATOR
- label
- Placebo control group
- description
- Placebo group: The control group received a placebo that matched the color, odor, and taste of the Sancai Fengsui Decoction but contained no active ingredients of the decoction. The usage and dosage were the same as those in the Sancai Fengsui Decoction group.
- interventionNames
- Drug: Placebo Group
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Meets the diagnostic criteria for RTOM, with severity classified according to the RTOG grading system; * Voluntarily participates in this study and signs the informed consent form; * Age between 18 and 65 years; * Histopathologically diagnosed with non-metastatic head and neck malignancy; * Has received radiotherapy or concurrent chemoradiotherapy; * ECOG performance status score: 0-2; * Adequate major organ function. * Exclusion Criteria: * Patients with severe heart, lung, liver, kidney, digestive system, hematopoietic system, or nervous system diseases; acute infectious diseases; autoimmune diseases; HIV; diabetes mellitus with poor blood glucose control; or any other serious condition that, in the investigator's judgment, may increase the risk of the study, interfere with study execution or result analysis, or make the subject unsuitable for enrollment for other reasons; * Pregnant or breastfeeding women; * Allergic constitution; * Patients with severe psychiatric disorders, or a history of alcohol or drug abuse; * Participation in another clinical trial within the past 3 months; * Subjects deemed unsuitable for participation in this clinical study by the investigator.
References
Publications (0)
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