Clinical trial · Interventional
Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis
A Randomized,Controlled Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis.
NCT02303197CI-TRIAL-00020283completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study evaluates the efficiency and safety of ChiNing decoction to head and neck cancer patients with radioactive stomatitis. Half of participants will receive ChiNing decoction, while others will receive recombinant human epidermal growth factor (rhEGF) spray.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ChiNing decoction | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ChiNing decoction
- description
- 60ml ChiNing decoction by mouth，three times a day for 46 days.
- interventionNames
- Drug: ChiNing decoction
- type
- NO_INTERVENTION
- label
- rhEGF spray
- description
- The rhEGF spray spray on the oral mucosal surface irradiated area, 3 times a day for 46 days.
Primary outcomes (1)
- measure
- Grading standard of RTOG in acute radiation injury of oral mucosal
- timeFrame
- 8 days
- description
- Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Head and neck cancer patients with pathology and / or cytologic diagnosis; * Age 18\~75 years old; * The expected life is more than 3 months; * The Karnofsky score (Karnofsky) ≥70 points; * The first course of radiotherapy in patients; * Patients had not received any anti tumour therapies for example of operation, radiotherapy,chemotherapy, biological treatment or isotope therapy system; * Patients volunteered to participate in this test and signed the informed consent, understand the purpose and test steps of the test, good compliance, comply with the relevant requirements of this test scheme; * No history of oral ulcer and salivary gland diseases Exclusion Criteria: * That do not meet the above the inclusion criteria; * Advanced critical cases, the expected survival is less than 3 months; * The patients had serious complications, such as cachexia, hepatic encephalopathy, gastrointestinal bleeding and coagulation functionobstruction, su ch as abnormal; * The submandibular gland pathological changes; * During radiotherapy taking other drugs in patients with treatment of stomatitis; * The patients with serious heart, brain, liver, kidney function
References
Publications (5)
- BACKGROUNDRyu SH, Kang KM, Moon SY, Chai GY, Hong JP, Cho KO, Kang MI, Choi EK, Lee SW. Therapeutic effects of recombinant human epidermal growth factor (rhEGF) in a murine model of concurrent chemo- and radiotherapy-induced oral mucositis. J Radiat Res. 2010;51(5):595-601. doi: 10.1269/jrr.10069. PMID 20921827
- BACKGROUNDSpielberger R. Current management of oral mucositis. Clin Adv Hematol Oncol. 2005 Oct;3(10):769-71. No abstract available. PMID 16258486
- BACKGROUNDWang B, Cao SH, Wang YQ. [Effects of modified liangge powder contained serum on LPS stimulated TLR4 expression and release of cytokines in mouse platelets]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2012 May;32(5):681-4. Chinese. PMID 22679734
- BACKGROUNDYu LZ, Jiang AD, Cheng YY, Lin H, Qin QH, Ma XD. [Liangge san effects the expression of CD14 and scaverger receptor in the Kupffer cells of liver of endotoxemia mice]. Zhongguo Zhong Yao Za Zhi. 2006 Feb;31(3):220-3. Chinese. PMID 16573003
- BACKGROUNDJiang AD, Yu LZ, Gong XW, Deng P, Ma XD. [Effect of Liangge San on lipopolysaccharide-induced nuclear factor kappa B activation in cultured mouse macrophages]. Di Yi Jun Yi Da Xue Xue Bao. 2005 Jun;25(6):619-22. Chinese. PMID 15958292