A Phase 3 interventional study of Modified Dahuang Huanglian Xiexin Mouthwash and Placebo Mouthwash in Radiotherapy-Induced Oral Mucositis, Stomatitis and Oral Mucositis, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Phase 3, Interventional, and Prevention
This is a multicenter, randomized, controlled, prospective clinical trial designed to observe and evaluate the safety and efficacy of Modified Dahuang Huanglian Xiexin Mouthwash for the prevention of radiotherapy-induced oral mucositis (RTOM).
Participants will be randomly assigned to receive either the Modified Dahuang Huanglian Xiexin Mouthwash or Placebo Mouthwash. The study aims to assess the preventative effect on RTOM in patients undergoing radiotherapy.
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
This study's planned enrollment of 156 is above the median of 60 across 276 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 181 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate major organ function as defined by the following criteria (within 14 days prior to enrollment, without transfusion support):
(Hb) ≥90 g/L (ANC)≥1.5×10⁹/L count (PLT) ≥80×10⁹/L Total (BIL) \< 1.25× (ULN) (ALT) and aspartate aminotransferase (AST) \< 2.5×ULN Serum creatinine (Cr)≤ULN, or calculated (Cockcroft-Gault formula) > 50 mL/min
Exclusion Criteria:
Uncontrolled cardiac conditions or symptoms, including but not limited to:
(NYHA) class II or higher heart failure Unstable angina pectoris Myocardial infarction within 1 year prior to enrollment supraventricular or ventricular arrhythmia requiring intervention
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo mouthwash matching the active intervention in appearance, color, taste, and packaging, containing no active pharmaceutical ingredients. It consists of purified water, pharmaceutical-grade coloring and flavoring agents to mimic the characteristics of the Modified Dahuang Huanglian Xiexin Mouthwash. Patients in this arm are instructed to rinse with 10 mL of the placebo solution for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing throughout the radiotherapy course. All participants receive the same radiotherapy regimen and standard oral care. This arm serves as a control to evaluate the efficacy of the active intervention under double-blind conditions.
Drug: Placebo Mouthwash
Modified Dahuang Huanglian Xiexin Mouthwash (Jiawei Dahuang Huanglian Xiexin Koufuye), an active Chinese herbal formulation. Patients in this arm are instructed to rinse with 10 mL of the active solution for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing throughout the radiotherapy course. All participants receive the same radiotherapy regimen and standard oral care. This arm serves as the experimental intervention to evaluate its efficacy in reducing radiation-induced oral mucositis compared with a matched placebo under double-blind conditions.
Drug: Modified Dahuang Huanglian Xiexin Mouthwash
A Chinese herbal mouthwash formulation derived from the classic formula Dahuang Huanglian Xiexin Decoction, with additional ingredients to enhance its properties for radiation-induced oral mucositis. The active ingredients include Rhei Radix et Rhizoma, Coptidis Rhizoma, Scutellariae Radix, and other botanical components. It is prepared as a ready-to-use aqueous solution with standardized extraction and quality control procedures. The mouthwash is administered as 10 mL per use, held in the oral cavity for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing until the development of grade 3 or higher oral mucositis, as defined by the WHO or RTOG criteria. This intervention is distinguished from the placebo comparator by the presence of active herbal ingredients, and its appearance, color, taste, and packaging are matched by the placebo to enable double-blind conditions.
A placebo mouthwash formulated to match the active intervention (Modified Dahuang Huanglian Xiexin Mouthwash) in appearance, color, taste, and packaging. It contains no active pharmaceutical ingredients and is composed of purified water with pharmaceutical-grade coloring and flavoring agents to mimic the characteristics of the herbal formulation. The mouthwash is supplied as a ready-to-use aqueous solution. It is administered as 10 mL per use, held in the oral cavity for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing throughout the radiotherapy course. This intervention is distinguished from the active comparator by the absence of active herbal ingredients and serves as a control to enable double-blind evaluation.
Incidence of Radiation-Induced Oral Mucositis Within 2 Weeks of Radiotherapy Initiation
Proportion of participants who develop radiation-induced oral mucositis (RTOM) of any grade within 2 weeks after the start of radiotherapy, assessed using the WHO Oral Toxicity Scale or RTOG Acute Radiation Morbidity Scoring Criteria. Participants who develop grade ≥3 RTOM prior to the 2-week assessment point are also counted as having reached the primary endpoint.
Time frame: From start of radiotherapy to the 2-week assessment point (day 14 ± 3 days)
Time to Onset of Radiation-Induced Oral Mucositis
Time from the first day of radiotherapy to the first occurrence of any grade of RTOM, as assessed by WHO or RTOG criteria.
Time frame: From start of radiotherapy until 7 days after completion of radiotherapy, assessed up to 8 weeks (56 days) from start of radiotherapy.
Weekly Oropharyngeal Pain Score Measured by OMWQ
Change in oropharyngeal pain and functional impairment assessed weekly using the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN). The OMWQ-HN consists of 12 items assessing mouth and throat soreness, functional limitations, and pain. All item scores are linearly transformed to a 0 to 100 scale, with higher scores indicating worse symptoms and greater functional impairment.
Time frame: weekly from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first.
Weekly Body Weight Change During Radiotherapy
Weekly change in body weight (kg) from baseline. Weight is measured at baseline and then weekly throughout the radiotherapy course.
Time frame: weekly from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first.
Quality of Life (EORTC QLQ-H&N35)
Weekly change in quality of life scores using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-H\&N35). All scale scores range from 0 to 100, with higher scores indicating worse symptoms or lower quality of life. Assessments are performed weekly during the radiotherapy course and again at 4 weeks post-radiotherapy.
Time frame: weekly from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first.
Incidence of Intervention-Related Adverse Events
Proportion of participants experiencing at least one adverse event related to the study intervention, assessed using CTCAE version 5.0.
Time frame: From start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first.
Biomarker Discovery for RTOM Prediction
Collection of biological samples (blood, saliva, stool, urine) for exploratory analysis to identify and validate predictive biomarkers for radiation-induced oral mucositis.
Time frame: Baseline (prior to radiotherapy initiation), week 2 (± 2 days), and completion of radiotherapy (± 3 days).
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology →