Burns and ScaldsNCT06424535
Integrated Traditional Chinese and Western Medicine to Care for the Late Stage of Mild to Moderate Burns and Scalds
A study testing Chinese medicine for internal or external use、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application of traditional Chinese herbal medicinal cake and Western medicine in people with Burns and Scalds, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
To explore the effectiveness of TCM interventional treatment in shortening the recovery time and improving accompanying symptoms of burns and scalds. A single-center, randomized control crossover trial will compare TCM intervention to routine western medicine intervention. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Burns and Scalds
- What is being tested?
- Chinese medicine for internal or external use、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application of traditional Chinese herbal medicinal cake and Western medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 May 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age：20-90.
- Patients with mild to moderate injuries and burns that meet the American Burn Association (ABA) injury classification.
Who cannot join
- Patients refuse TCM intervention.
Trial locations and contacts
1 site in 1 country.
About this study
To explore the effectiveness of TCM interventional treatment in shortening the recovery time and improving accompanying symptoms of burns and scalds. A single-center, randomized control crossover trial will compare TCM intervention to routine western medicine intervention.
Read the detailed description
Burns are an irreversible traumatic injury. When the skin suffers severe burns, it will cause a systemic shock to the individual. Although in recent years, with the advancement of medical technology, the mortality rate from burns and scalds has dropped significantly compared with the past, patients with burns and scalds also face many challenges during the treatment process, including having to endure the pain of the wound and the risk of infection during hospitalization. During the rehabilitation period after discharge, scarring, limb contracture, skin itching and appearance changes caused by burns and scalds will cause a significant decline in the patient's quality of life and lead to depression, withdrawal, social isolation and other phenomena. Traditional Chinese medicine is based on empirical medicine and the observation records of doctors. It has been passed down from generation to generation, and also have experience in treating fever. There are external and internal treatments for treating burns and scalds. External medicinal powders and ointments, such as Sanhuang powder,Jinchuang ointment,Ziyun ointment, etc. For internal medicine,Huanglian Jiedu Decoction,Qingying Decoction,Xijiao Dihuang Decoction,Tuoli Disinfection Powder,Shenling Baizhu Powder, etc. can be used according to different syndrome types. In addition, past studies have also confirmed that acupuncture can relieve burns and scalds and inhibit scar formation. Acupuncture can also improve gastrointestinal function and can be used to maintain good nutrient absorption in patients during the treatment of burns and scalds.
There are few large-scale studies on the joint treatment of burns and scalds between Chinese and Western medicine. Therefore, the purpose of this project is to compare the wound healing status and healing time between two groups that simply received conventional Western medicine treatment and conventional treatment plus interventional treatment with Chinese medicine. The study investigate traditional Chinese medicine interventional treatment model for mild to moderate burns and scalds, and hope to implement it clinically in the future to improve medical quality and treatment efficiency.
A single-center, randomized control crossover trial. This study will be conducted at the Burn and Scald Center and Plastic Surgery/Traditional Chinese Medicine Clinic of China Medical University Hospital. When patients seek medical treatment for burns and scalds, they will be evaluated by a plastic surgeon and randomly assigned into two groups. One group will receive conventional Western medicine treatment plus TCM intervention. Different treatment strategies will be adopted depending on the severity of the condition, and the first assessment will be conducted before TCM interventional treatment. , a post-test was conducted four weeks after treatment. Afterward, the two groups will be alternated. The group that did not receive TCM intervention received TCM interventional treatment for four weeks, while the other group received only conventional Western medicine treatment. The assessment items included: assessment of wound and pain status. Pain status was assessed using the Visual Analogue Scale (VAS), and scars were assessed using the Vancouver Scar Scale (VSS). Assess, and record critical indicators according to clinical needs, such as caloric requirement (kcal), daily fluid requirement (ml), daily urine output (ml) and other physiological parameters, and record the burn area (Modified Lund-Browder chart) and depth. The control group will be treated with conventional Western medicine. Outcome measurements will be assessed at baseline, 4 weeks, and 4 weeks after crossover (8 weeks). The goal of our study is to measure the effectiveness of TCM interventional treatment in shortening recovery time and improving accompanying symptoms of burns and scalds.
- Conditions
- Burns and Scalds
- Being tested
- Chinese medicine for internal or external use、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application of traditional Chinese herbal medicinal cake, Western medicine
- Keywords
- Acupuncture, Chinese medicine, Burns, Scalds, Low level laser
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese medicine for internal or external use、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application of traditional Chinese herbal medicinal cakeOther
Also called Traditional Chinese medicine
The treatment project a Chinese medicine practitioner based individual needs of the patient, and will be followed by a four-week treatment.
- Traditional Chinese medicine for internal or external use: prescribe Chinese medicine based on syndrome differentiation and treatment of the patient's condition.
- Acupuncture or laser acupuncture treatment: Traditional Chinese medicine practitioners select acupuncture points to treat based on the patient's condition, and treat them twice a week for 20 minutes each time.
- Acupoint massage: Select treatment acupoints and techniques according to the patient's condition, 20 minutes at a time.
- Traditional Chinese Medicine Cake Acupoint Application: Warm Navel Cream to the CV-4 (Guanyuan) acupoint once a day
- Nursing and health education and guidance
- Dietary hygiene education: personalized western nutrition and TCM dietary guidance suggestions based on TCM constitution syndromes.
Western medicineOther
Also called Routine Western medicine care
Patients will receive routine Western medicine treatments as per individual patient's needs. The medications and bandages can vary due to the depth and size of the burn and scald.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 1. Traditional Chinese medicine for internal or external use
2. Acupuncture or laser acupuncture treatment
3. Acupoint massage
4. Traditional Chinese Medicine Cake Acupoint Application:
5. Nursing and health education and guidance
6. Dietary hygiene education Receives: Other: Chinese medicine for internal or external use、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application of traditional Chinese herbal medicinal cake |
| control group | Active comparator | Routine Western medicine burn and scald care prescribed by department doctor Receives: Other: Western medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Measured by the Visual Analogue Scale (VAS) 0-10: 0 =No Pain 2 = Mild 4 = Nagging 6 =Miserable 8 =Intense 10 = Worst
Measured: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
Vancouver Scar Scale
Scars measurement will be assessed using the Vancouver Scar Scale (VSS)Each characteristic is given a score, which are added together to give an overall score between 0 and 13. Higher score indicate wrost outcome.
Measured: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
Secondary outcomes (4)
Caloric intake per day
Amount of caloric (kcal) consumed per patient per day measured by department's nurse calculated by the amount of calories the patient consumed via feeding tube or oral feeding
Measured: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
Daily fluid requirement (ml)
Amount of daily fluid requirement (ml) per patient per day measured by department's nurse in milliliters (ml) of fluid intake and intravenous infusion or oral intake.
Measured: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
Daily urine output
Amount of Daily urine output measured by department's nurse in milliliters(ml) per patient patients Daily urine output measured by department's nurse in milliliters(ml) per day
Measured: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
Lund-Browder chart
burn area measured by Modified Lund-Browder chart, the score represents percentage (%) of the body cover by the burn along with body area, it score 0-100 and a higher score indicate worst outcome
Measured: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start16 May 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burns and ScaldsStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 1:1 randomized controlled crossover study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424535
- Sponsor's protocol ID
- CMUH113-REC1-055
- Status last verified
- Jun 2026
- First submitted
- 7 May 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Traditional Chinese and Western Medicine to Care for the Late Stage of Mild to Moderate Burns and Scalds
- ClinicalTrials.gov ID
- NCT06424535
- Acronym / sponsor ID
- CMUH113-REC1-055
- Conditions
- Burns and Scalds
- Keywords
- Acupuncture, Chinese medicine, Burns, Scalds, Low level laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the effectiveness of TCM interventional treatment in shortening the recovery time and improving accompanying symptoms of burns and scalds. A single-center, randomized control crossover trial will compare TCM intervention to routine western medicine intervention.
Detailed description
Burns are an irreversible traumatic injury. When the skin suffers severe burns, it will cause a systemic shock to the individual. Although in recent years, with the advancement of medical technology, the mortality rate from burns and scalds has dropped significantly compared with the past, patients with burns and scalds also face many challenges during the treatment process, including having to endure the pain of the wound and the risk of infection during hospitalization. During the rehabilitation period after discharge, scarring, limb contracture, skin itching and appearance changes caused by burns and scalds will cause a significant decline in the patient's quality of life and lead to depression, withdrawal, social isolation and other phenomena. Traditional Chinese medicine is based on empirical medicine and the observation records of doctors. It has been passed down from generation to generation, and also have experience in treating fever. There are external and internal treatments for treating burns and scalds. External medicinal powders and ointments, such as Sanhuang powder,Jinchuang ointment,Ziyun ointment, etc. For internal medicine,Huanglian Jiedu Decoction,Qingying Decoction,Xijiao Dihuang Decoction,Tuoli Disinfection Powder,Shenling Baizhu Powder, etc. can be used according to different syndrome types. In addition, past studies have also confirmed that acupuncture can relieve burns and scalds and inhibit scar formation. Acupuncture can also improve gastrointestinal function and can be used to maintain good nutrient absorption in patients during the treatment of burns and scalds.
There are few large-scale studies on the joint treatment of burns and scalds between Chinese and Western medicine. Therefore, the purpose of this project is to compare the wound healing status and healing time between two groups that simply received conventional Western medicine treatment and conventional treatment plus interventional treatment with Chinese medicine. The study investigate traditional Chinese medicine interventional treatment model for mild to moderate burns and scalds, and hope to implement it clinically in the future to improve medical quality and treatment efficiency.
A single-center, randomized control crossover trial. This study will be conducted at the Burn and Scald Center and Plastic Surgery/Traditional Chinese Medicine Clinic of China Medical University Hospital. When patients seek medical treatment for burns and scalds, they will be evaluated by a plastic surgeon and randomly assigned into two groups. One group will receive conventional Western medicine treatment plus TCM intervention. Different treatment strategies will be adopted depending on the severity of the condition, and the first assessment will be conducted before TCM interventional treatment. , a post-test was conducted four weeks after treatment. Afterward, the two groups will be alternated. The group that did not receive TCM intervention received TCM interventional treatment for four weeks, while the other group received only conventional Western medicine treatment. The assessment items included: assessment of wound and pain status. Pain status was assessed using the Visual Analogue Scale (VAS), and scars were assessed using the Vancouver Scar Scale (VSS). Assess, and record critical indicators according to clinical needs, such as caloric requirement (kcal), daily fluid requirement (ml), daily urine output (ml) and other physiological parameters, and record the burn area (Modified Lund-Browder chart) and depth. The control group will be treated with conventional Western medicine. Outcome measurements will be assessed at baseline, 4 weeks, and 4 weeks after crossover (8 weeks). The goal of our study is to measure the effectiveness of TCM interventional treatment in shortening recovery time and improving accompanying symptoms of burns and scalds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomized controlled crossover study
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Chinese medicine for internal or external use、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application of traditional Chinese herbal medicinal cake1. Traditional Chinese medicine for internal or external use 2. Acupuncture or laser acupuncture treatment 3. Acupoint massage 4. Traditional Chinese Medicine Cake Acupoint Application: 5. Nursing and health education and guidance 6. Dietary hygiene education |
| control group | Active comparator | Other: Western medicineRoutine Western medicine burn and scald care prescribed by department doctor |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age：20-90.
- Patients with mild to moderate injuries and burns that meet the American Burn Association (ABA) injury classification.
Key exclusion criteria (1 listed)
- Patients refuse TCM intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese medicine for internal or external use、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application of traditional Chinese herbal medicinal cakeAlso: Traditional Chinese medicineThe treatment project a Chinese medicine practitioner based individual needs of the patient, and will be followed by a four-week treatment. 1. Traditional Chinese medicine for internal or external use: prescribe Chinese medicine based on syndrome differentiation and treatment of the patient's condition. 2. Acupuncture or laser acupuncture treatment: Traditional Chinese medicine practitioners select acupuncture points to treat based on the patient's condition, and treat them twice a week for 20 minutes each time. 3. Acupoint massage: Select treatment acupoints and techniques according to the patient's condition, 20 minutes at a time. 4. Traditional Chinese Medicine Cake Acupoint Application: Warm Navel Cream to the CV-4 (Guanyuan) acupoint once a day 5. Nursing and health education and guidance 6. Dietary hygiene education: personalized western nutrition and TCM dietary guidance suggestions based on TCM constitution syndromes. | Other | intervention group |
| Western medicineAlso: Routine Western medicine carePatients will receive routine Western medicine treatments as per individual patient's needs. The medications and bandages can vary due to the depth and size of the burn and scald. | Other | control group |
Primary outcome
Visual Analogue Scale
Time frame: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
Measured by the Visual Analogue Scale (VAS) 0-10: 0 =No Pain 2 = Mild 4 = Nagging 6 =Miserable 8 =Intense 10 = Worst
Vancouver Scar Scale
Time frame: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
Scars measurement will be assessed using the Vancouver Scar Scale (VSS)Each characteristic is given a score, which are added together to give an overall score between 0 and 13. Higher score indicate wrost outcome.
4 secondary outcomes
Caloric intake per day
Time frame: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
Daily fluid requirement (ml)
Time frame: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
Daily urine output
Time frame: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
Lund-Browder chart
Time frame: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese medicine for internal or external use、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application of traditional Chinese herbal medicinal cake and Western medicine in people with Burns and Scalds, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.