Integrated Traditional Chinese and Western Medicine to Care for the Late Stage of Mild to Moderate Burns and Scalds

NCT06424535 | Recruiting DMC

• 1 other identifier: CMUH113-REC1-055
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Burns and Scalds

Keywords

Acupuncture; Chinese medicine; Burns; Scalds; Low level laser

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)

Secondary Outcomes (4)

• Caloric intake per day

  At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)

• Daily fluid requirement (ml)

  At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)

• Daily urine output

  At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)

• Lund-Browder chart

  At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)

Study Arms (2)

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

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

Other: Western medicine

Interventions

Chinese medicine for internal or external use、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application of traditional Chinese herbal medicinal cake OTHER

The 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.

Also known as: Traditional Chinese medicine

intervention group

Western medicine OTHER

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.

Also known as: Routine Western medicine care

control group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age：20-90.
• Patients with mild to moderate injuries and burns that meet the American Burn Association (ABA) injury classification.

You may not qualify if:

• Patients refuse TCM intervention.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 403, Taiwan

RECRUITING

MeSH Terms

Conditions

Burns

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Central Study Contacts

Yu-Chen Lee, Ph.D.

CONTACT

886-4-22052121; 005167@tool.caaumed.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomized controlled crossover study

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 22, 2024
• Study Start: April 22, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

TW (1)