Therapeutic Effects of Traditional Chinese Medicine in Topical Use on Upper Extremities Fracture
Therapeutic Effects of Topical Herbal Medicine on Upper Extremities Fracture
1 other identifier
interventional
24
1 country
1
Brief Summary
There is no study evaluating the clinical effect of traditional chinese medicine(TCM) in topical use on musculotendinous injury, nor is that investigating the effectiveness on bone fracture healing. We hypothesize that with aid of topical chinese herbal medicine in addition to oral analgesics can be more beneficial in treating post traumatic injury, launching early mobilization, and enhancing fracture healing process.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2020
CompletedFirst Submitted
Initial submission to the registry
October 9, 2020
CompletedFirst Posted
Study publicly available on registry
October 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2023
CompletedNovember 27, 2024
November 1, 2024
2.6 years
October 9, 2020
November 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
reduction of pain
quantified by Visual Analogue Scale scoring system, Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain", providing a range of scores from 0-100 \[100-mm scale\]. A higher score indicates greater pain intensity.
1 week
swelling
recording circumference at the swelling site by tape measure
1 week
absence of adverse skin reaction to topical medicine
scored with Dyshidrotic Eczema Area and Severity Index (DASI index). The total score of the DASI results from the sum of severity grade score points of each of the four items (V = vesicles, E = erythema, S = desquamation, I = itch) multiplied by the affected area (A) score points: DASI = (pV + pE + pS + pI) Ă— pA. The maximum possible score is 60. By the DASI, the dyshidrotic eczema is graded as: mild (0-15), moderate (16-30) and severe (31-60).
1 week
Secondary Outcomes (2)
improvement of functional performances
1 week
recovery of bone alignment and union at the fracture site
1 week
Study Arms (4)
group A (Ru-Yih-Jin- Huang-Saan group)
ACTIVE COMPARATORHerbal medicine(Ru-Yih-Jin- Huang-Saan) will be applied to injured site and covered with gauze for 6 hours per day. Each subject will receive persistent treatment for 1 week
group B (Wan-Yin-Gao-Jia-Jean-Wey group)
EXPERIMENTALHerbal medicine (Wan-Yin-Gao-Jia-Jean-Wey) will be applied to injured site and covered with gauze for 6 hours per day. Each subject will receive persistent treatment for 1 week
placebo group( topical agent without therapeutic effects)
PLACEBO COMPARATORtopical agent without therapeutic effects will be applied to injured site and covered with gauze for 6 hours per day. Each subject will receive persistent treatment for 1 week
control group
NO INTERVENTIONonly oral analgesics will be applied to patients
Interventions
We conduct a clinical trial using topical herbal medicine, including Ru-Yih-Jin- Huang-Saan(RYJHS) and Wan-Yin-Gao-Jia-Jean-Wey (WYGJJW) in treating post fracture pain and tissue swell. 24 eligible participants diagnosed of upper limb fracture with soft tissue injury grading of C1, C0 from Tscherne classification transferred from Orthopedic outpatient clinic and inpatient will be enrolled and randomly allocated to 4 groups, including experimental group A (RYJHS group), group B (WYGJJW group), placebo group( topical agent without therapeutic effects), and control group (only oral analgesics group), with 6 participants in each group.
Eligibility Criteria
You may qualify if:
- Aged above 18 years with upper extremity fractures, including clavicle fractures, humerus fractures, forearm fractures, carpal bone fractures, finger fractures, etc.
- simple fractures with non-displacement or mild displacement, including transverse fracture, oblique fracture, linear fracture, impacted fracture, etc
- no need for surgery according to the orthopedist's evaluation
- willing to sign the informed consent of study and can cooperate with the doctor
- According to the orthopedist's evaluation, the soft tissue injury was grade C0 or C1 by Tscherne classification and without a high risk of infection
You may not qualify if:
- Compound fractures
- Simple fractures with moderate displacement or severe displacement
- The fracture pattern was a simple fracture but unstable, such as communicated fracture, etc.
- need for surgery according to the orthopedist's evaluation
- there were open wounds or at a high risk of infection
- According to the orthopedist's evaluation, the soft tissue was grade C2 or above by Tscherne classification and at a high risk of infection
- Unable to complete the questionnaire or cooperate with the doctor
- Allergy to Chinese herbal medicine patch or ointment
- Pregnancy
- heavy smoker
- Systemic diseases such as severe anemia, thyroid disease, uncontrolled diabetes mellitus, etc.
- Patients already on other treatment for upper extremity fractures, such as acupuncture therapy or transcutaneous electrical nerve stimulation
- Using other Chinese herbal medicine patch or ointment for treating upper extremity fractures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- YUAN-CHIEH YEHlead
Study Sites (1)
Keelung Chang Gung Memorial Hospital
Keelung, 20401, Taiwan
Related Publications (1)
Lin WY, Lu CA, Chang CW, Yeh YC. Therapeutic Effects of Topical Traditional Chinese Medicine on Upper Extremity Fractures. Int J Gen Med. 2025 Jun 9;18:2973-2988. doi: 10.2147/IJGM.S511294. eCollection 2025.
PMID: 40520457DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Deputy director of traditional chinese medicine department
Study Record Dates
First Submitted
October 9, 2020
First Posted
October 20, 2020
Study Start
September 23, 2020
Primary Completion
April 20, 2023
Study Completion
April 20, 2023
Last Updated
November 27, 2024
Record last verified: 2024-11