Therapeutic Effects of Traditional Chinese Medicine in Topical Use on Upper Extremities Fracture

October 18, 2020 updated by: YUAN-CHIEH YEH

Therapeutic Effects of Topical Herbal Medicine on Upper Extremities Fracture

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Orthopedic fractures are a common acute health issue, which often accompanied with life-long burden, accounts up to 34% total lifetime medical costs in the United States. It may also lead to significant long-term morbidity and, potentially, mortality if treated Improperly. Initial management is particularly crucial in helping the bone fracture healing process and reducing comorbidity. Apart from fracture fixation through nonoperative/conservative or operative methods in aim to restore anatomic alignment, oral analgesics are same important in Orthopedics patients in symptomatic control and for early mobilization. Non-opioid medication such as Acetaminophen or NSAIDs are routinely used for injury or postoperative pain management, despite that inevitable side effects including gastrointestinal bleeding and inconsistent show concerns of NSAIDs impairing bone healing in historical animal-based studies.

In which case, topical agents used in traditional chinese medicine(TCM) usually become a well-placed supplement to relieve inflammatory conditions. In spite of the lack of scientific evidence of efficacy, topical applications such as Ru- Yih-Jin-Huang-Saan (RYJHS) and Wan-Yin-Gao(WYG) have been used on musculoskeletal injuries in oriented countries for centuries, as their transcutaneous transport of the herbal chemicals to deeper tissues show biological activities of anti-inflammation, reducing swelling soft tissue, angiogenesis, fracture healing and cellular proliferation.

To date, there is no study evaluating the clinical effect of traditional chinese medicine 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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Keelung, Taiwan, 20401
        • Recruiting
        • Keelung Chang Gung Memorial Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A (Ru-Yih-Jin- Huang-Saan group)
Herbal 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
Other: Ru-Yih-Jin- Huang-Saan(RYJHS), Wan-Yin-Gao-Jia-Jean-Wey(WYGJJW), placebo ( topical agent without therapeutic effects)
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.
Experimental: group B (Wan-Yin-Gao-Jia-Jean-Wey group)
Herbal 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
Other: Ru-Yih-Jin- Huang-Saan(RYJHS), Wan-Yin-Gao-Jia-Jean-Wey(WYGJJW), placebo ( topical agent without therapeutic effects)
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.
Placebo Comparator: placebo group( topical agent without therapeutic effects)
topical 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
Other: Ru-Yih-Jin- Huang-Saan(RYJHS), Wan-Yin-Gao-Jia-Jean-Wey(WYGJJW), placebo ( topical agent without therapeutic effects)
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.
No Intervention: control group
only oral analgesics will be applied to patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of pain
Time Frame: 1 week
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
Time Frame: 1 week
recording circumference at the swelling site by tape measure
1 week
absence of adverse skin reaction to topical medicine
Time Frame: 1 week

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) × 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement of functional performances
Time Frame: 1 week
calculated by The Disabilities of the Arm, Shoulder and Hand Score (QuickDash), ranging from 0 (no disability) to 100 (most severe disability)
1 week
recovery of bone alignment and union at the fracture site
Time Frame: 1 week
validated with radiographic images
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

YUAN-CHIEH YEH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2020

Primary Completion (Anticipated)

September 21, 2021

Study Completion (Anticipated)

September 21, 2022

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

October 18, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 18, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202001174A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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