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

Primary Purpose

Bone Fractures, Traditional Chinese Medicine, Chinese Herbal Medicine

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Ru-Yih-Jin- Huang-Saan(RYJHS), Wan-Yin-Gao-Jia-Jean-Wey(WYGJJW), placebo ( topical agent without therapeutic effects)
Sponsored by
YUAN-CHIEH YEH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Fractures focused on measuring Wan Yin Gao, Chinese herbal patch, Upper Extremity fracture, Ru Yih Jin Huang Saan, Chinese herbal ointment, Wan Yin Gao Jia Jean Wey, Upper Extremities Fracture, Traditional Chinese Medicine, Chinese herbal medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keelung Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Placebo Comparator

No Intervention

Arm Label

group A (Ru-Yih-Jin- Huang-Saan group)

group B (Wan-Yin-Gao-Jia-Jean-Wey group)

placebo group( topical agent without therapeutic effects)

control group

Arm Description

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

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

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

only oral analgesics will be applied to patients

Outcomes

Primary Outcome Measures

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.
swelling
recording circumference at the swelling site by tape measure
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) × 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).

Secondary Outcome Measures

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

Full Information

First Posted
October 9, 2020
Last Updated
October 18, 2020
Sponsor
YUAN-CHIEH YEH
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1. Study Identification

Unique Protocol Identification Number
NCT04593849
Brief Title
Therapeutic Effects of Traditional Chinese Medicine in Topical Use on Upper Extremities Fracture
Official Title
Therapeutic Effects of Topical Herbal Medicine on Upper Extremities Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
September 21, 2021 (Anticipated)
Study Completion Date
September 21, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
YUAN-CHIEH YEH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Fractures, Traditional Chinese Medicine, Chinese Herbal Medicine
Keywords
Wan Yin Gao, Chinese herbal patch, Upper Extremity fracture, Ru Yih Jin Huang Saan, Chinese herbal ointment, Wan Yin Gao Jia Jean Wey, Upper Extremities Fracture, Traditional Chinese Medicine, Chinese herbal medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A (Ru-Yih-Jin- Huang-Saan group)
Arm Type
Active Comparator
Arm Description
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
Arm Title
group B (Wan-Yin-Gao-Jia-Jean-Wey group)
Arm Type
Experimental
Arm Description
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
Arm Title
placebo group( topical agent without therapeutic effects)
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
control group
Arm Type
No Intervention
Arm Description
only oral analgesics will be applied to patients
Intervention Type
Other
Intervention Name(s)
Ru-Yih-Jin- Huang-Saan(RYJHS), Wan-Yin-Gao-Jia-Jean-Wey(WYGJJW), placebo ( topical agent without therapeutic effects)
Intervention Description
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.
Primary Outcome Measure Information:
Title
reduction of pain
Description
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.
Time Frame
1 week
Title
swelling
Description
recording circumference at the swelling site by tape measure
Time Frame
1 week
Title
absence of adverse skin reaction to topical medicine
Description
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).
Time Frame
1 week
Secondary Outcome Measure Information:
Title
improvement of functional performances
Description
calculated by The Disabilities of the Arm, Shoulder and Hand Score (QuickDash), ranging from 0 (no disability) to 100 (most severe disability)
Time Frame
1 week
Title
recovery of bone alignment and union at the fracture site
Description
validated with radiographic images
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Keelung Chang Gung Memorial Hospital
City
Keelung
ZIP/Postal Code
20401
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YUAN-CHIEH YEH, Doctor
Phone
(02) 24313131
Ext
2127
Email
b9005030@gmail.com
First Name & Middle Initial & Last Name & Degree
WAN-YI LIN, Doctor
Phone
(02) 24313131
Ext
2127
Email
wisamur@gmail.com

12. IPD Sharing Statement

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

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