Evaluation of the Curative Effect of Ru-Yi-Jin-Huang-Saan

June 3, 2023 updated by: LienCheng Lin, Changhua Christian Hospital

Evaluation of the Efficacy of Ru-Yi-Jin-Huang-Saan on Colles' Fracture ---a Randomized, Double-blind, Placebo-controlled Trial

The purpose of this study is to assess the efficacy and safety of Ru-Yi-Jin-Huang-Saan for the treatment of Colles' fracture.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

According to the definition of the World Health Organization, Taiwan officially entered the aged society in 2018. The population over the age of 65 exceeds 14% of the total population. Based on this, it is estimated that we will enter a super-aged society in 2026. Because the older the age, the higher the rate of bone loss, and the higher the risk of osteoporosis, the easier it is to fracture due to falls. The incidence of bone fracture is directly proportional to the aging population. Traditional Chinese Medicine(TCM) interventional fracture treatment has a long history and experience.

Many recent studies show that TCM is benefit to reduce risk of total hip replacement and has a positive influence on the prevention of osteoporotic fracture. In drug mechanism research, some Chinese herbal medicine has been proved to promote bone fracture healing . Although most of these researches have been confirmed in the laboratory, little information is available on true patients. In clinical we observe a lot of topical Chinese medicine been used after fracture, so the purpose of this thesis is to investigate the effective of topical Chinese herbal paste. This study may lead to build the usage of guideline after fracture.

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact

Study Locations

  • Taiwan
      • Changhua, Taiwan, 50006
        • Recruiting
        • Changhua Christian Hospital
        • 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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. People who are over 20 years old and have no lack of mental ability can understand the content of the experiment and are willing to participate in it.
  2. Patients with Colles' fracture receive surgical fixation(ORIF).

Exclusion Criteria:

  1. People are unable to cooperate with experiments and fill out questionnaires.
  2. Patients have wounds on the back of their wrists.
  3. Patients are allergic to traditional Chinese medicine for external applications or have used other traditional Chinese medicine for external applications.
  4. Patients have cancer, stroke, and systemic diseases such as severe anemia, thyroid disease, uncontrolled diabetes, etc.
  5. Pregnant woman.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants received a starch patch topically twice daily for 6 days.
Drug: Placebo
Each patch contains 13g starch and 10c.c. water.
Other Names:
  • starch
Experimental: Ru-Yi-Jin-Huang-Saan
Participants received Ru-Yi-Jin-Huang-Saan patch topically twice daily for 6 days.
Drug: Ru Yi Jin Huang Powder
Each patch contains 13g Ru Yi Jin Huang Powder and 10c.c. water.
Other Names:
  • golden patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Patient-Rated Wrist Evaluation(PRWE) scale at Day 6
Time Frame: Baseline and Day 6

The PRWE scale is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.

  1. Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0.
  2. Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.

Possible scores range from 0 (best score) to 100 (worst score).

Change = (Day 6 score - Baseline score)
Baseline and Day 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in C-reactive protein(CRP) at Day 6
Time Frame: Baseline and Day 6

CRP is used primarily as an indicator of inflammation.The higher the value, the more severe the inflammation is.

Change = (Day 6 score - Baseline score)
Baseline and Day 6
Change from Baseline with ultrasound at Day 6
Time Frame: Baseline and Day 6

ultrasound is used primarily as an indicator of swelling.The larger the value, the more swollen it is.

Change = (Day 6 score - Baseline score)
Baseline and Day 6

Collaborators and Investigators

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

Sponsor

Changhua Christian Hospital

Investigators

  • Study Chair: LienCheng Lin, Master, Changhua Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

November 26, 2022

First Submitted That Met QC Criteria

November 26, 2022

First Posted (Actual)

December 6, 2022

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 3, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RYJHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Colles' Fracture

Clinical Trials on Ru Yi Jin Huang Powder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe