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NCT Number: NCT05638360

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

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

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Key information

Conditions

Colles' Fracture Fracture Dislocation Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Radius Fractures Wounds and Injuries

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Changhua Christian Hospital

Changhua, 50006, Taiwan

Location status: Recruiting

Location contact

Lien-Cheng Lin, Master

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients with Colles' fracture receive surgical fixation(ORIF).

Exclusion criteria

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

Treatment and study plan

Ru Yi Jin Huang Powder

Drug

Each patch contains 13g Ru Yi Jin Huang Powder and 10c.c. water.

Other names: golden patch

Placebo

Drug

Each patch contains 13g starch and 10c.c. water.

Other names: starch

Primary outcomes

  1. 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.

    • 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.
    • 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)

Secondary outcomes

  1. 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)

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

LienCheng Lin, Master

CONTACT

[email protected]

886-917603152

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2022
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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