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Colles' FracturePhase 2NCT05638360

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

A Phase 2 study testing Ru Yi Jin Huang Powder in people with Colles' Fracture, run by Changhua Christian Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Colles' Fracture
What is being tested?
Ru Yi Jin Huang Powder
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteTaiwan
Study dates
1 May 2023to 30 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

LienCheng Lin, Master contact

886-917603152

shoklin@gmail.com

Taiwan1 site, 1 recruiting

  • Changhua Christian Hospital

    Changhua, Changhua, 50006

    Lien-Cheng Lin, Master, shoklin@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Ru Yi Jin Huang Powder, Placebo
Medical subject headings
Colles' Fracture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ru Yi Jin Huang PowderDrug

    Also called golden patch

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

  • PlaceboDrug

    Also called starch

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

Study groups in NCT05638360
Study groupRoleWhat they receive
Ru-Yi-Jin-Huang-SaanExperimentalParticipants received Ru-Yi-Jin-Huang-Saan patch topically twice daily for 6 days.
Receives: Drug: Ru Yi Jin Huang Powder
PlaceboPlacebo comparatorParticipants received a starch patch topically twice daily for 6 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Patient-Rated Wrist Evaluation(PRWE) scale at 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)

    Measured: Baseline and Day 6

Secondary outcomes (2)

  1. Change from Baseline in C-reactive protein(CRP) at 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)

    Measured: Baseline and Day 6

  2. Change from Baseline with ultrasound at 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)

    Measured: Baseline and Day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2022
  2. Study start1 May 2023
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05638360
Sponsor's protocol ID
RYJHS
Status last verified
Aug 2024
First submitted
26 Nov 2022
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Siu WS, Shiu HT, Shum WT, Ko Chun H, Lau CBS, Hung Leung K, Leung Ping C. Chinese topical herbal medicine gives additive effect on pharmaceutical agent on fracture healing. J Tradit Chin Med. 2019 Dec;39(6):853-860.

    PubMed 32186156

  • Peng LH, Ko CH, Siu SW, Koon CM, Yue GL, Cheng WH, Lau TW, Han QB, Ng KM, Fung KP, Lau CB, Leung PC. In vitro & in vivo assessment of a herbal formula used topically for bone fracture treatment. J Ethnopharmacol. 2010 Sep 15;131(2):282-9. doi: 10.1016/j.jep.2010.06.039. Epub 2010 Jun 30.

    PubMed 20600749

  • Raittio L, Launonen AP, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Laitinen MK, Mattila VM. Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial. PLoS One. 2020 May 29;15(5):e0232153. doi: 10.1371/journal.pone.0232153. eCollection 2020.

    PubMed 32469881

  • Wah JW, Wang MK, Ping CL. Construct validity of the Chinese version of the Patient-rated Wrist Evaluation Questionnaire (PRWE-Hong Kong Version). J Hand Ther. 2006 Jan-Mar;19(1):18-26, quiz 27. doi: 10.1197/j.jht.2005.10.003.

    PubMed 16473730

  • Neumaier M, Braun KF, Sandmann G, Siebenlist S. C-Reactive Protein in Orthopaedic Surgery. Acta Chir Orthop Traumatol Cech. 2015;82(5):327-31.

    PubMed 26516948

  • Sebastin SJ, Chung KC. An Asian perspective on the management of distal radius fractures. Hand Clin. 2012 May;28(2):151-6. doi: 10.1016/j.hcl.2012.03.007.

    PubMed 22554658

  • Yang NP, Chan CL, Yu IL, Lee CY, Chou P. Estimated prevalence of orthopaedic fractures in Taiwan--A cross-sectional study based on nationwide insurance data. Injury. 2010 Dec;41(12):1266-72. doi: 10.1016/j.injury.2010.05.025. Epub 2010 Jun 17.

    PubMed 21288468

  • Raudasoja L, Aspinen S, Vastamaki H, Ryhanen J, Hulkkonen S. Epidemiology and Treatment of Distal Radius Fractures in Finland-A Nationwide Register Study. J Clin Med. 2022 May 18;11(10):2851. doi: 10.3390/jcm11102851.

    PubMed 35628978

  • Lin LC, Wang WH, Chang WK, Gao JL, Yang RC, Hsu PC, Lo LC. Evaluation of the Efficacy of the Traditional Chinese Medicine Formulation Ru-Yi-Jin-Huang-Saan on Colles Fracture After Surgery: Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial. JMIR Res Protoc. 2025 Mar 5;14:e56849. doi: 10.2196/56849.

    PubMed 40053806

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ru Yi Jin Huang Powder in people with Colles' Fracture, run by Changhua Christian Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact LienCheng Lin, Master (886-917603152, shoklin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Patient-Rated Wrist Evaluation(PRWE) scale at Day 6 (time frame: Baseline and Day 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05638360, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.

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