Health TrialsbyHealthPanel

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

ConditionColles' Fracture
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-80
SponsorChanghua Christian Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ru Yi Jin Huang Powder

    Drug

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

  • Placebo

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Ru-Yi-Jin-Huang-SaanExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame
Baseline and Day 6

Secondary outcomes

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)

Time frame
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)

Time frame
Baseline and Day 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changhua Christian Hospital

Lead sponsor

Source ClinicalTrials.gov
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