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

Changhua Christian Medical Foundation

Status and phase: Enrolling; Phase 2

Conditions: Colles' Fracture

Treatments: Drug: Ru Yi Jin Huang Powder; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05638360

RYJHS

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Ru-Yi-Jin-Huang-Saan

Experimental group

Description:

Participants received Ru-Yi-Jin-Huang-Saan patch topically twice daily for 6 days.

Treatment:

Drug: Ru Yi Jin Huang Powder

Placebo

Placebo Comparator group

Description:

Participants received a starch patch topically twice daily for 6 days.

Treatment:

Drug: Placebo