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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Ru Yi Jin Huang Powder
  Each patch contains 13g Ru Yi Jin Huang Powder and 10c.c. water.
• Препарат Placebo
  Each patch contains 13g starch and 10c.c. water.

Первичные конечные точки

• Change from Baseline in Patient-Rated Wrist Evaluation(PRWE) scale at Day 6 [Срок оценки: Baseline and Day 6]

Вторичные конечные точки (2)

• Change from Baseline in C-reactive protein(CRP) at Day 6 [Срок оценки: Baseline and Day 6]
• Change from Baseline with ultrasound at Day 6 [Срок оценки: Baseline and Day 6]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Changhua Christian Hospital — Changhua

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 35628978

Идентификаторы

NCT: NCT05638360 · RYJHS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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