Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 5:19 AM
Study NCT ID:
NCT05638360
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2022-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Curative Effect of Ru-Yi-Jin-Huang-Saan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003100', 'term': "Colles' Fracture"}], 'ancestors': [{'id': 'D000072039', 'term': 'Fracture Dislocation'}, {'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D011885', 'term': 'Radius Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013213', 'term': 'Starch'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-16', 'studyFirstSubmitDate': '2022-11-26', 'studyFirstSubmitQcDate': '2022-11-26', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Patient-Rated Wrist Evaluation(PRWE) scale at Day 6', 'timeFrame': 'Baseline and Day 6', 'description': 'The PRWE scale is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.\n\n1. 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.\n2. 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.\n\nPossible scores range from 0 (best score) to 100 (worst score).\n\nChange = (Day 6 score - Baseline score)'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in C-reactive protein(CRP) at Day 6', 'timeFrame': 'Baseline and Day 6', 'description': 'CRP is used primarily as an indicator of inflammation.The higher the value, the more severe the inflammation is.\n\nChange = (Day 6 score - Baseline score)'}, {'measure': 'Change from Baseline with ultrasound at Day 6', 'timeFrame': 'Baseline and Day 6', 'description': 'ultrasound is used primarily as an indicator of swelling.The larger the value, the more swollen it is.\n\nChange = (Day 6 score - Baseline score)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Colles' Fracture"]}, 'referencesModule': {'references': [{'pmid': '32186156', 'type': 'BACKGROUND', 'citation': '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': '20600749', 'type': 'BACKGROUND', 'citation': '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': '32469881', 'type': 'BACKGROUND', 'citation': "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': '16473730', 'type': 'BACKGROUND', 'citation': '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': '26516948', 'type': 'BACKGROUND', 'citation': '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': '22554658', 'type': 'BACKGROUND', 'citation': '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': '21288468', 'type': 'BACKGROUND', 'citation': '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': '35628978', 'type': 'BACKGROUND', 'citation': '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': '40053806', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the efficacy and safety of Ru-Yi-Jin-Huang-Saan for the treatment of Colles' fracture.", 'detailedDescription': '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.\n\nMany 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 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.\n2. Patients with Colles' fracture receive surgical fixation(ORIF).\n\nExclusion Criteria:\n\n1. People are unable to cooperate with experiments and fill out questionnaires.\n2. Patients have wounds on the back of their wrists.\n3. Patients are allergic to traditional Chinese medicine for external applications or have used other traditional Chinese medicine for external applications.\n4. Patients have cancer, stroke, and systemic diseases such as severe anemia, thyroid disease, uncontrolled diabetes, etc.\n5. Pregnant woman."}, 'identificationModule': {'nctId': 'NCT05638360', 'briefTitle': 'Evaluation of the Curative Effect of Ru-Yi-Jin-Huang-Saan', 'organization': {'class': 'OTHER', 'fullName': 'Changhua Christian Hospital'}, 'officialTitle': "Evaluation of the Efficacy of Ru-Yi-Jin-Huang-Saan on Colles' Fracture ---a Randomized, Double-blind, Placebo-controlled Trial", 'orgStudyIdInfo': {'id': 'RYJHS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ru-Yi-Jin-Huang-Saan', 'description': 'Participants received Ru-Yi-Jin-Huang-Saan patch topically twice daily for 6 days.', 'interventionNames': ['Drug: Ru Yi Jin Huang Powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received a starch patch topically twice daily for 6 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ru Yi Jin Huang Powder', 'type': 'DRUG', 'otherNames': ['golden patch'], 'description': 'Each patch contains 13g Ru Yi Jin Huang Powder and 10c.c. water.', 'armGroupLabels': ['Ru-Yi-Jin-Huang-Saan']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['starch'], 'description': 'Each patch contains 13g starch and 10c.c. water.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50006', 'city': 'Changhua', 'state': 'Changhua', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Lien-Cheng Lin, Master', 'role': 'CONTACT', 'email': 'shoklin@gmail.com'}], 'facility': 'Changhua Christian Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}], 'centralContacts': [{'name': 'LienCheng Lin, Master', 'role': 'CONTACT', 'email': 'shoklin@gmail.com', 'phone': '886-917603152'}], 'overallOfficials': [{'name': 'LienCheng Lin, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'Changhua Christian Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhua Christian Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of Department of Traditional Chinese Medicine', 'investigatorFullName': 'LienCheng Lin', 'investigatorAffiliation': 'Changhua Christian Hospital'}}}}