Clinical trial NCT05318859: The Safety of Pharmacopuncture on Musculoskeletal Patients
Official title: The Safety Assessment of Pharmacopuncture on Musculoskeletal Patients: a Multi-center, Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Musculoskeletal Diseases or Conditions
Spine; Arthrosis
Keywords: Spinal joint
Safety
Pharmacopuncture
Adverse Event
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients with diagnosed spinal joint disease who are admitted or scheduled to be admitted to Jaseng Hospital of Korean Medicine, Bucheon Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean Medicine, or Haeundae Jaseng Hospital of Korean Medicine, Kyung Hee University Korean Medicine Hospital at Gangdong, Kyung Hee University Korean Medicine Hospital, Dongguk Traditional Herbal Medicine Clinic.

Brief summary: The purpose of this study is to evaluate the safety of pharmacopuncture by observing any adverse events that may occur after pharmacopuncture treatment in with spinal joint disease hospitalized patients at 7 Korean medicine hospitals and analyzing blood test results.

Detailed description: This study was an registry observational study, and was conducted in 7 Korean medicine hospitals (160 patients at Jaseng Korean medicine Hospital, 140 patients at Daejeon Jaseng Hospital of Korean Medicine, 140 patients at Bucheon Jaseng Hospital of Korean Medicine, 140 patients at Haeundae Jaseng Korean medicine Hospital, 140 patients at Kyunghee University of Korean medicine Hospital, 140 patients at Kyung Hee University of Korean Medicine Hospital at Gangdong, and 140 patients at Dongguk University Bundang Oriental Hospital).

Eligibility criteria: Inclusion Criteria:

* Inpatients with diagnosed spinal joint disease
* Patients who received pharmacopuncture treatment during hospitalization
* Patients who are 19 years of age or older and less than 70 years old
* Patients who agreed to participate in the clinical study and voluntarily given written informed consent

Exclusion Criteria:

* Patients with difficulty or refusal to give sign written informed consent
* Patients for whom the researchers judge participation in the clinical study to be difficult

Primary outcomes:
measure: Incidence of infection cases
timeFrame: 1 month
Secondary outcomes:
measure: Adverse events
timeFrame: during admission (from day 2 to until discharge), 1 month
measure: Number of abnormal cases that appeared on the blood analysis
timeFrame: Day 2, discharge day, 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
city: Bucheon
country: Korea, Republic of
facility: Bucheon Jaseng Hospital of Korean Medicine
state: Gyeonggi Province
city: Busan
country: Korea, Republic of
facility: Haeundae Jaseng Hospital of Korean Medicine
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Dongguk University Bundang Oriental Hospital
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, Ph.D.
role: STUDY_DIRECTOR
References: