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NCT05318859 Clinical Trial

The Safety of Pharmacopuncture on Musculoskeletal Patients

Musculoskeletal Diseases or Conditions Clinical Trial

Official title:
The Safety Assessment of Pharmacopuncture on Musculoskeletal Patients: a Multi-center, Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05318859
Other study ID # JS-CT-2021-17
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 27, 2022
Est. completion date December 31, 2025

Study information
Verified date June 2023
Source Jaseng Medical Foundation
Contact In-Hyuk Ha, Ph.D.
Phone 82-2-2222-2740
Email hanihata@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 31, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years to 69 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Pharmacopuncture
Registry (observational study)

Locations
Country Name City State
Korea, Republic of Bucheon Jaseng Hospital of Korean Medicine Bucheon Gyeonggi Province
Korea, Republic of Haeundae Jaseng Hospital of Korean Medicine Busan
Korea, Republic of Daejeon Jaseng Hospital of Korean Medicine Daejeon
Korea, Republic of Dongguk University Bundang Oriental Hospital Seoul
Korea, Republic of Jaseng Hospital of Korean Medicine Seoul Gangnam-Gu
Korea, Republic of Kyung Hee University Hospital at Gangdong Seoul
Korea, Republic of Kyung Hee University Korean Medicine Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of infection cases Infection is one of the representative adverse events for subcutaneous and intramuscular interventions. Infection cases will be collected to evaluate the safety of pharmacopuncture. 1 month
Secondary Adverse events Adverse events refers to undesirable and unintended signs (eg, abnormalities in laboratory test values), symptoms, or diseases that appear after a procedure in the course of a clinical study. Any reported adverse events will be collected to evaluate the safety of pharmacopuncture. during admission (from day 2 to until discharge), 1 month
Secondary Number of abnormal cases that appeared on the blood analysis Any blood analysis result including liver function and renal function will be measured at admission day and discharge moment. The researcher records every abnormal result cases that appeared on the blood analysis and number of abnormal cases will be counted, to evaluate the safety of pharmacopuncture. Day 2, discharge day, 1 month
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