The Safety of Pharmacopuncture on Musculoskeletal Patients

Recruiting

• Conditions: Spine; Arthrosis; Musculoskeletal Diseases or Conditions

• Registration Number: NCT05318859
• Lead Sponsor: Jaseng Medical Foundation

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).

Study Timeline

• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-04-01
• Study First Posted: 2022-04-08
• Study Start: 2022-04-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-05-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of infection cases	1 month	Infection is one of the representative adverse events for subcutaneous and intramuscular interventions. Infection cases will be collected to evaluate the safety of pharmacopuncture.

Secondary Outcome Measures

Name	Time	Method
Number of abnormal cases that appeared on the blood analysis	Day 2, discharge day, 1 month	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.
Adverse events	during admission (from day 2 to until discharge), 1 month	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.

Trial Locations

Locations (7)

Jaseng Hospital of Korean Medicine; 🇰🇷 Seoul, Gangnam-Gu, 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

Kyung Hee University Korean Medicine Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of

Dongguk University Bundang Oriental Hospital; 🇰🇷 Seoul, Korea, Republic of