The Safety of Pharmacopuncture on Musculoskeletal Patients

September 1, 2025 updated by: In-Hyuk Ha, KMD, Jaseng Medical Foundation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Busan, South Korea
        • Haeundae Jaseng Hospital of Korean Medicine
      • Seoul, South Korea, 05278
        • Kyung Hee University Hospital at Gangdong
      • Seoul, South Korea, 02447
        • Kyung Hee University Korean Medicine Hospital
      • Seoul, South Korea, 13601
        • Dongguk University Bundang Oriental Hospital
    • Daejeon
      • Daejeon, Daejeon, South Korea, 35262
        • Daejeon Jaseng Hospital of Korean Medicine
    • Gangnam-Gu
      • Seoul, Gangnam-Gu, South Korea, 135-896
        • Jaseng Hospital of Korean Medicine
    • Gyeonggi Province
      • Bucheon-si, Gyeonggi Province, South Korea, 14598
        • Bucheon Jaseng Hospital of Korean Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of infection cases
Time Frame: 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.
1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaseng Medical Foundation

Investigators

  • Study Director: In-Hyuk Ha, Ph.D., Jaseng Medical Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2022

Primary Completion (Actual)

February 3, 2025

Study Completion (Actual)

February 3, 2025

Study Registration Dates

First Submitted

February 11, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (Actual)

April 8, 2022

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-CT-2021-17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Musculoskeletal Diseases or Conditions

Clinical Trials on Pharmacopuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe