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Completed

NCT Number: NCT05318859

The Safety of Pharmacopuncture on Musculoskeletal Patients

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.

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Key information

Age range

19 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Daejeon Jaseng Hospital of Korean Medicine, Daejeon, South Korea

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacopuncture

Other

Registry (observational study)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2022
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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