The Safety of Pharmacopuncture on Musculoskeletal Patients

Jaseng Medical Foundation1,000 enrolled

Overview

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.

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

1,000

Conditions

Musculoskeletal Diseases or Conditions Spine; Arthrosis

Interventions

PharmacopunctureOTHER

Registry (observational study)

Eligibility

Sex: ALLMin age: 19 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (7)

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, Daejeon, South Korea

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, South Korea

Haeundae Jaseng Hospital of Korean Medicine

Busan, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 1 month

Secondary Outcomes

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.

Time frame: during admission (from day 2 to until discharge), 1 month

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.

Time frame: Day 2, discharge day, 1 month

Data from ClinicalTrials.gov

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