The Safety of Pharmacopuncture on Musculoskeletal Patients

NCT05318859 | Completed

• 1 other identifier: JS-CT-2021-17
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 7

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.

Conditions

Musculoskeletal Diseases or Conditions; Spine; Arthrosis

Keywords

Spinal joint; Safety; Pharmacopuncture; Adverse Event

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adverse events

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

• Number of abnormal cases that appeared on the blood analysis

  Day 2, discharge day, 1 month

Interventions

Pharmacopuncture OTHER

Registry (observational study)

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (7)

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, Daejeon, 35262, South Korea

Location

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, 14598, South Korea

Location

Haeundae Jaseng Hospital of Korean Medicine

Busan, South Korea

Location

Kyung Hee University Korean Medicine Hospital

Seoul, 02447, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Dongguk University Bundang Oriental Hospital

Seoul, 13601, South Korea

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Rheumatic Diseases

Study Officials

• In-Hyuk Ha, Ph.D.

  Jaseng Medical Foundation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital director, Research director

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: April 8, 2022
• Study Start: April 27, 2022
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-09

Locations

KR (7)