Musculoskeletal Diseases or ConditionsNCT05318859
The Safety of Pharmacopuncture on Musculoskeletal Patients
An observational study of Musculoskeletal Diseases or Conditions and Spine; Arthrosis, run by Jaseng Medical Foundation at 7 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Musculoskeletal Diseases or Conditions, Spine; Arthrosis
- What is being tested?
- Pharmacopuncture
- How many people
- 1,000 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 27 Apr 2022to 3 Feb 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi Province, 14598
Haeundae Jaseng Hospital of Korean Medicine
Busan
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, Daejeon, 35262
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
Kyung Hee University Korean Medicine Hospital
Seoul, 02447
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Dongguk University Bundang Oriental Hospital
Seoul, 13601
About this study
Official title: 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.
Read the 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).
- Being tested
- Pharmacopuncture
- Keywords
- Spinal joint, Safety, Pharmacopuncture, Adverse Event
- Medical subject headings
- Musculoskeletal Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmacopunctureOther
Registry (observational study)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day 2, discharge day, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start27 Apr 2022
- Primary completion3 Feb 2025
- Study completion3 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal Diseases or ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, Ph.D., Study director, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318859
- Sponsor's protocol ID
- JS-CT-2021-17
- Status last verified
- Sep 2025
- First submitted
- 11 Feb 2022
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety Assessment of Pharmacopuncture on Musculoskeletal Patients: a Multi-center, Registry
- ClinicalTrials.gov ID
- NCT05318859
- Acronym / sponsor ID
- JS-CT-2021-17
- Keywords
- Spinal joint, Safety, Pharmacopuncture, Adverse Event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PharmacopunctureRegistry (observational study) | Other | – |
Primary outcome
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.
2 secondary outcomes
Adverse events
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Hyuk Ha, Ph.D. study director
Jaseng Medical Foundation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Diseases or Conditions and Spine; Arthrosis, run by Jaseng Medical Foundation at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infection cases (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.