The Safety of Pharmacopuncture on Musculoskeletal Patients | NCT05318859

Studies
The Safety of Pharmacopuncture on Musculoskeletal Patients

NCT05318859

Sponsor

Jaseng Medical Foundation

Status

Completed

Last Update Posted

Sep 4, 2025Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Musculoskeletal Diseases or Conditions
Spine; Arthrosis

Interventions

Pharmacopuncture

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 27, 2022Actual

Primary Completion Date

Feb 3, 2025Actual

Completion Date

Feb 3, 2025Actual

First Submitted Date

Feb 11, 2022

First Submission Date that Met QC Criteria

Apr 1, 2022

First Posted Date

Apr 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2025

Last Update Posted Date

Sep 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

In-Hyuk Ha, KMD, Hospital director, Research director, Jaseng Medical FoundationPrincipal Investigator

Lead Sponsor

Jaseng Medical FoundationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Name	Type	Description	Arm Group Labels	Other Names
Pharmacopuncture	Other	Registry (observational study)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	during admission (from day 2 to until discharge), 1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

69 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
In-Hyuk Ha, Ph.D.	Jaseng Medical Foundation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Daejeon Jaseng Hospital of Korean Medicine		Daejeon	Daejeon	35262	South Korea
Jaseng Hospital of Korean Medicine

Condition Browse Module

MeSH Terms

ID	Term
D009140	Musculoskeletal Diseases
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D012216	Rheumatic Diseases

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