The Effectiveness of Pharmacopuncture on Psychological Stress

NCT06107777 | Completed DMC

• 1 other identifier: JS-CT-2023-05
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a double blind, randomized controlled trail. Condition/disease: Psychological Stress treatment Intervention:Pharmacopuncture

Conditions

Psychological Stress

Keywords

Psychological Stress; Pharmacopuncture

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale(HADS)

  Hospital Anxiety and Depression Scale aims to measure symptoms of anxiety and depression. It is a self-rating scale developed to assess psychological distress in non-psychiatric patients. The HADS consists of 14 questions and each question is scored on a 4-point Likert scale(0=no problems, 3=severe problems) The odd numbers ask anxiety(HADS-A) and even number ask Depression(HADS-D). HADS-A (or HADS-D) cut-off score is 8 or above.

  Screeing day (day 1), Baseline (day2), Discharge 1 day, 15 days after admission day, 2 months after admission day

Secondary Outcomes (7)

• Korean version of the Insomnia Severity Index(IES-R-K)

  Baseline (day2), Discharge 1 day, 15 days after admission day, 2 months after admission day

• Korean version of the Insomnia Severity Index(ISI-K)

  Baseline (day2), Discharge 1 day, 15 days after admission day, 2 months after admission day

• Numeric Rating Scale of Anxiety (NRS of Anxiety)

  From baseline(Day2) up to Discharge 1 day, 15 days after admission day, 2 months after admission day

• Numeric Rating Scale of Depression(NRS of Depression)

  From baseline(Day2) up to Discharge 1 day, Discharge 1 day, 15 days after admission day, 2 months after admission day

• Numeric Rating Scale of Physical pain(NRS of Physical pain)

  From baseline(Day2) up to Discharge 1 day, Discharge 1 day, 15 days after admission day, 2 months after admission day

Study Arms (2)

Pharmacopucture on Acupoints Related to Psychological Stress

EXPERIMENTAL

The Pharmacopucture group will recieve Pharmacopucture treatment durling the hospitalization. The mandatory acupoints are (Dan-jung(CV17), Jung-wan(CV12), Gi-hae(CV6), Gwan-won(CV4), Sin-mun(HT7). If needed, they will recieve additional acupoints are (So-hae(HT3), Jung-jeo(TE3), Sam-eumgyo(SP6). A trained doctor of Korean medicine with at least 3 years of clinical experience are going to conduct the pharmacopucture. The Pharmacopucture group will also be treated with other Korean medical treatment everyday: acupuncture, chuna and Korean herbal medicine.

Procedure: Pharmacopuncture; Procedure: Korean medical treatment

Korean medical treatment

ACTIVE COMPARATOR

The control group will receive Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture(except on mandatory and additional acupoints) and Korean herbal medicine.

Procedure: Korean medical treatment

Interventions

Pharmacopuncture PROCEDURE

Pharmacopuncture is a treatment that combines 2 of the most frequented Korean medicine treatment methods - traditional acupuncture and herbal medicine - by injecting herbal medicine extract at acupoints.

Pharmacopucture on Acupoints Related to Psychological Stress

Korean medical treatment PROCEDURE

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Korean medical treatment; Pharmacopucture on Acupoints Related to Psychological Stress

Eligibility Criteria

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

You may qualify if:

• Patients aged 19-69 years on the date they sign the consent form.
• Patients who are suffered by Psychological Stress that occurred within 3 days after traffic accident.
• Patients who are hospitalized due to traffic accident.
• Patients with HADS-A ≥ 8 or HADS-D ≥ 8.
• Patients who provide consent to participate in the trial and return the informed consent form.

You may not qualify if:

• Patients with progressive neurological deficit or with serious neurological symptoms.
• Patients with a specific serious disease that may interfere with the interpretation of the therapeutic effects or results: malignancy, spondylitis, inflammatory spondylitis, etc.
• Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study.
• Patients with medical history of brain disease or surgery due to trauma.
• Patients who are addicted by drug or alcohol within the year.
• If acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease.
• Patients who are pregnant or planning to become pregnant
• Patients who are participated in clinical trials other than observational studies without therapeutic intervention.
• Patients who are difficult to complete the research participation agreement
• Other patients whose participation in the trial is judged by a researcher to be problematic

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Hospital of Korean Medicine

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

Location

Related Publications (1)

• Son JY, Jung S, Lee YH, Kim DG, Kim JW, Lee TJ, Cho SH, Ji JH, Cho HW, Kim SD, Lee YJ, Ha IH, Kim D, Shin BC. Pharmacopuncture for patients with psychological stress caused by traffic accidents: A pragmatic randomized controlled pilot trial. Integr Med Res. 2026 Mar;15(1):101251. doi: 10.1016/j.imr.2025.101251. Epub 2025 Sep 1.

  PMID: 40995057 DERIVED

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• In-Hyuk Ha, phD

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 30, 2023
• Study Start: November 20, 2023
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)