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Psychological StressNCT06107777

The Effectiveness of Pharmacopuncture on Psychological Stress

A study testing Pharmacopuncture and Korean medical treatment in people with Psychological Stress, run by Jaseng Medical Foundation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 19 to 69 years
Conditions the study is for
Psychological Stress
What is being tested?
Pharmacopuncture and Korean medical treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSouth Korea
Study dates
20 Nov 2023to 26 Jun 2024
Phase
Interventional
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

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Jaseng Hospital of Korean Medicine

    Seoul, Gangnam-Gu, 135-896

Other trials in South Korea

About this study

Official title: The Efficacy of Pharmacopuncture on Inpatients With Psychological Stress Caused by Traffic Accidents: A Practical Randomized Control Pilot Study

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

Read the detailed description

"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.

This treatment is known to be an important part of Korean medicine treatment. However, there has been no specific value for the effect of this treatment.

Therefore, the investigators are going to conduct a practical randomized controlled trials to verify the efficacy and safety of Pharmacopuncture on Psychological Stress. From October 2023 to December 2024, the investigators are going to collect 50 inpatients who are suffering from Psychological Stress with the HADS-A(Hospital Anxiety and Depression Scale-anxiety) or HADS-D(Hospital Anxiety and Depression Scale-Depression) over 8 after injury by traffic accident(TA). For experimental group(n=25), the investigators will conduct Pharamacopuncture on 5 mandatory acupoints and 3 additional acupoints if needed durling the hospitalization and other Korean medical treatment. For control group(n=25), just Korean medical treatment except Pharamacopuncture on mandatory acupoints and additional acupoints will be conducted.

For these two groups, the investigators will compare Psychological stress intensity scale: Hospital Anxiety and Depression Scale (HADS), NRS of Anxiety, NRS of Depression, NRS of Physical pain, Sleeping disorder intensity scale: Korean version of the Insomnia Severity Index(ISI-K), subjective stress scale caused by traumatic events: Revised Version of the Impact of Event Scale of Korea(IES-R-K), EuroQol 5-Dimension (EQ-5D-5L) and Patient Global Impression of Change (PGIC)."

Being tested
Pharmacopuncture, Korean medical treatment
Keywords
Psychological Stress, Pharmacopuncture
Medical subject headings
Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PharmacopunctureProcedure or surgery

    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.

  • Korean medical treatmentProcedure or surgery

    acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Study groups in NCT06107777
Study groupRoleWhat they receive
Pharmacopucture on Acupoints Related to Psychological StressExperimentalThe 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.
Receives: Procedure: Pharmacopuncture; Procedure: Korean medical treatment
Korean medical treatmentActive comparatorThe control group will receive Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture(except on mandatory and additional acupoints) and Korean herbal medicine.
Receives: Procedure: Korean medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

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

    IES-R-K is the Korean version of impact of event scale revised. It was designed as a measure of post-traumatic stress disorder (PTSD) symptoms, and is a short, easily administered self-report questionnaire. It has 22 items and a cut-off score of 33 or above.

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

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

    ISI-K is a Korean version of Insomnia Severity Index. It was designed as a brief screening tool for insomnia and has the seven-item questionnaire asks respondents to rate the nature and symptoms of their sleep problems using a Likert-type scale.

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

  3. Numeric Rating Scale of Anxiety (NRS of Anxiety)

    NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their Anxiety using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

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

  4. Numeric Rating Scale of Depression(NRS of Depression)

    NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their Depression using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

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

  5. Numeric Rating Scale of Physical pain(NRS of Physical pain)

    NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their Physical pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

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

  6. EuroQol 5-Dimension (EQ-5D)

    The EQ-5D is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, the investigators will use the Korean version of the EQ-5D, which has been demonstrated to be valid.

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

  7. Patient Global Impression of Change (PGIC)

    The PGIC is an index that assesses improvements in functional limitation caused by whiplash injury. Participants rate the improvement in functional limitations after treatment on a 7-point Likert scale (1=Very much improved, 4=No change, 7=Very much worse). This index was originally developed for use in Psychology, but is currently used in various other medical fields to assess improvements in pain.

    Measured: Discharge 1 day, 15 days after admission day, 2 months after admission day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start20 Nov 2023
  3. Primary completion26 Jun 2024
  4. Study completion26 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06107777
Sponsor's protocol ID
JS-CT-2023-05
Status last verified
Mar 2024
First submitted
12 Oct 2023
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40995057

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacopuncture and Korean medical treatment in people with Psychological Stress, run by Jaseng Medical Foundation at 1 site 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 5 inclusion and 10 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Hospital Anxiety and Depression Scale(HADS) (time frame: Screeing day (day 1), Baseline (day2), Discharge 1 day, 15 days after admission day, 2 months after admission day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06107777, which also lists 1 linked publication.

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 6 Aug 2024.

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