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Temporomandibular DisorderNCT04087005

Efficacy and Safety of JHG002 for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial

A study testing hominis placental pharmacopuncture in people with Temporomandibular Disorder, run by Jaseng Medical Foundation at 2 sites 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 2-arm parallel, assessor blinded, multi-centre, randomised controlled trial. Read more about this study

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Temporomandibular Disorder
What is being tested?
hominis placental pharmacopuncture
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
2 sitesSouth Korea
Study dates
17 Oct 2019to 21 Jul 2020
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with unilateral or bilateral TMJ pain
  • Patients with VAS≥40mm for the area showing TMJ pain (for patients with bilateral pain, the side with worse pain)
  • Patients complaining of persistent of sporadic TMJ pain for at least 3 months
  • Patients diagnosed as myofascial TMD (Axis I: Group 1) based on the RDC/TMD diagnostic criteria[5]
  • Patients aged 19-70 years on the date they sign the consent form
  • Patients who provide consent to participate in the trial and return the informed consent form

Who cannot join

  • Patients whose current pain episode developed or worsened because of a road traffic accident or traumatic injury
  • Patients diagnosed in Group 2 or 3 of Axis I based on the RDC/TMD diagnostic criteria
  • Patients who have undergone surgery related to the TMJ
  • Patients with other chronic disease that could interfere with interpretation of the treatment effects or outcomes (e.g., rheumatoid arthritis, neoplastic disease, stroke, or myocardial infarction)
  • Patients currently taking steroids, immunosuppressants, psychiatric drugs, or other drugs that could affect the study results
  • Patients who have received HPP within the last month, or who have taken drugs that could affect pain, such as NSAIDs, within the last week
Show all 17Show fewer
  • Pregnant or breastfeeding women
  • Patients who have finished participation in another clinical trial within the last month, who participated in another trial within 6 months of selection, or who are planning to participate in another clinical trial during the follow-up period
  • Patients with a history of hypersensitivity after HPP
  • Diabetic patients with uncontrolled blood glucose (fasting blood glucose ≥180mg/dl)
  • Patients with AST (GOT) or ALT (GPT) at least 2 times the normal range at the testing centre
  • Patients with creatinine at least 2 times the normal range at the testing centre
  • Patients suspected to have organic disease
  • Patients with cardiac, hepatic, renal, or other serious complications
  • Patients with psychogenic disease
  • Patients who are unable to receive pharmacopuncture due to e.g., inflammation or a wound at the relevant acupoints
  • Other patients whose participation in the trial is judged by a researcher to be problematic

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Jaseng Hospital of Korean Medicine

    Seoul, Gangnam-Gu, 135-896

  • Kyung Hee University Hospital at Gangdong

    Seoul

Other trials in South Korea

About this study

Official title: Efficacy and Safety of JHG002(Hominis Placenta, 紫河車) Therapy for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial)

This study is a 2-arm parallel, assessor blinded, multi-centre, randomised controlled trial.

Read the detailed description

From 2 hospitals of Korean medicine, we will enrol 82 chronic TMD patients in Axis 1, Group Ⅰ according to RDC/TMD diagnostic criteria, and randomly allocate 41 patients each to an HPP group and a physical therapy (PT) group. Treatment will be administered in 10 rounds, after which there will be 4 follow-up visits (6, 9, 13, and 25 weeks from baseline). The primary end point is 6 weeks after baseline, and the primary outcome is the difference in Visual analogue scale (VAS) score for temporomandibular pain between baseline and Week 6. Secondary outcomes will be Numeric rating scale (NRS) scores for temporomandibular pain and discomfort, temporomandibular joint range of motion, Korean version of Beck's Depression Index-Ⅱ(K-BDI-II), Jaw Functional Limitation Scale (JFLS), Patien Global Impression of Change(PGIC), and quality of life. Using data on adverse events and cost-effectiveness in the two groups, we will perform a safety assessment and a cost-effectiveness analysis (economic assessment).

Being tested
hominis placental pharmacopuncture
Medical subject headings
Temporomandibular Joint Disorders

What participants receive

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

  • hominis placental pharmacopunctureOther

    Hominis placental pharmacopuncture is human placental extract, which has been used in traditional Korean medicine to treat chronic diseases, including frailty, cough, anorexia, and fatigue, by enhancing the body's resistance.

Study groups in NCT04087005
Study groupRoleWhat they receive
Hominis placental pharmacopunctureExperimentalThe Hominis placental pharmacopuncture group will receive 10 sessions of Hominis placental pharmacopuncture at 2 sessions/week for 5 weeks. A trained doctor of Korean medicine with at least 2 years clinical experience will administer JHG002 pharmacopuncture with a disposable syringe (0.5ml) directly into the designated sites, using a standardized method.
Receives: Other: hominis placental pharmacopuncture
Transcutaneous electrical nerve stimulationActive comparatorThe control group will receive 2 sessions/week of TENS for 5 weeks. A high-frequency, low-intensity stimulus of 50-100Hz and up to 15mA will be used, such that the patients feel a current but do not feel pain. At each treatment visit, a physiotherapist will administer the treatment to the bilateral temporomandibular joint for 15 minutes. Both centres will use the same TENS device-a BioTron-DX (D.M.C, Osan, South Korea).
Receives: Other: hominis placental pharmacopuncture

What is being measured

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

  1. The difference in visual analogue scale (VAS) of temporomandibular pain

    The primary outcome is the difference in VAS for TMJ pain between baseline and the primary end point (Week 6). VAS is an assessment index in which the patient records their pain on a 100mm line from 'no pain' at one end, and 'the most severe pain imaginable' at the other end.

    Measured: Week 6

Secondary outcomes (7)

  1. Numeric rating scale (NRS) of TMJ pain and discomfort

    The extent of TMJ pain and discomfort in the last week will be assessed using NRS. 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 TMJ pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

    Measured: Week 6

  2. TMJ range of motion

    A Therabite Range of Motion Ruler will be used to measure the range of TMJ mouth opening and excursive movement; the measurement method will follow the guidelines provided by the International RDC/TMD Consortium.

    Measured: Week 6

  3. Korean version of Beck's Depression Index-Ⅱ (K-BDI-Ⅱ)

    The BDI-Ⅱ is an index for diagnosing depression, consisting of 21 questions related to sadness, guilt, suicidal ideation, and loss of interest. In this study, we will use the K-BDI-II, which has been demonstrated to be valid and reliable by a Korean research group.

    Measured: Week 6

  4. Jaw Functional Limitation Scale (JFLS)

    The JFLS is an index assessing jaw function (mastication, mobility, and emotional and verbal expression) in the last month. The instrument consists of 20 questions, and each question is scored 0-10, where 0 points is 'no impairment' and 10 points is 'very severe impairment'. In this study, we will use the official Korean version of the 20-question JFLS, which has been demonstrated to be reliable.

    Measured: Week 6

  5. Patient Global Impression of Change (PGIC)

    The PGIC is an index that assesses improvements in functional limitation caused by TMD in 7 grades. 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: Week 6

  6. The five level version of EuroQol-5 Dimension (EQ-5D-5L)

    The EQ-5D-5L 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-5L 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, we will use the Korean version of the EQ-5D-5L, which has been demonstrated to be valid.

    Measured: Week 6

  7. SF-12

    The SF-12 is a shortened version of the Short Form-36 Health Survey (SF-36), which is a widely used instrument to assess health-related quality of life. The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life. In this study, we will use the Korean version of the SF-12, which has been demonstrated to be reliable and valid.

    Measured: Week 6

Timeline

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

  1. First posted12 Sep 2019
  2. Study start17 Oct 2019
  3. Primary completion21 Jul 2020
  4. Study completion21 Jul 2020

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
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04087005
Sponsor's protocol ID
JS-CT-2017-04
Status last verified
May 2021
First submitted
11 Sep 2019
Last updated
2 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim D, Kim ES, Kim KW, Cho JH, Lee YJ, Ha IH. Cost-Effectiveness of Hominis Placenta Therapy for Chronic Temporomandibular Disorder: An Economic Evaluation Alongside a Pragmatic Randomised Controlled Trial. J Oral Rehabil. 2025 Jun;52(6):807-816. doi: 10.1111/joor.13932. Epub 2025 Feb 3.

    PubMed 39895393

  • Park KS, Kim ES, Kim KW, Cho JH, Lee YJ, Lee J, Ha IH. Effectiveness and safety of hominis placental pharmacopuncture for chronic temporomandibular disorder: A multi-center randomized controlled trial. Integr Med Res. 2024 Jun;13(2):101044. doi: 10.1016/j.imr.2024.101044. Epub 2024 Apr 20.

    PubMed 38779539

  • Kim J, Park KS, Lee YJ, Kim KW, Cho JH, Ha IH. Efficacy, safety, and economic assessment of hominis placental pharmacopuncture for chronic temporomandibular disorder: a protocol for a multicentre randomised controlled trial. Trials. 2020 Jun 15;21(1):525. doi: 10.1186/s13063-020-04442-8.

    PubMed 32539850

Questions about this trial

What is this clinical trial studying?

A study testing hominis placental pharmacopuncture in people with Temporomandibular Disorder, run by Jaseng Medical Foundation at 2 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 6 inclusion and 17 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 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The difference in visual analogue scale (VAS) of temporomandibular pain (time frame: Week 6). 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 NCT04087005, which also lists 3 linked publications.

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 2 Jun 2021.

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