Status:
COMPLETED
Efficacy and Safety of JHG002 for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial
Lead Sponsor:
Jaseng Medical Foundation
Conditions:
Temporomandibular Disorder
Eligibility:
All Genders
19-70 years
Phase:
NA
Brief Summary
This study is a 2-arm parallel, assessor blinded, multi-centre, randomised controlled trial.
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 phy...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2020
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04087005
Start Date
October 17 2019
End Date
July 21 2020
Last Update
June 2 2021
Active Locations (2)
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1
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, South Korea, 135-896
2
Kyung Hee University Hospital at Gangdong
Seoul, South Korea