NCT05923021|UnknownDMC
Moderate Depressive Disorder With Cheek Acupuncture
A Randomized Controlled Study on the Treatment of Moderate Depressive Disorder With Cheek Acupuncture
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A Randomized Controlled Study on the Treatment of Moderate Depressive Disorder With Cheek Acupuncture
Sponsor study identifier
interventional
126
0 countries
N/A
Study Start
July 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study intends to use a randomized controlled clinical study to clarify the clinical efficacy of cheek acupuncture therapy in patients with moderate depressive disorder. And also to find the antidepressant mechanism of cheek acupuncture therapy on moderate depressive disorder by using resting state functional magnetic resonance imaging. The specific method is to randomly assign 126 patients with moderate depressive disorder to cheek acupuncture group, sham cheek acupuncture group and drug group, evaluate the treatment effect with HAMD-17, PSQI and HAMA, observe the improvement of cheek acupuncture on depression, anxiety and sleep quality of patients with moderate depressive disorder, and observe the changes of functional links in various brain regions of patients in each group before and after treatment through resting state functional magnetic resonance imaging technology.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 19, 2023
Actual (reported)June 28, 2023
Actual (reported)July 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change HAMD-17 score is being assessed at different time points
The most commonly used scale for clinical assessment with depression. A score more than or equal to 24 indicates severe depression, a score more than or equal to 17 and less than 24 indicates moderate depression, and a score less than 7 indicates no depression.
Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks
Change PSQI score is being assessed at different time points
Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks
Change HAMA score is being assessed at different time points
Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks
Needle selection: Select disposable trocars（φ0.18 × 25mm） (Wujiang Jiachen acupuncture and moxibustion Instrument Co., Ltd.) . Acupoints selection: bilateral Sanjiao points, bilateral head points, bilateral neck points, Needling depth: about 5mm-7.5mm, Needle retaining time: 30 minutes, course of treatment: 3 times a week, with a total of 36 cheek acupuncture treatments for 12 weeks.
Needle selection: Select disposable flat head trocars（φ0.18 × 25mm） (Wujiang Jiachen acupuncture and moxibustion Instrument Co., Ltd.) . Acupoints selection: Translate the bilateral Sanjiao points forward by 1cm（towards the front midline of the body）, translate the bilateral head points forward by 1cm, bilateral back points, Needling depth: Retained on the surface of the skin with the help of a cannula， Needle retaining time: 30 minutes, course of treatment: 3 times a week, with a total of 36 times of cheek acupuncture treatments for 12 weeks.
Cheek acupuncture therapy refers to a new painless acupuncture therapy for treating systemic diseases by acupuncture at specific points on the cheek. This therapy was founded by Professor Wang Yongzhou, a scholar in France. Cheek acupuncture therapy takes the Yellow Emperor's Internal Classic as the theoretical basis, and organically integrates holographic theory, the theory of ascending and descending qi, the theory of Big Three Jiao, the theory of simultaneous treatment of mind and body, and the theory of the book of Changes.In this study, we use the big three jiao points, head points, and neck points in cheek acupuncture therapy to treat depression. These acupoints are considered effective in long-term clinical applications.
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First Submitted
May 19, 2023
First Posted
Personalise Antidepressant Treatment for Unipolar Depression Combining Individual Choices, Risks and Big Data
Drug name: Sertraline Hydrochloride Tablets (trade name: Levofloxacin Sertraline, produced by Pfizer Pharmaceutical Co., Ltd., batch number: H10980141), Dosage form: tablets Usage: Take orally. 50 mg/d, taken after breakfast. Depending on the patient's condition, the dosage can be increased to 200mg/d, taken after breakfast, or divided twice a day after meals Treatment cycle: a total of 12 weeks.
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June 28, 2023
Study Start
July 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 28, 2023
Record last verified: 2023-06
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