Status:
UNKNOWN
Acupuncture Therapy Based on Biological Specificity of Acupoints for Major Depressive Disorder
Lead Sponsor:
The Third Affiliated hospital of Zhejiang Chinese Medical University
Collaborating Sponsors:
The Zhejiang Provincial Tongde Hospital
The Affiliated Hangzhou First People's Hospital
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
12-60 years
Phase:
NA
Brief Summary
Acupoints are the stimulus points and reactive points for acupuncture to treat the diseases. Therefore, this study is designed to detect the biological specificity of acupoints in healthy participants...
Detailed Description
Part 1: This study will include 40 patients with MDD and 40 healthy control participants. Infrared thermography (IRT), laser doppler flowmetry (LDF), functional near-infrared spectroscopy (FNIS), and ...
Eligibility Criteria
Inclusion
- Inclusion criteria for health volunteers:
- Healthy volunteers who could provide a recent depression screening report, and confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease;
- 12 ≤ age ≤60 years, male or female;
- Participants have clear consciousness and could communicate with others normally;
- Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin (for minor participants, their guardian should sign the informed consent form for them).
- Inclusion criteria for MDD:
- Patients should meet the diagnostic criteria of the International Classification of Diseases 10th Edition (ICD-10) diagnostic criteria for depression and are evaluated as moderate or severe MDD according to the severity of depression;
- 12 ≤ age ≤60, male or female;
- Participants have clear consciousness and could communicate with others normally;
- Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin (for minor participants, their guardian should sign the informed consent form for them).
Exclusion
- Exclusion criteria of health volunteers:
- Participants with serious primary diseases of cardiovascular diseases, liver diseases, kidney diseases, urinary diseases, and hematological diseases;
- Participants have a mental illness, alcohol dependence, or a history of drug abuse;
- Pregnant or lactating participants;
- Participants are participating in other trials.
- Exclusion criteria for MDD:
- Participants with serious primary diseases of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, neurological disease, and other serious primary diseases, and the disease cannot be effectively controlled clinically;
- Major depressive disorders caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances;
- Participants with suicidal tendencies;
- Pregnant or lactating participants;
- Participants taking other antidepressants that were not SSRIs or the pharmacological effects of such antidepressants have not been cleared;
- Participants with intellectual disabilities who cannot cooperate with the questionnaire survey;
- Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
- The skin at the test site of participants has scars, hyperpigmentation, red and swollen;
- Participants are participating in other trials.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05353543
Start Date
May 1 2022
End Date
December 30 2025
Last Update
April 29 2022
Active Locations (1)
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1
the Third affiliated hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang, China