The Biological Specificity of Acupoints Between Major Depressive Disorder Patients and Healthy Controls

NCT ID: NCT06114342

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 184 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2022-09-30

Brief Summary

Evidence-based medicine suggests that acupuncture can improve major depressive disorder (MDD). However, the prevalent reliance on experiential acupoint selection lacks scientific underpinning. The investigators conducted a comparative study involving MDD patients and healthy subjects, employing modern techniques to discern biological specificity in MDD-related acupoints. Additionally, the investigators investigated potential correlations between acupoint biological specificity and MDD severity.

Detailed Description

A final total of 134 eligible subjects were included. Among them, 50 healthy subjects were assigned to the healthy control (HC) group and 84 MDD participants were assigned to the MDD group.

Conditions

Major Depressive Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

HC group

There were 50 healthy control participants in the HC group.

No interventions assigned to this group

MDD group

There were 84 MDD patients in the MDD group. 50 MDD subjects were enrolled at each acupoint for each test.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• provided a recent depression screening report, and be free of any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease;
• 18 ≤ age ≤60 years, male or female;
• had clear consciousness and could communicate with others normally; - understand the full study protocol and have high adherence;
• signed the written informed consent.

• consistent with the diagnosis of MDD in the International Classification of Diseases 10th Edition (ICD-10);
• 18 ≤ age ≤ 60, male or female;
• had clear consciousness and could communicate with others normally;
• understand the full study protocol and have high adherence;
• signed the written informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhejiang Provincial Tongde Hospital

OTHER

Sponsor Role: collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role: collaborator

Xiaomei Shao

OTHER

Sponsor Role: lead

Responsible Party

Xiaomei Shao

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiaomei Shao

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated hospital of Zhejiang Chinese Medical University

Locations

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2022ZX010-IP

Identifier Type: -

Identifier Source: org_study_id