Effect of acupuncture on gut microbiota and host metabolisim of patients with PPD

Phase 1

Recruiting

• Conditions: postpartum depressive disorder

• Registration Number: ITMCTR1900002385
• Lead Sponsor: Shenzhen Hospital of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria for PPD
The participants meet all of the following requirements will be considered for enrolment: (1) be diagnosed with PPD by psychiatrist; (2) onset of disease within 12 months after delivery; (3) the scores of 17 items-Hamilton Rating Scale ranging (17-HAMD) from 7 to 24; (4) 20 to 49 years old; (5) sign informed consent form for volunteering to participate in this study.
Inclusion criteria for healthy subjects
The healthy subjects in this study have to meet all followings: (1) be aged 20 to 49 years old; (2) has no obvious discomfort; (3) normal health examination after delivery (routine blood count, liver and kidney functions, electrocardiogram); (4) the scores of 17-HAMD is less than 7; (5) sign informed consent form for volunteering to participate in this study.

Exclusion Criteria

Exclusion criteria for PPD
Patients with any one of the following conditions will be excluded from this trial: (1) bipolar disorder (diagnostic criteria according to of DSM-?), serious mental diseases such as schizophrenia; (2) dysnoesia or having difficulty in understanding the content of the questionnaire due to brain diseases or other reasons, or incapable of effective interview; (3) the pregnancy; (4) the score of suicide items in 17-HAMD more than 2; (5) have committed suicide nearly 1 year.
Exclusion criteria for healthy subjects
Participants with any one of the following conditions will be excluded from this trial: (1) the pregnancy; (2) have committed suicide nearly 1 year; (3) are involved in other clinical trials.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HAMD;

Secondary Outcome Measures

Name	Time	Method
Edinburgh Postnatal Depression Scale;Gut microbiota;