Study on the regulation mechanism of

Phase 1

• Conditions: Mild to moderate depressive disorder

• Registration Number: ITMCTR2200006669
• Lead Sponsor: Beijing University 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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Han nationality, aged from 18 to 60 years old, male or female;

(2) Those with simple constitution or combined constitution that meet the criteria of mild constitution / yang deficiency constitution;

(3) 17 items Hamilton Depression Scale (HAMD-17) score < 7;

(4) Among those with Yang deficiency constitution, those with kidney yang deficiency;

(5) Normal routine physical examination or no other clear disease diagnosis;

(6) Living in Beijing in recent 2 years;

(7) Know and understand the contents of this study, and voluntarily sign the informed consent form.

Exclusion Criteria

(1) Those with more than two other constitutions;

(2) Special dual Constitution: mild constitution and yang deficiency constitution tendency, qi depression constitution tendency, Yang deficiency constitution and qi depression constitution;

(3) Those who have used glucocorticoids, antibiotics, microecological regulators and gastrointestinal motility drugs in the past month;

(4) Those who participated in clinical research of other drugs within 1 month before screening.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Peripheral plasma neurotransmitter concentration;Feces 16S;Score of TCM constitution Scale;FS-14;Serum non targeted metabolome;SHAPs;Fecal metagenome;HAMD17;Fecal metabolome;Rapid assessment scale of depression QIDS-SR16;