Pre clinical evaluation of Jieyu II granule in the treatment of depressio

Phase 1

• Conditions: Depression

• Registration Number: ITMCTR2000004134
• Lead Sponsor: Shanghai Municipal Hospital 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: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Both male and female, aged from 18 to 70 years (including 18 and 70 years old).
2. According to the diagnosis of mild to moderate depression, the score of Hamilton Depression Scale (17 item version) was 7 to 17.
3. Sign written informed consent.

Exclusion Criteria

1. The score of Hamilton Depression Scale (17 item version) was less than 7 or > 18;
2. Excluding organic mental disorders, or depression caused by psychoactive substances and non addictive substances;
3. Women who are pregnant, breastfeeding or may become pregnant during the study and are unable to take effective contraceptive measures;
4. Obvious symptoms of heart, liver, kidney or other systems;
5. Laboratory examination and ECG examination have obvious clinical significance abnormalities, which can affect the drug evaluation or the safety of the subjects;
6. AST and ALT were 2.0 times higher than the upper limit of normal value;
7. Participated in other clinical drug research in the last month.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale;