Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05772104
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-16
First Post:
2023-03-06
Brief Title:
Randomized Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
Sponsor:
Sichuan Jishengtang Pharmaceutical Co Ltd
Organization:
Chengdu Kanghong Pharmaceutical Group Co Ltd
Study Overview
Official Title:
A Multi-center Randomized Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial was a multi-center randomized double-blind two-stage clinical trial in patients with generalized anxiety disorder TCM differentiated as liver Qi stagnation and spleen deficiency syndrome consisting of a exploratory studystage 1 and a confirmatory studystage 2
In stage 1 120 subjects were enrolled and randomly assigned to high-dose group low-dose group and placebo group at a ratio of 111
In stage 2 440 subjects final sample size was re-estimated based on the results of stage 1 were randomly assigned to the experimental and placebo groups at a ratio of 11
In stage 1 120 subjects were enrolled and randomly assigned to high-dose group low-dose group and placebo group at a ratio of 111
In stage 2 440 subjects final sample size was re-estimated based on the results of stage 1 were randomly assigned to the experimental and placebo groups at a ratio of 11
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None