Ignite Creation Date:
2024-05-06 @ 1:45 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04111341
Status:
COMPLETED
Last Update Posted:
2019-10-01
First Post:
2019-09-26
Brief Title:
A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögrens Syndrome
Sponsor:
Chung Shan Medical University
Organization:
Chung Shan Medical University
Study Overview
Official Title:
A Double Blind Randomized Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögrens Syndrome
Status:
COMPLETED
Status Verified Date:
2019-09
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:
To investigate the efficacy and safety of traditional Chinese medicine in patients with Sjogrens syndrome
Detailed Description:
This is 2 years double blind randomized placebo-controlled clinical trial Patients fulfilled the classification criteria of Sjogren syndrome will be recruited Eligible subjects will be randomized on a 21 ratio to Traditional Chinese Medicine TCM granules or placebo for 12 weeks The treatment group will receive a combination formula with traditional Chinese medicine Gan-Lu-Yin in the morning and Jia-wei-Xiao-yao-San in the evening Primary endpoint is the ESSPRI European Sjogren Syndrome Patient Reported Outcome Index Secondary endpoints include disease activity index ESSDAI patient global assessment PGA VAS pain scale Quality of Life by Short Form-36 SF-36 fatigue scale and related serological markers Thirty patients will be enrolled in the first year After interim analysis at the end of first year sample size will be recalculated base on the interim analysis results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None