Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432484
Status:
COMPLETED
Last Update Posted:
2008-05-09
First Post:
2007-02-06
Brief Title:
Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Lingzhi Ganoderma Lucidum and Sen Miao San Supplementation in Rheumatoid ArthritisRA An Animal Model and A Phase I Study
Status:
COMPLETED
Status Verified Date:
2008-05
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 study the efficacy of TCM as an effective supplement in addition to the traditional treatment in RA
Detailed Description:
It is a prospective double-blind randomized placebo-controlled study in patients with RA It consists of a 24 - weeks period of randomized double-blind treatment of either TCMLingzhi and Sen Miao Sanor placebo
Primary outcome is assessed by showing a clinical response of at least 20 and 50 as defined by the American College of Rheumatology ACR criteriaSecondary outcome is defined as the changes in the number of swollen and tender joint counts and the levels of ESR CRP the inflammatory markers cytokine levels and oxidative stress
Primary outcome is assessed by showing a clinical response of at least 20 and 50 as defined by the American College of Rheumatology ACR criteriaSecondary outcome is defined as the changes in the number of swollen and tender joint counts and the levels of ESR CRP the inflammatory markers cytokine levels and oxidative stress
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