Ignite Creation Date:
2024-05-05 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00755326
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2008-09-17
Brief Title:
Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee
Status:
COMPLETED
Status Verified Date:
2020-01
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:
TCM-OAK
Brief Summary:
The purpose of this study is to determine if the traditional Chinese herbal compound Huo-Luo-Xiao-Ling Dan or HLXL is effective in treating OA of the knee in addition to participants current OA of the knee treatments and also to determine the best dosage of HLXL that is safe and well tolerated
Detailed Description:
The specific aims of this project are
1 To determine whether HLXL improves pain andor function in patients with OA of the knee who continue to have symptoms despite receiving standard analgesic andor anti-inflammatory treatment
2 To identify an optimal dosage of HLXL among two dosages as determined by pain relief andor functional improvement in a dose-escalation placebo-controlled double-blind randomized phase II clinical trial in conjunction with indicia of safety and tolerability in patients with OA of the knee who are receiving standard analgesic andor anti-inflammatory treatment
3 To explore mechanisms of action of HLXL correlating changes in biological markers of suppression of systemic inflammation with changes in clinical response
1 To determine whether HLXL improves pain andor function in patients with OA of the knee who continue to have symptoms despite receiving standard analgesic andor anti-inflammatory treatment
2 To identify an optimal dosage of HLXL among two dosages as determined by pain relief andor functional improvement in a dose-escalation placebo-controlled double-blind randomized phase II clinical trial in conjunction with indicia of safety and tolerability in patients with OA of the knee who are receiving standard analgesic andor anti-inflammatory treatment
3 To explore mechanisms of action of HLXL correlating changes in biological markers of suppression of systemic inflammation with changes in clinical response
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U19AT003266-01 | NIH | None | httpsreporternihgovquickSearchU19AT003266-01 |