CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 92 enrolled
Drug / intervention
HLXLdrug
Likely dose
HLXL 4,000mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00755326
NCT00755326Phase 2Completed
CompareCT.gov

Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee

University of Maryland, Baltimore·interventional·Posted Sep 18, 2008·Updated Jan 18, 2020

In Brief

A Phase 2 clinical trial evaluating HLXL for Osteoarthritis of the Knee. Completed, enrolled 92 participants across 1 site.

Detailed 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 treatment(s) and also to determine the best dosage of HLXL that is safe and well tolerated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis of the Knee
CountriesUnited States
CollaboratorsNational Center for Complementary and Integrative Health (NCCIH)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 18, 2008
Enrollment StartApr 1, 2007
Primary CompletionApr 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 17.8 years ago

Interventions

HLXLdrug

Two daily dosages will be investigated. Huo-Luo-Xiao-Ling (HLXL) dose (10 capsules/day or 4,000mg/day) in the first 2 weeks to evaluate safety. If no adverse effects were observed, the dose was increased to 14 capsules per day (5,600 mg/ day) for the subsequent 6 weeks.