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Sponsored by: |
University of Maryland |
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Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00755326 |
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.
Condition | Intervention | Phase |
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Osteoarthritis of the Knee |
Drug: HLXL |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee |
Estimated Enrollment: | 180 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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HLXL: Active Comparator
Active herb
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Drug: HLXL
Three daily dosages will be investigated. The lowest dosage condition will be 6 capsules (2,400 mg) daily, followed by an escalation to the 10 capsule condition (4,000 mg), and then to the 14 capsule (5,600 mg) condition. Participants will be treated for 6 weeks
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Placebo: Placebo Comparator
Placebo HLXL
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Drug: HLXL
Three daily dosages will be investigated. The lowest dosage condition will be 6 capsules (2,400 mg) daily, followed by an escalation to the 10 capsule condition (4,000 mg), and then to the 14 capsule (5,600 mg) condition. Participants will be treated for 6 weeks
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The specific aims of this project are:
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: mary k bahr-robertson, BA | 410-448-6607 | mbahr@compmed.umm.edu |
Contact: deborah taber, BS | 410-448-6809 | dtaber@compmed.umm.edu |
United States, Maryland | |
University of Maryland Center for Integrative Medicine Kernan Hospital | Recruiting |
Baltimore, Maryland, United States, 21207 | |
Principal Investigator: brian m berman, MD |
Principal Investigator: | Brian M. Berman, MD | University of Maryland |
Responsible Party: | University of Maryland ( Brian M. Berman ) |
Study ID Numbers: | H-27497, 1 P01 AT002605-01A1 |
Study First Received: | September 17, 2008 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00755326 |
Health Authority: | United States: Food and Drug Administration |
OA |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Rheumatic Diseases Marijuana Abuse |