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A human trial to evaluate the efficacy and safety of steamed Zingiber officinale Roscoe extract powder on joint health

Not Applicable
Completed
Conditions
Diseases of the musculoskeletal system and connective tissue
Registration Number
KCT0006335
Lead Sponsor
Woosuk University Korean Medicine Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
100
Inclusion Criteria

1) Participants currently with one or both knees pain
2) Participants with 1~2 of Kellgren Lawrence grade(KL grade)
3) Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions

Exclusion Criteria

1) Patients with a clinically significant disease requiring treatment (i.e., cardiovascular system, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric system, musculoskeletal inflammation, inflammatory disease, blood and tumor disease, gastrointestinal disease, etc.)
2) Patients who take medicine for joint health and intake health functional food within a month prior to the screening examination
3) Patients with a history of antipsychotic medication use within 3 months prior to the screening examination
4)Patients who have participated in other clinical trials within 3 months prior to the screening examination
5)Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Korean Western Ontario and McMaster Universities Osteoarthritis Index(K-WOMAC) total scores;Visual analog scale(VAS)
Secondary Outcome Measures
NameTimeMethod
Korean Western Ontario and McMaster Universities Osteoarthritis Index(K-WOMAC) sub-scores: pain, stiffness, function;Patient global assessment(PGA)
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