A Study to Evaluate the Efficacy of Phellinus linteus Extract on Knee Articulation Health
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0004266
- Lead Sponsor
- Cheonan Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 24
(1) 40-75 year old male and female with knee pain for 6 months or more
(2) A Kellgren-Lawrence grading scale of 1 grade or 2 grade on both knee X-ray examinations
(3) If subject is taking arthritic medications, subject has not changed his/her medication within the past a month
(4) Subject who agrees to participate in the study and signs the informed consent form
(1) A patient who are currently being treated for clinically significant acute or chronic cardiocerebrovascular system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal disorders, mental, infectious and blood and tumor diseases
(2) A person who is arthritis due to a specific factor other than degenerative
(3) Those who have a history of fractures of the lower limb within the last 3 months
(4) Those who have creatinine blood level that is more than twice the normal upper limit of the organ
(5) A patient who received intra-articular injection with hyaluronic acid or steroids within 3 months of the study
(6) Those who have AST or ALT blood level that is 3 times higher than normal upper limit
(7) Those who have uncontrolled hypertension(160/100mmHg ??)
(8) Patients taking medication for psychiatric disorders
(9) Those who have been taking herbal medicine for the last two weeks
(10) Those who have received other research drugs within the last 4 weeks
(11) Persons who must continue to take drugs that they think may affect the results of clinical trial
(12) Those who have a history of gastrointestinal resection
(13) Those who have had artificial joint surgery
(14) Those who are pregnant or breastfeeding
(15) Alcoholic or drinking more than 4 times/week
(16) Persons with hypersensitivity to the research food or its components
(17) Any other researcher deemed inappropriate for this test
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method K-WOMAC(Korean Western ontario and McMaster Universities Questionnaire) (pain, rigidity, physical function)
- Secondary Outcome Measures
Name Time Method VAS(Visual Analog Scale);EQ-5D(EuroQol-5D);Inflammation markers;Adverse event