A confirmation study about relaxation of knee-joint discomfort by test-food intake
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000040804
- Lead Sponsor
- IMEQRD CO., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
Subjects with [] [1] some symptoms just like a muscular pain on a daily basis. [2] some kind of medical treatment. [3] diet/exercise therapies under the instruction of a medical doctor. [4] therapies at an orthopedic or a pain-clinic. [5] the grade II (and over) on a basis of KL (Kellgren-Lawrence) classification. [6] previous history of some kind of knee-treatment (e.g., artificial knee replacement), or any necessity to treat their knee joint. [7] a planning application of their knee-joint to some kind of drug-therapy. [8] injections of hyaluronic acid to their knee-joint within two weeks before the agreement for the trial, or steroid to their's within three months before the agreement. [9] previous history of diseases relating to the knee joint, such as a bone fracture, a sprain, etc. [10] health-specific/functional/health foods that might affect the test results. [11] the help of a stick on a daily basis. [12] not less than 30 kg/m2 BMI. [13] pregnancy, possible one, or lactation. [14] previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. [15] excessive alcohol intake. [16] extremely irregular life rhythms, midnight work or irregular shift work. [17] previous medical history of drug and/or food allergy. [18] the other clinical tests with some kind of medicines/foods, or taking part in those tests within four weeks after the current trial. [19] donation of over 200 mL of their whole blood and/or blood components within a month to the current trial. (20) Males who donated over 400 mL of their whole blood within the last three months to the current trial. (21) Females who donated over 400 mL of their whole blood within the last four months to the current trial. (22) Males who are going to be collected over 1200 mL within the last twelve months. (23) Females who are going to be collected over 800 mL within the last twelve months. (24) Others who have been determined as ineligible for participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Visual Analog Scale (VAS)- questionnaire scores about some kind of knee-joint discomfort. 2. Japanese Knee Osteoarthritis Measure (JKOM)-questionnaire scores.
- Secondary Outcome Measures
Name Time Method 1. EuroQOL 5 dimensions 5-level (EQ-5D-5L)-questionnaire scores about quality of life. 2. Activity of Daily Living (ADL)-test 3. Adverse events, and incidence rate of side effects