Investigation of the effects of 8-week continuous ingestion of plant tuber extract on knee joint: a double-blind, randomized and parallel study
- Conditions
- healthy subjects
- Registration Number
- JPRN-UMIN000037556
- Lead Sponsor
- IMEQRD Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
Not provided
1) Currently in treatment with medical products. 2) Currently under exercise and diet treatment. 3) Currently visiting hospital for treatment of knee pain. 4) More than 2 of KL (Kellgren-Lawrence) classification grade. 5) Diagnosed with hyperuricemia and the possible occurrence of an attack of gout. 6) Diagnosed with severe disorders such as diabetes, a circulatory disease, a hepatic disease, a renal disease and a cardiac disease, or previous history. 7) Positive at rheumatoid factor, or may cause pain from rheumatism. 8) Undergone or need knee surgery. 9) Need for pharmacological articular treatments during the study. 10) Undergone a hyaluronic acid injection within two weeks before the selection or a steroid injection within three months before the selection. 11) Diagnosed with bone or joint-related diseases such as a fracture and a sprain within the past three months. 12) Regular intake of health food that contains hyaluronic acid, glucosamine, chondroitin sulfuric acid, quercetin glycoside, vitamin D, or an amino-acid drug, or have the intention of consuming the health food during the study. 13) Regular intake of a medical products with an influence on the evaluation of the study (particularly, a medical products that contains glucosamine, chondroitin sulfuric acid, vitamin D or an amino-acid drug, or a medical products for the treatment of osteoporosis). 14) Excessive alcohol (over 60 g per day) intake. 15) Regular use of a cane. 16) Medical history of drug or food allergy. 17) Having the potential to become pregnant during the study or currently pregnant (including a possibility of being pregnant) or nursing. 18) Currently or history of drug abuse. 19) More than 30 kg / m2 of BMI. 20) Participated in other clinical trials within a month from the date of obtaining consent, or during the study. 21) Matched with exclusion criteria, since submission of an informed consent. 22) Unsuitable for enrollment in the opinion of the principal or sub investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method