Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061717) titled 'Evaluation of the effectiveness of applying warming cream for mild knee pain and discomfort' on June 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Yamada Bee Company, Inc.
Condition:
Condition - Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of the test product for mild knee pain and discomfort.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Apply the test product (warming cream) to the knee for 4 weeks each in summer and winter.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Participants who feel knee pain, fatigue, or discomfort.
2) Japanese adult male and female.
3) Participants who understand and can comply with the rules and guidelines throughout the study period.
4) Participants who have provided written informed consent of their own free will after fully understanding the study details.
Key exclusion criteria - 1. Participants with pain due to gout or rheumatism.
2. Participants with neuropathic or traumatic knee pain.
3. Participants who have undergone or are currently in need of surgery on their knee.
4. Participants with a history of bone or joint-related illnesses such as fractures or sprains within the last 3 months.
5. Participants who are continuously using cosmetics, pharmaceuticals, or quasi-drugs that claim or emphasize efficacy similar to or related to the efficacy to being evaluated in this study.
6. Participants who have changed their regularly used body care products or started using new body care products within the last 4 weeks.
7. Participants who are currently receiving treatment (e.g., hormone replacement therapy, drug therapy, exercise therapy, diet therapy, acupuncture, massage, physical therapy, and other treatments) at a medical institution for the treatment or prevention of knee pain, or who are judged to be in a condition requiring treatment.
8. Participants with a history of alcohol or drug dependence.
9. Participants who have previously experienced skin allergic symptoms from cosmetics or warming products (pharmaceuticals, quasi-drugs, or cosmetics).
10. Participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
11. Participants who have participated in another clinical study (e.g., using cosmetics, foods, drugs, quasi-drugs, or medical devices) within the last 4 weeks prior to informed consent, or who plan to participate in another clinical study during the scheduled period of this study.
12. Participants who are judged to be inappropriate for participation in this study by the principal investigator.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 26 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2027 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070633
Disclaimer: Curated by HT Syndication.
