Effectiveness of Curcumin-based Food Supplement in Reducing Pain and Inflammatory Component in Osteoarthritis
Unknown statusNot applicableNCT04207021
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
INTRODUCTION The treatment of OA is mostly symptomatic and includes the use of analgesics, NSAIDs, exercise and even surgery. However, the use of long-term NSAIDs is associated with potentially serious side effects. As a result, the use of alternative and complementary therapies (CAM), such as nutritional therapies in patients with OA, is extremely frequent. The objective of this study will be to evaluate the effectiveness of a dietary supplement based on curcumin, polydatin and beta-caryophyllene, on the reduction of pain and inflammatory component in individuals with knee OA. MATERIAL AND METHOD Study design Intervention study with two parallel arms, randomized, double-blind, placebo-controlled. Study population Participants in the study will be recruited at the Santo Stefano Rehabilitation Institute. The first group will be treated with curcumin-based supplement for 6 weeks; the second group will be treated with placebo for 6 weeks. Inclusion/exclusion criteria Inclusion criteria * Presence of osteoarthritis of the knee. Traditional American College of Rheumatology criteria, which are based on the presence of pain (knee pain) plus at least three of the following characteristics, will be used for the diagnosis of osteoarthritis of the knee: * Age \> 50 years * Stiffness in the morning \< 30 minutes * Presence of articular rusting * Painfulness of the bones * Tumefaction of the bones * Absence of palpable heat Knee pain in this study is defined as having experienced at least moderate pain in the most affected knee (a score of 30 mm or more on an analog visual scale - VAS - as assessed by the patient) for at least 25 of the previous 30 days. Exclusion criteria * pregnancy and breastfeeding * other specific contraindications/intolerances to the compound * intake of other supplements * treatment with anti-inflammatory or pain-relieving drugs for other clinical conditions at the time of enrolment * Participation in other clinical studies All participants will be allowe…
Study details
- Official title
- Evaluation of the Effectiveness of Curcumin-based Food Supplement in Reducing Pain and Inflammatory Component in People With Osteoarthritis
- Conditions
- Interventions
- Dietary supplement: Experimental: Curcumin derivate
- Dietary supplement: Placebo
- Sponsor
- KOS Care SRL - Istituto di Riabilitazione Santo Stefano
- Start date
- 2019-12-18
- Primary completion
- 2020-04-30
- Sex
- All
- Age range
- from 50 Years to 100 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Presence of osteoarthritis of the knee. Traditional American College of Rheumatology criteria, which are based on the presence of pain (gonalgia) plus at least three of the following characteristics, will be used for the diagnosis of osteoarthritis of the knee: * Age \> 50 years * Stiffness in the morning \< 30 minutes * Presence of articular rusting * Painfulness of the bones * Tumefaction of the bones * Absence of palpable heat Exclusion Criteria: * \- pregnancy and breastfeeding (if the potential participant does not declare to be in a menopausal state) * other specific contraindications/intolerances to the compounds contained in the supplement (e.g. celiac disease, allergy) * simultaneous intake of other supplements * to be at the time of enrolment for treatment with anti-inflammatory or pain-relieving treatment for other clinical conditions * Participation in other clinical studies * State of inability to understand or desire
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04207021