Effectiveness of Curcumin-based Food Supplement in Reducing Pain and Inflammatory Component in Osteoarthritis

NCT04207021 | Unknown

• 1 other identifier: FENOXI-19
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 allowed to use analgesics (e.g. paracetamol) to control pain when needed. The patient will, however, be required to avoid / suspend the use of analgesics at least 12 hours before the baseline visit and subsequent checkups.

Conditions

Osteoarthritis; Knee Pain Chronic

Keywords

Curcumin

Outcome Measures

Primary Outcomes (1)

• - variation in the level of joint function measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  WOMAC scale is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The test questions are scored on a 0-4 scale, corresponding to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up; higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations

  0, 6 weeks

Secondary Outcomes (3)

• - variation of serum levels of C-reactive Protein (CRP)

  6 weeks

• - variations of saliva levels of TNF-alpha, IL-1beta, IL-6, nitrates/nitrites

  6 weeks

• - variation in the use of painkillers

  6 weeks

Study Arms (2)

intervention

EXPERIMENTAL

the study involves the intake of two capsules per day, one capsule to be taken before breakfast and one before dinner for a period of 6 weeks of a nutritional supplement INTERVENTION CAPSULE COMPOSITION active substances for 2 capsules Bio Curcumin 400 mg Polydatin 00 mg Beta-Caryophyllene 48 mg

Dietary Supplement: Experimental: Curcumin derivate

placebo

PLACEBO COMPARATOR

particpants included in the placebo group will take two capsules per day (containing no bioactive compound, only hydroxypropyl methylcellulose, gellan gum, pigment), one capsule to be taken before breakfast and one before dinner for a period of 6 weeks.

Dietary Supplement: Placebo

Interventions

Experimental: Curcumin derivate DIETARY_SUPPLEMENT

two capsules per day, one capsule to be taken before breakfast and one before dinner for a period of 6 weeks.

intervention

Placebo DIETARY_SUPPLEMENT

two capsules per day (containing no bioactive compound, only hydroxypropyl methylcellulose, gellan gum, pigment), one capsule to be taken before breakfast and one before dinner for a period of 6 weeks.

placebo

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• KOS Care SRL - Istituto di Riabilitazione Santo Stefano: lead

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Massimo Frascarello, MD

  Istituto Santo Stefano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimo Frascarello, MD

CONTACT

+3907336891; massimo.frascarello@sstefano.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 20, 2019
• Study Start: December 18, 2019
• Primary Completion: April 30, 2020
• Study Completion: June 30, 2020
• Last Updated: December 20, 2019

Record last verified: 2019-12