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

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

Interventions

DIETARY_SUPPLEMENT

Experimental: Curcumin derivate

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

DIETARY_SUPPLEMENT

Placebo

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.

Sponsors & Collaborators

• KOS Care SRL - Istituto di Riabilitazione Santo Stefano

  lead OTHER

Principal Investigators

• Massimo Frascarello, MD · Istituto Santo Stefano

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-18

Primary Completion

2020-04-30

Completion

2020-06-30