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Clinical Trials/ISRCTN46679573
ISRCTN46679573
Completed
Phase 1

A double-blind, placebo-controlled pilot study to evaluate FruitexB® (calcium fructoborate) effect on systemic inflammation and dyslipidaemia markers in middle-aged people with primary osteoarthritis

atural Research, Ltd (Romania)0 sites72 target enrollmentMarch 17, 2010
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ConditionsPrimary osteoarthritisMusculoskeletal DiseasesPolyarthrosis

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Primary osteoarthritis
Sponsor
atural Research, Ltd (Romania)
Enrollment
72
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2011 results in https://pubmed.ncbi.nlm.nih.gov/21607703/ (added 29/12/2020)

Registry
who.int
Start Date
March 17, 2010
End Date
August 30, 2009
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
atural Research, Ltd (Romania)

Eligibility Criteria

Inclusion Criteria

  • •1\. Men and non\-pregnant women
  • •2\. Aged 40 \- 85 years
  • •3\. Primary OA of at least one knee as demonstrated by a radiological examination carried out within the previous 3 months
  • •4\. Body mass index (BMI) less than 28 and greater than 24\.4 kg/m^2
  • •5\. Elevated blood levels of at least one inflammatory marker

Exclusion Criteria

  • •1\. Individuals with digestion problems
  • •2\. Subjects with a fever and/or under treatment with antibiotics
  • •3\. Subjects with fructose intolerance
  • •4\. Subjects taking any painkillers and/or vitamin B6
  • •5\. Subjects taking aspirin
  • •6\. Current use of non\-steroidal anti\-inflammatory drugs (NSAIDS) and acetominophen

Outcomes

Primary Outcomes

Not specified

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