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Treatment of Patients With Chronic Osteoarthritis With Ginger Kidney Compress - a Randomized, Controlled Trial (OST_02)

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ginger compress
Sponsored by
ARCIM Institute Academic Research in Complementary and Integrative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic osteoarthritis, mainly osteoarthritis of the knee
  • osteoarthritis symptoms for at least six months
  • written consent to participate in the study
  • Age: 30 years and more

Exclusion Criteria:

  • Rheumatoid Arthritis
  • Fibromyalgia
  • Oncological or other serious diseases
  • Use of corticosteroids
  • Nephropathy
  • Non-intact skin conditions in the area of application
  • Hypersensitivity / allergy to ginger
  • Simultaneous participation in another clinical trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Ginger compress

    Wait list

    Arm Description

    Outcomes

    Primary Outcome Measures

    Total Sum Score (WOMAC)

    Secondary Outcome Measures

    Change in medication

    Full Information

    First Posted
    January 10, 2014
    Last Updated
    August 7, 2019
    Sponsor
    ARCIM Institute Academic Research in Complementary and Integrative Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02044432
    Brief Title
    Treatment of Patients With Chronic Osteoarthritis With Ginger Kidney Compress - a Randomized, Controlled Trial
    Acronym
    OST_02
    Official Title
    Treatment of Patients With Chronic Osteoarthritis (Gonarthrosis) With Ginger Kidney Compress - a Randomized, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    ARCIM Institute Academic Research in Complementary and Integrative Medicine

    4. Oversight

    5. Study Description

    Brief Summary
    The investigators hypothesize that by a 5-week treatment with ginger kidney compresses at least 2 of 3 main symptoms of the WOMAC (pain, stiffness, functionality) will be reduced at least 30% at the time of the post-measurement (after 5 weeks of therapy) in comparison to the respective control group (waitlist).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ginger compress
    Arm Type
    Experimental
    Arm Title
    Wait list
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    ginger compress
    Intervention Description
    Kidney ginger compress
    Primary Outcome Measure Information:
    Title
    Total Sum Score (WOMAC)
    Time Frame
    Change from baseline at 5 weeks of treatment and 5 weeks follow up
    Secondary Outcome Measure Information:
    Title
    Change in medication
    Time Frame
    After 5 weeks of treatment and 5 weeks follow up
    Other Pre-specified Outcome Measures:
    Title
    Sum Score of "Short Arthritis Assessment Scale" questionnaire
    Time Frame
    After 5 weeks of treatment and 5 weeks follow up
    Title
    Parameters of a warmth questionnaire
    Time Frame
    After 5 weeks of treatment and 5 weeks follow up
    Title
    Range of knee movement
    Time Frame
    After 5 weeks of treatment and 5 weeks follow up
    Title
    Thermography (body heat distribution)
    Time Frame
    After 5 weeks of treatment and 5 weeks follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic osteoarthritis, mainly osteoarthritis of the knee osteoarthritis symptoms for at least six months written consent to participate in the study Age: 30 years and more Exclusion Criteria: Rheumatoid Arthritis Fibromyalgia Oncological or other serious diseases Use of corticosteroids Nephropathy Non-intact skin conditions in the area of application Hypersensitivity / allergy to ginger Simultaneous participation in another clinical trial

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment of Patients With Chronic Osteoarthritis With Ginger Kidney Compress - a Randomized, Controlled Trial

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