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Trial record 7 of 21 for:    fenugreek

Fenugreek Wraps in Osteoarthritis of the Knee (BoGon)

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ClinicalTrials.gov Identifier: NCT03528824
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Petra Klose, Universität Duisburg-Essen

Brief Summary:
This randomised controlled trial aims to investigate the efficacy of fenugreek wraps in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised into one of 3 groups and apply fenugreek wraps or diclofenac gel daily for 4 weeks or receive only usual care. Efficacy will be measured using questionnaire on pain, disability,function, quality of life and pressure pain sensitivity.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Other: Fenugreek wrap Drug: Diclofenac Gel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial on the Efficacy of Fenugreek Wraps in Symptomatic Primary Gonarthrosis
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Fenugreek wraps
Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application
Other: Fenugreek wrap
Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application

Active Comparator: Diclofenac gel
Daily application of diclofenac gel, 4 weeks application
Drug: Diclofenac Gel
Daily application of diclofenac gel, 4 weeks application
Other Name: Diclofenac Emulgel

No Intervention: Usual care
no specific intervention



Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 4 weeks ]
    pain intensity measured on three 0-100mm visual analogous scales (actual, mean, worst pain)


Secondary Outcome Measures :
  1. knee function (WOMAC) physical everyday function using the validated WOMAC questionnaire [ Time Frame: 4 weeks ]
    physical everyday function using the validated WOMAC questionnaire

  2. measure yourself medical outcome profile (MYMOP) [ Time Frame: 4 weeks ]
    evaluation of symptoms and limitations

  3. Quality of Life (SF-36) [ Time Frame: 4 weeks ]
    health related quality of life with the validated SF-36 questionnaire

  4. self-efficacy (ASES-D) [ Time Frame: 4 weeks ]
    self-efficacy with the arthritis specific self efficacy scale in German

  5. physical function (30second chair test) [ Time Frame: 4 weeks ]
    validated test to measure how often patients can stand up from a chair in 30 seconds)

  6. Course of Pain [ Time Frame: 4 weeks ]
    measured by a diary including pain intensity on a visual analogue scale, medication

  7. Pressure pain sensitivity [ Time Frame: 4 weeks ]
    measured by an algometer at predefined areas

  8. Adverse events Safety measure [ Time Frame: 4 weeks ]
    safety measure

  9. knee function (WOMAC) [ Time Frame: 12 weeks ]
    physical everyday function using the validated WOMAC questionnaire

  10. measure yourself medical outcome profile (MYMOP) [ Time Frame: 12 weeks ]
    evaluation of symptoms and limitations

  11. Quality of Life (SF-36) [ Time Frame: 12 weeks ]
    health related quality of life with the validated SF-36 questionnaire

  12. self-efficacy (ASES-D) [ Time Frame: 12 weeks ]
    self-efficacy with the arthritis specific self efficacy scale in German

  13. Course of Pain [ Time Frame: 12 weeks ]
    measured by a diary including pain intensity on a visual analogue scale, medication

  14. Adverse events [ Time Frame: 12 weeks ]
    safety measure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • osteoarthritis of the knee, Kellgren Lawrence stadium 2-3
  • at least 50% of days with complaints in past 3 months
  • initial pain intensity >45mm on a 100mm visual analoge scale

Exclusion Criteria:

  • systemic medication with corticoids or immunosuppressive drugs
  • systemic medication with chondroitinsulfate or glucosamine
  • secondary arthrosis
  • operation on the knee within the past 12 months
  • injection within 4 weeks (cortisone) or 6 months prior (hyaluronic acid)
  • severe comorbidities (tumor, psychiatric disorders etc.)
  • participation in other studies, regarding gonarthrosis
  • asthma
  • pregnancy, breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528824


Contacts
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Contact: Petra Klose, PhD 004920117425051 p.klose@kliniken-essen-mitte.de

Locations
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Germany
• Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen Recruiting
Essen, Germany
Contact: Petra Klose, Dr.       p.klose@kliniken-essen-mitte.de   
Sponsors and Collaborators
Universität Duisburg-Essen

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Responsible Party: Petra Klose, PhD, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT03528824     History of Changes
Other Study ID Numbers: BoGon
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Fenugreek seed meal
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents