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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

Tracking Information
First Submitted Date  ICMJE May 6, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date October 15, 2018
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
Pain intensity [ Time Frame: 4 weeks ]
pain intensity measured on three 0-100mm visual analogous scales (actual, mean, worst pain)
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2018)
Pain intensity [ Time Frame: 4 weeks ]
pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)
Change History Complete list of historical versions of study NCT03528824 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2018)
  • knee function (WOMAC) physical everyday function using the validated WOMAC questionnaire [ Time Frame: 4 weeks ]
    physical everyday function using the validated WOMAC questionnaire
  • measure yourself medical outcome profile (MYMOP) [ Time Frame: 4 weeks ]
    evaluation of symptoms and limitations
  • Quality of Life (SF-36) [ Time Frame: 4 weeks ]
    health related quality of life with the validated SF-36 questionnaire
  • self-efficacy (ASES-D) [ Time Frame: 4 weeks ]
    self-efficacy with the arthritis specific self efficacy scale in German
  • 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)
  • Course of Pain [ Time Frame: 4 weeks ]
    measured by a diary including pain intensity on a visual analogue scale, medication
  • Pressure pain sensitivity [ Time Frame: 4 weeks ]
    measured by an algometer at predefined areas
  • Adverse events Safety measure [ Time Frame: 4 weeks ]
    safety measure
  • knee function (WOMAC) [ Time Frame: 12 weeks ]
    physical everyday function using the validated WOMAC questionnaire
  • measure yourself medical outcome profile (MYMOP) [ Time Frame: 12 weeks ]
    evaluation of symptoms and limitations
  • Quality of Life (SF-36) [ Time Frame: 12 weeks ]
    health related quality of life with the validated SF-36 questionnaire
  • self-efficacy (ASES-D) [ Time Frame: 12 weeks ]
    self-efficacy with the arthritis specific self efficacy scale in German
  • Course of Pain [ Time Frame: 12 weeks ]
    measured by a diary including pain intensity on a visual analogue scale, medication
  • Adverse events [ Time Frame: 12 weeks ]
    safety measure
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2018)
  • knee function (WOMAC) physical everyday function using the validated WOMAC questionnaire [ Time Frame: 4 weeks ]
    physical everyday function using the validated WOMAC questionnaire
  • measure yourself medical outcome profile (MYMOP) [ Time Frame: 4 weeks ]
    evaluation of symptoms and limitations
  • Quality of Life (SF-36) [ Time Frame: 4 weeks ]
    health related quality of life with the validated SF-36 questionnaire
  • self-efficacy (ASES-D) [ Time Frame: 4 weeks ]
    self-efficacy with the arthritis specific self efficacy scale in German
  • 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)
  • Course of Pain [ Time Frame: 4 weeks ]
    measured by a diary including pain intensity on a visual analogue scale, medication
  • Pressure pain sensitivity [ Time Frame: 4 weeks ]
    measured by an algometer at predefined areas
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fenugreek Wraps in Osteoarthritis of the Knee
Official Title  ICMJE Randomised Controlled Trial on the Efficacy of Fenugreek Wraps in Symptomatic Primary Gonarthrosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Other: Fenugreek wrap
    Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application
  • Drug: Diclofenac Gel
    Daily application of diclofenac gel, 4 weeks application
    Other Name: Diclofenac Emulgel
Study Arms  ICMJE
  • Experimental: Fenugreek wraps
    Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application
    Intervention: Other: Fenugreek wrap
  • Active Comparator: Diclofenac gel
    Daily application of diclofenac gel, 4 weeks application
    Intervention: Drug: Diclofenac Gel
  • No Intervention: Usual care
    no specific intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2018)
81
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2019
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Petra Klose, PhD 004920117425051 p.klose@kliniken-essen-mitte.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03528824
Other Study ID Numbers  ICMJE BoGon
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Petra Klose, Universität Duisburg-Essen
Study Sponsor  ICMJE Universität Duisburg-Essen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universität Duisburg-Essen
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP