search
Back to results

Fenugreek Wraps in Osteoarthritis of the Knee (BoGon)

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Fenugreek wrap
Diclofenac Gel
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

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

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

Sites / Locations

  • • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Fenugreek wraps

Diclofenac gel

Usual care

Arm Description

Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application

Daily application of diclofenac gel, 4 weeks application

no specific intervention

Outcomes

Primary Outcome Measures

Pain intensity
pain intensity measured on three 0-100mm visual analogous scales (actual, mean, worst pain)

Secondary Outcome Measures

knee function (WOMAC)
physical everyday function using the validated WOMAC questionnaire
measure yourself medical outcome profile (MYMOP)
evaluation of symptoms and limitations
Quality of Life (SF-36)
health related quality of life with the validated SF-36 questionnaire
self-efficacy (ASES-D)
self-efficacy with the arthritis specific self efficacy scale in German
physical function (30second chair test)
validated test to measure how often patients can stand up from a chair in 30 seconds)
Course of Pain
measured by a diary including pain intensity on a visual analogue scale, medication
Pressure pain sensitivity
measured by an algometer at predefined areas
Adverse events Safety measure
safety measure
knee function (WOMAC)
physical everyday function using the validated WOMAC questionnaire
measure yourself medical outcome profile (MYMOP)
evaluation of symptoms and limitations
Quality of Life (SF-36)
health related quality of life with the validated SF-36 questionnaire
self-efficacy (ASES-D)
self-efficacy with the arthritis specific self efficacy scale in German
Course of Pain
measured by a diary including pain intensity on a visual analogue scale, medication
Adverse events
safety measure
Pain intensity
pain intensity measured on a three 0-100mmvisual analogous scales (actual, mean, worst pain)

Full Information

First Posted
May 6, 2018
Last Updated
October 5, 2021
Sponsor
Universität Duisburg-Essen
search

1. Study Identification

Unique Protocol Identification Number
NCT03528824
Brief Title
Fenugreek Wraps in Osteoarthritis of the Knee
Acronym
BoGon
Official Title
Randomised Controlled Trial on the Efficacy of Fenugreek Wraps in Symptomatic Primary Gonarthrosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fenugreek wraps
Arm Type
Experimental
Arm Description
Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application
Arm Title
Diclofenac gel
Arm Type
Active Comparator
Arm Description
Daily application of diclofenac gel, 4 weeks application
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
no specific intervention
Intervention Type
Other
Intervention Name(s)
Fenugreek wrap
Intervention Description
Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application
Intervention Type
Drug
Intervention Name(s)
Diclofenac Gel
Other Intervention Name(s)
Diclofenac Emulgel
Intervention Description
Daily application of diclofenac gel, 4 weeks application
Primary Outcome Measure Information:
Title
Pain intensity
Description
pain intensity measured on three 0-100mm visual analogous scales (actual, mean, worst pain)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
knee function (WOMAC)
Description
physical everyday function using the validated WOMAC questionnaire
Time Frame
4 weeks
Title
measure yourself medical outcome profile (MYMOP)
Description
evaluation of symptoms and limitations
Time Frame
4 weeks
Title
Quality of Life (SF-36)
Description
health related quality of life with the validated SF-36 questionnaire
Time Frame
4 weeks
Title
self-efficacy (ASES-D)
Description
self-efficacy with the arthritis specific self efficacy scale in German
Time Frame
4 weeks
Title
physical function (30second chair test)
Description
validated test to measure how often patients can stand up from a chair in 30 seconds)
Time Frame
4 weeks
Title
Course of Pain
Description
measured by a diary including pain intensity on a visual analogue scale, medication
Time Frame
4 weeks
Title
Pressure pain sensitivity
Description
measured by an algometer at predefined areas
Time Frame
4 weeks
Title
Adverse events Safety measure
Description
safety measure
Time Frame
4 weeks
Title
knee function (WOMAC)
Description
physical everyday function using the validated WOMAC questionnaire
Time Frame
12 weeks
Title
measure yourself medical outcome profile (MYMOP)
Description
evaluation of symptoms and limitations
Time Frame
12 weeks
Title
Quality of Life (SF-36)
Description
health related quality of life with the validated SF-36 questionnaire
Time Frame
12 weeks
Title
self-efficacy (ASES-D)
Description
self-efficacy with the arthritis specific self efficacy scale in German
Time Frame
12 weeks
Title
Course of Pain
Description
measured by a diary including pain intensity on a visual analogue scale, medication
Time Frame
12 weeks
Title
Adverse events
Description
safety measure
Time Frame
12 weeks
Title
Pain intensity
Description
pain intensity measured on a three 0-100mmvisual analogous scales (actual, mean, worst pain)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
• Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
City
Essen
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Fenugreek Wraps in Osteoarthritis of the Knee

We'll reach out to this number within 24 hrs