Fenugreek Wraps in Osteoarthritis of the Knee
BoGon
Randomised Controlled Trial on the Efficacy of Fenugreek Wraps in Symptomatic Primary Gonarthrosis
1 other identifier
interventional
81
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2018
CompletedFirst Posted
Study publicly available on registry
May 18, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedOctober 6, 2021
October 1, 2021
2.2 years
May 6, 2018
October 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Pain intensity
pain intensity measured on three 0-100mm visual analogous scales (actual, mean, worst pain)
4 weeks
Secondary Outcomes (15)
knee function (WOMAC)
4 weeks
measure yourself medical outcome profile (MYMOP)
4 weeks
Quality of Life (SF-36)
4 weeks
self-efficacy (ASES-D)
4 weeks
physical function (30second chair test)
4 weeks
- +10 more secondary outcomes
Study Arms (3)
Fenugreek wraps
EXPERIMENTALDaily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application
Diclofenac gel
ACTIVE COMPARATORDaily application of diclofenac gel, 4 weeks application
Usual care
NO INTERVENTIONno specific intervention
Interventions
Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application
Daily application of diclofenac gel, 4 weeks application
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
• Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Essen, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 6, 2018
First Posted
May 18, 2018
Study Start
June 1, 2018
Primary Completion
August 1, 2020
Study Completion
September 1, 2020
Last Updated
October 6, 2021
Record last verified: 2021-10