Fenugreek Wraps in Osteoarthritis of the Knee

Osteoarthritis, Knee Clinical Trial

— BoGon  

Official title:

Randomised Controlled Trial on the Efficacy of Fenugreek Wraps in Symptomatic Primary Gonarthrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528824
• Other study ID #: BoGon
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: October 2021
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Germany	• Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	pain intensity measured on three 0-100mm visual analogous scales (actual, mean, worst pain)	4 weeks
Secondary	knee function (WOMAC)	physical everyday function using the validated WOMAC questionnaire	4 weeks
Secondary	measure yourself medical outcome profile (MYMOP)	evaluation of symptoms and limitations	4 weeks
Secondary	Quality of Life (SF-36)	health related quality of life with the validated SF-36 questionnaire	4 weeks
Secondary	self-efficacy (ASES-D)	self-efficacy with the arthritis specific self efficacy scale in German	4 weeks
Secondary	physical function (30second chair test)	validated test to measure how often patients can stand up from a chair in 30 seconds)	4 weeks
Secondary	Course of Pain	measured by a diary including pain intensity on a visual analogue scale, medication	4 weeks
Secondary	Pressure pain sensitivity	measured by an algometer at predefined areas	4 weeks
Secondary	Adverse events Safety measure	safety measure	4 weeks
Secondary	knee function (WOMAC)	physical everyday function using the validated WOMAC questionnaire	12 weeks
Secondary	measure yourself medical outcome profile (MYMOP)	evaluation of symptoms and limitations	12 weeks
Secondary	Quality of Life (SF-36)	health related quality of life with the validated SF-36 questionnaire	12 weeks
Secondary	self-efficacy (ASES-D)	self-efficacy with the arthritis specific self efficacy scale in German	12 weeks
Secondary	Course of Pain	measured by a diary including pain intensity on a visual analogue scale, medication	12 weeks
Secondary	Adverse events	safety measure	12 weeks
Secondary	Pain intensity	pain intensity measured on a three 0-100mmvisual analogous scales (actual, mean, worst pain)	12 weeks