Fenugreek Wraps in Osteoarthritis of the Knee

NCT ID: NCT03528824

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-09-01

Brief Summary

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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

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fenugreek wraps

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

Group Type EXPERIMENTAL

Fenugreek wrap

Intervention Type OTHER

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

Diclofenac gel

Daily application of diclofenac gel, 4 weeks application

Group Type ACTIVE_COMPARATOR

Diclofenac Gel

Intervention Type DRUG

Daily application of diclofenac gel, 4 weeks application

Usual care

no specific intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fenugreek wrap

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

Intervention Type OTHER

Diclofenac Gel

Daily application of diclofenac gel, 4 weeks application

Intervention Type DRUG

Other Intervention Names

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Diclofenac Emulgel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Petra Klose

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Essen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BoGon

Identifier Type: -

Identifier Source: org_study_id

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