Osteoarthritis, KneeBoGonNCT03528824
Fenugreek Wraps in Osteoarthritis of the Knee
A study testing Fenugreek wrap and Diclofenac Gel in people with Osteoarthritis, Knee, run by Universität Duisburg-Essen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Fenugreek wrap and Diclofenac Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2018to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 9Show fewer
- participation in other studies, regarding gonarthrosis
- asthma
- pregnancy, breastfeeding
Trial locations and contacts
1 site in 1 country.
Germany1 site
• Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Essen
About this study
Official title: Randomised Controlled Trial on the Efficacy of Fenugreek Wraps in Symptomatic Primary Gonarthrosis
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Fenugreek wrap, Diclofenac Gel
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenugreek wrapOther
Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application
Diclofenac GelDrug
Also called Diclofenac Emulgel
Daily application of diclofenac gel, 4 weeks application
| Study group | Role | What they receive |
|---|---|---|
| Fenugreek wraps | Experimental | Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application Receives: Other: Fenugreek wrap |
| Diclofenac gel | Active comparator | Daily application of diclofenac gel, 4 weeks application Receives: Drug: Diclofenac Gel |
| Usual care | No intervention | no specific intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
pain intensity measured on three 0-100mm visual analogous scales (actual, mean, worst pain)
Measured: 4 weeks
Secondary outcomes (15)
knee function (WOMAC)
physical everyday function using the validated WOMAC questionnaire
Measured: 4 weeks
measure yourself medical outcome profile (MYMOP)
evaluation of symptoms and limitations
Measured: 4 weeks
Quality of Life (SF-36)
health related quality of life with the validated SF-36 questionnaire
Measured: 4 weeks
self-efficacy (ASES-D)
self-efficacy with the arthritis specific self efficacy scale in German
Measured: 4 weeks
physical function (30second chair test)
validated test to measure how often patients can stand up from a chair in 30 seconds)
Measured: 4 weeks
Course of Pain
measured by a diary including pain intensity on a visual analogue scale, medication
Measured: 4 weeks
Pressure pain sensitivity
measured by an algometer at predefined areas
Measured: 4 weeks
Adverse events Safety measure
safety measure
Measured: 4 weeks
knee function (WOMAC)
physical everyday function using the validated WOMAC questionnaire
Measured: 12 weeks
measure yourself medical outcome profile (MYMOP)
evaluation of symptoms and limitations
Measured: 12 weeks
Quality of Life (SF-36)
health related quality of life with the validated SF-36 questionnaire
Measured: 12 weeks
self-efficacy (ASES-D)
self-efficacy with the arthritis specific self efficacy scale in German
Measured: 12 weeks
Course of Pain
measured by a diary including pain intensity on a visual analogue scale, medication
Measured: 12 weeks
Adverse events
safety measure
Measured: 12 weeks
Pain intensity
pain intensity measured on a three 0-100mmvisual analogous scales (actual, mean, worst pain)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start1 Jun 2018
- Primary completion1 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petra Klose, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528824
- Sponsor's protocol ID
- BoGon
- Acronym
- BoGon
- Status last verified
- Oct 2021
- First submitted
- 6 May 2018
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial on the Efficacy of Fenugreek Wraps in Symptomatic Primary Gonarthrosis
- ClinicalTrials.gov ID
- NCT03528824
- Acronym / sponsor ID
- BoGon / BoGon
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fenugreek wraps | Experimental | Other: Fenugreek wrapDaily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application |
| Diclofenac gel | Active comparator | Drug: Diclofenac GelDaily application of diclofenac gel, 4 weeks application |
| Usual care | No intervention | –no specific intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenugreek wrapDaily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application | Other | Fenugreek wraps |
| Diclofenac GelAlso: Diclofenac EmulgelDaily application of diclofenac gel, 4 weeks application | Drug | Diclofenac gel |
Primary outcome
Pain intensity
Time frame: 4 weeks
pain intensity measured on three 0-100mm visual analogous scales (actual, mean, worst pain)
15 secondary outcomes
knee function (WOMAC)
Time frame: 4 weeks
measure yourself medical outcome profile (MYMOP)
Time frame: 4 weeks
Quality of Life (SF-36)
Time frame: 4 weeks
self-efficacy (ASES-D)
Time frame: 4 weeks
physical function (30second chair test)
Time frame: 4 weeks
Course of Pain
Time frame: 4 weeks
Pressure pain sensitivity
Time frame: 4 weeks
Adverse events Safety measure
Time frame: 4 weeks
knee function (WOMAC)
Time frame: 12 weeks
measure yourself medical outcome profile (MYMOP)
Time frame: 12 weeks
Quality of Life (SF-36)
Time frame: 12 weeks
self-efficacy (ASES-D)
Time frame: 12 weeks
Course of Pain
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Pain intensity
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fenugreek wrap and Diclofenac Gel in people with Osteoarthritis, Knee, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.