Condition category
Musculoskeletal Diseases
Date applied
29/01/2016
Date assigned
09/02/2016
Last edited
09/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Harpagophytum Procumbens (commonly known as devil’s claw) is a plant that originates from southern Africa. It’s roots are used to reduce pain and fever. The chemicals thought to be responsible for the plants pain killing properties are Harpagoside, Harpagide and Procumbide. This study is testing the pain relieving properties of a cream containing Harpagophytum Procumbens in people suffering from knee pain caused by osteoarthritis.

Who can participate?
Adults suffering from osteoarthritis of the knee.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are given a harpagophytum containing cream to apply to their knee. Those in group 2 are given a placebo cream that looks and feels like the harpagophytum containing cream to apply to their knee. All participants assess for themselves the amount of pain they are feeling before and after they have put on the cream.

What are the possible benefits and risks of participating?
There are no risks to participating in this study as the ingredients of the cream are absolutely free of any possible adverse effects.

Where is the study run from?
A number of orthopedic private practices in Thessaloniki and Volos (Greece)

When is the study starting and how long is it expected to run for?
February 2016 to August 2016

Who is funding the study?
Synapse Hellenic Pharmaceuticals & Services

Who is the main contact?
Dr Eleftherios Teperikidis

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eleftherios Teperikidis

ORCID ID

Contact details

Egnatias 117
Thessaloniki
54635
Greece

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effectiveness of harpagophytum procumbens cream in the relief of osteoarthritic pain of the knee: a double blind, placebo controlled, randomised interventional study

Acronym

HARPAIN TRIAL

Study hypothesis

The hypothesis of the study is that harpagophytum Procumbens cream is better than placebo in the relief of osteoarthritic knee pain.

Ethics approval

Not provided at time of registration

Study design

Double blind, placebo controlled, randomised interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Osteoarthritis of the knee

Intervention

Patients who meet the radiographic inclusion criteria will be asked to initially evaluate the level of their pain in the knee on a Visual Analogue Scale (0 – 10). Based on the V.A.S scale result and the level of osteoarthritis it is decided by the researcher whether the inclusion criteria are met. All patients will be asked to sign a patient release form before participating in the trial. Patients will then be randomly assigned to either treatment or placebo group.

In the treatment group, 3 mL of a harpagophytum containing cream will be applied on the affected knee. The placebo group will receive 3 mL of a cream that has been designed to have the same color, smell and texture as the active cream.

Ten minutes after the application of the cream, patients will be asked to evaluate the level of the pain that they feel on a Visual Analogue Scale (0 – 10), as well as if they experience any adverse effect (skin reaction etc.). Through the ten minute waiting period, the researcher will complete the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), an established and accredited questionnaire used in high quality clinical trials, evaluating the problems caused by Osteoarthritis in patient’s every day life.

At the end of the study all researchers will fill out a questionnaire regarding the execution of the trial as per the instructions given.

Intervention type

Drug

Phase

Drug names

Harpagophytum procumbens

Primary outcome measures

Patient improvement on pain as evaluated by a Visual Analogue Scale (0-10) ten minutes after application of the cream.

Secondary outcome measures

N/A

Overall trial start date

01/02/2016

Overall trial end date

01/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Osteoarthritis Stage (Kellgren & Lawrence Scale) 2 - 3
2. Patient’s Knee - Pain Self Evaluation (VAS 0 - 10) 4, 5, 6, 7

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Osteoarthritis Stage (Kellgren & Lawrence Scale) 0, 1, 4
2. Patient’s Knee- Pain Self Evaluation (VAS 0 - 10) 0 – 3 , 8 - 10
3. Use of analgesic or anti-inflammatory medications, topical or oral on the day of the study

Recruitment start date

01/02/2016

Recruitment end date

01/08/2016

Locations

Countries of recruitment

Greece

Trial participating centre

Number of orthopedic private practices
Thessaloniki and Volos
54635
Greece

Sponsor information

Organisation

Synapse Hellenic Pharmaceuticals & Services

Sponsor details

Egnatias 117
Thessaloniki
54635
Greece

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Synapse Hellenic Pharmaceuticals & Services

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

01/08/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes