PainEVAPURGELNCT04736563
Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel on Joint Pain of the Knee
A study testing Joint and muscle gel Puressentiel in people with Pain and Joint Pain, run by Marco Pacchioni at 1 site in France.
Trial summary
This clinical trial aims to evaluate the antalgic effect of Puressentiel Joints and Muscles - Gel with 14 essential oils for 12 weeks on knee joint pain in 45 patients suffering from chronic pain related to arthritis of the knee. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Pain, Joint Pain
- What is being tested?
- Joint and muscle gel Puressentiel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 30 Jun 2021
- 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject smust be able to understand the terms of the written informed consent and must agree to date and sign it before any study procedure is carried out,
- Patient having signed the informed consent
- Aged 45 to 90
- With chronic osteoarthritis of the knee
- Patient with or without analgesic and anti-inflammatory treatment
Who cannot join
- Patient at the stage of surgical osteoarthritis (grade 4 plus limitation of amplitude)
- Patient with a limited walking perimeter (<100m) for any reason whatsoever
- Patient allergic to one of the components of the study product
- Patient not benefiting from social security
- Patient cannot be followed for the duration of the study
- Participation in another clinical trial within 30 days before V0
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- Subjects who cannot understand or perform study procedures.
- Pregnant or breastfeeding women
- People with a history of convulsive or epileptic disorders
- People allergic to salicylates.
Trial locations and contacts
1 site in 1 country.
Elisabeth Simon contact
About this study
Official title: Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel with14 Essential Oils on Joint Pain of the Knee
This clinical trial aims to evaluate the antalgic effect of Puressentiel Joints and Muscles - Gel with 14 essential oils for 12 weeks on knee joint pain in 45 patients suffering from chronic pain related to arthritis of the knee. The evaluation of the puressentiel antalgic effect Joints and Muscles - Gel with 14 essential oils will be done by an algo-functional score of WOMAC based on items of pain, joint stiffness and locomotor function (main criterion), a visual analog scale EVA (graduated from 1 to 10) of the pain by self-assessment of the patient during the consultation and the number of daily analgesics and anti-inflammatory drugs (secondary criteria).
Read the detailed description
This clinical trial aims to evaluate the antalgic effect of Puressentiel Joints and Muscles - Gel with 14 essential oils for 12 weeks on knee joint pain in 45 patients suffering from chronic pain related to arthritis of the knee. The patients included in the study will be consultants from the Department of Physical Medicine, Rehabilitation and Sports Trauma at Foch Hospital in Suresnes and will have to present chronic pain related to arthritis of the knee either with or without antalgic and anti-inflammatory treatment. The evaluation of the puressentiel antalgic effect Joints and Muscles - Gel with 14 essential oils will be evaluated by an algo-functional score of WOMAC based on items of pain, joint stiffness and locomotor function (main criterion), a visual analog scale EVA (graduated from 1 to 10) of the pain by self-assessment of the patient during each visit and the number of daily antalgic and anti-inflammatory drugs (secondary criteria).
- Conditions
- Pain, Joint Pain
- Being tested
- Joint and muscle gel Puressentiel
- Keywords
- Pain, Arthritis, Knee
- Medical subject headings
- Pain, Arthralgia, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint and muscle gel PuressentielDevice
To evaluate the antalgic effect in patients with chronic pain related to osteoarthritis of the knee when applied to the skin of Puressentiel Joints and Muscles - Gel with 14 essential oils.
| Study group | Role | What they receive |
|---|---|---|
| patients with painful arthritis of the knee | Experimental | Administration of joints and muscle gel Puressentiel containing of 14 essential oils Receives: Device: Joint and muscle gel Puressentiel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Womac score is the primary outcome
Scoring pain and locomotion with a maximum score (worse of 96). A change of 16 points is considered as a significant clinical improvement
Measured: 30 days
Pain visual analog analog scale is the secondary outcome
Scoring pain from 1 to 100 (worse)
Measured: 30 days
Secondary outcomes (1)
Pain visual analog scale
Pain visual analog scale scored from 0 to 100(worse). A change of 10 points is considered as clinically significant
Measured: Evaluation at inclusion and after 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Feb 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- open single arm study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marco Pacchioni
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Marco Pacchioni, Puressentiel
- Investigators
- Elisabeth Simon, Pharm Dr, Study director, Puressentiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736563
- Sponsor's protocol ID
- Puressentiel laboratory
- Acronym
- EVAPURGEL
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2021
- Last updated
- 10 Feb 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 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel with14 Essential Oils on Joint Pain of the Knee
- ClinicalTrials.gov ID
- NCT04736563
- Acronym / sponsor ID
- EVAPURGEL / Puressentiel laboratory
- Conditions
- Pain, Joint Pain
- Keywords
- Pain, Arthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marco PacchioniIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 3 Feb 2021 (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 clinical trial aims to evaluate the antalgic effect of Puressentiel Joints and Muscles - Gel with 14 essential oils for 12 weeks on knee joint pain in 45 patients suffering from chronic pain related to arthritis of the knee. The evaluation of the puressentiel antalgic effect Joints and Muscles - Gel with 14 essential oils will be done by an algo-functional score of WOMAC based on items of pain, joint stiffness and locomotor function (main criterion), a visual analog scale EVA (graduated from 1 to 10) of the pain by self-assessment of the patient during the consultation and the number of daily analgesics and anti-inflammatory drugs (secondary criteria).
Detailed description
This clinical trial aims to evaluate the antalgic effect of Puressentiel Joints and Muscles - Gel with 14 essential oils for 12 weeks on knee joint pain in 45 patients suffering from chronic pain related to arthritis of the knee. The patients included in the study will be consultants from the Department of Physical Medicine, Rehabilitation and Sports Trauma at Foch Hospital in Suresnes and will have to present chronic pain related to arthritis of the knee either with or without antalgic and anti-inflammatory treatment. The evaluation of the puressentiel antalgic effect Joints and Muscles - Gel with 14 essential oils will be evaluated by an algo-functional score of WOMAC based on items of pain, joint stiffness and locomotor function (main criterion), a visual analog scale EVA (graduated from 1 to 10) of the pain by self-assessment of the patient during each visit and the number of daily antalgic and anti-inflammatory drugs (secondary criteria).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open single arm study
| Arm | Type | Receives |
|---|---|---|
| patients with painful arthritis of the knee | Experimental | Device: Joint and muscle gel PuressentielAdministration of joints and muscle gel Puressentiel containing of 14 essential oils |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject smust be able to understand the terms of the written informed consent and must agree to date and sign it before any study procedure is carried out,
- Patient having signed the informed consent
- Aged 45 to 90
- With chronic osteoarthritis of the knee
- Patient with or without analgesic and anti-inflammatory treatment
Key exclusion criteria (10 listed)
- Patient at the stage of surgical osteoarthritis (grade 4 plus limitation of amplitude)
- Patient with a limited walking perimeter (<100m) for any reason whatsoever
- Patient allergic to one of the components of the study product
- Patient not benefiting from social security
- Patient cannot be followed for the duration of the study
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 |
|---|---|---|
| Joint and muscle gel PuressentielTo evaluate the antalgic effect in patients with chronic pain related to osteoarthritis of the knee when applied to the skin of Puressentiel Joints and Muscles - Gel with 14 essential oils. | Device | patients with painful arthritis of the knee |
Primary outcome
Womac score is the primary outcome
Time frame: 30 days
Scoring pain and locomotion with a maximum score (worse of 96). A change of 16 points is considered as a significant clinical improvement
Pain visual analog analog scale is the secondary outcome
Time frame: 30 days
Scoring pain from 1 to 100 (worse)
1 secondary outcome
Pain visual analog scale
Time frame: Evaluation at inclusion and after 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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.
Elisabeth Simon contact
Elisabeth Simon, Pharm Dr study director
Puressentiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint and muscle gel Puressentiel in people with Pain and Joint Pain, run by Marco Pacchioni at 1 site in France.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 10 Feb 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Simon, MD (33611815878, n.barizien@hopital-foch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Womac score is the primary outcome (time frame: 30 days). The study lists 2 primary outcomes in all. 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 10 Feb 2021.