AnalgesiaPhase 1DOULOFFNCT05647681
Analgesic Effect of a New Analgesic Based Gel(Douloff) Versus Oral Paracetamol in Acute Soft Injuries
A Phase 1 study testing Douloff and paracetamol in people with Analgesia, run by University of Monastir.
Trial summary
Herbal medicine is commonly used to treat pain, but little is known about its effectiveness and its place in the common arsenal of analgesics .The question of whether such herbal combinations could have similar efficacy to oral analgesics in the treatment of post-traumatic soft tissue pain has not yet been… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Douloff and paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 31 Jul 2024
- Phase
- Phase 1
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients are eligible for enrollment if they are over 60 years of age, present to the emergency department with minor non-penetrating musculoskeletal soft tissue trauma occurring within 24 hours prior to admission to the emergency department, and require a prescription for home analgesic treatment at discharge: pain on movement (POM) with an intensity> 50 on a visual numeric scale (VNS) ranging from 0 to 10 (0 = no pain, 10 = maximum pain)
Who cannot join
- Patients were excluded from the study:
- If they had skin lesions (dryness or excessive redness of the skin, atopic dermatitis and eczema) in the painful area The presence of a wound, joint dislocation or multiple injuries. The presence of a fracture Patients with severe trauma (Injury Severity Score > 16) The need for hospitalization or surgery Daily use of NSAIDs or other analgesics in the 2 weeks before presentation, and previous treatment with analgesia for the same injury Contraindications to any of the drugs in the protocol, including a history of previous adverse events or a known allergy or hypersensitivity.
- Pregnant or lactating women Inability to use the VNS pain score refusal to consent or communicate
About this study
Herbal medicine is commonly used to treat pain, but little is known about its effectiveness and its place in the common arsenal of analgesics .The question of whether such herbal combinations could have similar efficacy to oral analgesics in the treatment of post-traumatic soft tissue pain has not yet been investigated. Thus, we conducted this multi-center randomized controlled trial to determine the efficacy and tolerability of a new topical herbal preparation (Douloff®) compared to oral paracetamol in the treatment of acute pain secondary to soft tissue injury.
Read the detailed description
Patients are eligible for enrollment if they are over 60 years of age, present to the emergency department with minor non-penetrating musculoskeletal soft tissue trauma occurring within 24 hours prior to admission to the emergency department, and require a prescription for home analgesic treatment at discharge: pain on movement (POM) with an intensity> 50 on a visual numeric scale (VNS) ranging from 0 to 10 (0 = no pain, 10 = maximum pain) Exclusion criteria are: skin lesions (dryness or excessive redness of the skin, atopic dermatitis and eczema) in the painful area, presence of a wound, joint dislocation or multiple injuries, fracture , patients with severe trauma (Injury Severity Score > 16), the need for hospitalization or surgery, daily use of NSAIDs or other analgesics in the 2 weeks before presentation, and previous treatment with analgesia for the same injury, Pregnant or lactating women , inability to use the VNS pain score, refusal to consent, or refusal to communicate Patients are ineligible if they have contraindications to any of the drugs in the protocol, including a history of previous adverse events or a known allergy or hypersensitivity.
Patients are randomly assigned (1:1) to receive Douloff or oral paracetamol.Randomization is performed centrally according to a computer-generated random list by a blinded research associate not involved in any other part of the trial. The subjects included are divided into two groups: the new gel (Douloff® group) or oral paracetamol (paracetamol group). All treatments in the protocol are numbered according to the randomization sequence by an independent research associate who is not involved in the monitoring or follow-up of the subjects. The topical study treatment is applied to the injured site 3 times daily for 7 days. The gel should be applied gently to the skin of the injured site for 1 minute. To minimize additional sources of response variability, adhesive and/or immobilizing casts, bandages, splints, and ice application are prohibited after randomization. Patients should be instructed to prevent water or moisture from contacting the affected area after application of topical therapy. Paracetamol is administered orally (1g three times daily).
The primary endpoint is the frequency of pain resolution defined as at least a 50% reduction in pain level (VNS) at day 7 compared with the ED discharge VNS (VNS D0) during movement (DAM).
Secondary end points included delta VNS, which is the change in VNS score from ED discharge (VNS D0) to 7 days later (VNS D7). The delta VNS is calculated as [(VNS D0 - VNS D7 / VNS D0) x 100]. Time to achieve pain resolution criteria, need for rescue analgesia, patient satisfaction, and rate of adverse events are also considered secondary endpoints. Failure to apply the gel more than three times during a treatment period constituted poor adherence.
- Conditions
- Analgesia
- Being tested
- Douloff, paracetamol
- Keywords
- analgesia,topic analgesic,herbal medicine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DouloffDrug
topic gel
paracetamolDrug
tablets
| Study group | Role | What they receive |
|---|---|---|
| topic analgesic "Douloff" | Active comparator | Patients receive a tpic analgesic "douloff" in association with an oral treatment "placebo" Receives: Drug: Douloff |
| oral paracetamol | Active comparator | Patients receive oral paracetamol in association with a topic placebo Receives: Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the frequency of pain resolution defined as at least a 50% reduction in pain level (VNS) at Day 7 compared with the ED discharge VNS (VNS Day 0) during movement (DAM)
resolution of pain with decrease of visual numeric scale (that range from 0: no pain to 10 :severe pain) more than 50% comparing to initial value
Measured: at seven days ED discharge
Secondary outcomes (5)
delta VNS, which is the change in VNS score from ED discharge (VNS D0) to 7 days later (VNS D7).
The delta VNS is calculated as [(VNS D0 - VNS D7 / VNS D0) x 100]
Measured: at seven days ED discharge
Time to achieve pain resolution
time between the start of the analgesic treatment and the one when VNS (that range from 0: no pain to 10 :severe pain) decreased to less than 3.
Measured: at seven days ED discharge
need for rescue analgesia
need for rescue analgesia
Measured: at seven days ED discharge
patient satisfaction
Satisfaction of patients evaluated with the likert score at the ED discharge.
Measured: at seven days ED discharge
adverse events rate
occurence of adverse events
Measured: at seven days ED discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jul 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multi-centre, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647681
- Sponsor's protocol ID
- Urgence Monastir
- Acronym
- DOULOFF
- Status last verified
- May 2023
- First submitted
- 3 Dec 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Toumia M, Dhaoui R, Sassi S, Kouraichi C, Bel Haj Ali K, Sekma A, Bakir A, Jaballah R, Yaakoubi H, Youssef R, Zorgati A, Beltaief K, Mezgar Z, Khrouf M, Sghaier A, Jerbi N, Zemni I, Bouida W, Grissa MH, Saad J, Boubaker H, Boukef R, Msolli MA, Nouira S. Efficacy of a natural herbal topical analgesic versus oral paracetamol in patients with soft tissue injury: a randomized, double-blind, placebo-controlled study. Pain Med. 2025 Jun 1;26(6):329-336. doi: 10.1093/pm/pnaf006.
PubMed 40045174
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of a New Analgesic Based Gel(Douloff) Versus Oral Paracetamol in Acute Soft Injuries
- ClinicalTrials.gov ID
- NCT05647681
- Acronym / sponsor ID
- DOULOFF / Urgence Monastir
- Conditions
- Analgesia
- Keywords
- analgesia,topic analgesic,herbal medicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 12 Dec 2022 (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.
Herbal medicine is commonly used to treat pain, but little is known about its effectiveness and its place in the common arsenal of analgesics .The question of whether such herbal combinations could have similar efficacy to oral analgesics in the treatment of post-traumatic soft tissue pain has not yet been investigated. Thus, we conducted this multi-center randomized controlled trial to determine the efficacy and tolerability of a new topical herbal preparation (Douloff®) compared to oral paracetamol in the treatment of acute pain secondary to soft tissue injury.
Detailed description
Patients are eligible for enrollment if they are over 60 years of age, present to the emergency department with minor non-penetrating musculoskeletal soft tissue trauma occurring within 24 hours prior to admission to the emergency department, and require a prescription for home analgesic treatment at discharge: pain on movement (POM) with an intensity> 50 on a visual numeric scale (VNS) ranging from 0 to 10 (0 = no pain, 10 = maximum pain) Exclusion criteria are: skin lesions (dryness or excessive redness of the skin, atopic dermatitis and eczema) in the painful area, presence of a wound, joint dislocation or multiple injuries, fracture , patients with severe trauma (Injury Severity Score > 16), the need for hospitalization or surgery, daily use of NSAIDs or other analgesics in the 2 weeks before presentation, and previous treatment with analgesia for the same injury, Pregnant or lactating women , inability to use the VNS pain score, refusal to consent, or refusal to communicate Patients are ineligible if they have contraindications to any of the drugs in the protocol, including a history of previous adverse events or a known allergy or hypersensitivity.
Patients are randomly assigned (1:1) to receive Douloff or oral paracetamol.Randomization is performed centrally according to a computer-generated random list by a blinded research associate not involved in any other part of the trial. The subjects included are divided into two groups: the new gel (Douloff® group) or oral paracetamol (paracetamol group). All treatments in the protocol are numbered according to the randomization sequence by an independent research associate who is not involved in the monitoring or follow-up of the subjects. The topical study treatment is applied to the injured site 3 times daily for 7 days. The gel should be applied gently to the skin of the injured site for 1 minute. To minimize additional sources of response variability, adhesive and/or immobilizing casts, bandages, splints, and ice application are prohibited after randomization. Patients should be instructed to prevent water or moisture from contacting the affected area after application of topical therapy. Paracetamol is administered orally (1g three times daily).
The primary endpoint is the frequency of pain resolution defined as at least a 50% reduction in pain level (VNS) at day 7 compared with the ED discharge VNS (VNS D0) during movement (DAM).
Secondary end points included delta VNS, which is the change in VNS score from ED discharge (VNS D0) to 7 days later (VNS D7). The delta VNS is calculated as [(VNS D0 - VNS D7 / VNS D0) x 100]. Time to achieve pain resolution criteria, need for rescue analgesia, patient satisfaction, and rate of adverse events are also considered secondary endpoints. Failure to apply the gel more than three times during a treatment period constituted poor adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- multi-centre, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| topic analgesic "Douloff" | Active comparator | Drug: DouloffPatients receive a tpic analgesic "douloff" in association with an oral treatment "placebo" |
| oral paracetamol | Active comparator | Drug: paracetamolPatients receive oral paracetamol in association with a topic placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients are eligible for enrollment if they are over 60 years of age, present to the emergency department with minor non-penetrating musculoskeletal soft tissue trauma occurring within 24 hours prior to admission to the emergency department, and require a prescription for home analgesic treatment at discharge: pain on movement (POM) with an intensity> 50 on a visual numeric scale (VNS) ranging from 0 to 10 (0 = no pain, 10 = maximum pain)
Key exclusion criteria (3 listed)
- Patients were excluded from the study:
- If they had skin lesions (dryness or excessive redness of the skin, atopic dermatitis and eczema) in the painful area The presence of a wound, joint dislocation or multiple injuries. The presence of a fracture Patients with severe trauma (Injury Severity Score > 16) The need for hospitalization or surgery Daily use of NSAIDs or other analgesics in the 2 weeks before presentation, and previous treatment with analgesia for the same injury Contraindications to any of the drugs in the protocol, including a history of previous adverse events or a known allergy or hypersensitivity.
- Pregnant or lactating women Inability to use the VNS pain score refusal to consent or communicate
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 |
|---|---|---|
| Doulofftopic gel | Drug | topic analgesic "Douloff" |
| paracetamoltablets | Drug | oral paracetamol |
Primary outcome
the frequency of pain resolution defined as at least a 50% reduction in pain level (VNS) at Day 7 compared with the ED discharge VNS (VNS Day 0) during movement (DAM)
Time frame: at seven days ED discharge
resolution of pain with decrease of visual numeric scale (that range from 0: no pain to 10 :severe pain) more than 50% comparing to initial value
5 secondary outcomes
delta VNS, which is the change in VNS score from ED discharge (VNS D0) to 7 days later (VNS D7).
Time frame: at seven days ED discharge
Time to achieve pain resolution
Time frame: at seven days ED discharge
need for rescue analgesia
Time frame: at seven days ED discharge
patient satisfaction
Time frame: at seven days ED discharge
adverse events rate
Time frame: at seven days ED discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 40045174Toumia M, Dhaoui R, Sassi S, Kouraichi C, Bel Haj Ali K, Sekma A, Bakir A, Jaballah R, Yaakoubi H, Youssef R, Zorgati A, Beltaief K, Mezgar Z, Khrouf M, Sghaier A, Jerbi N, Zemni I, Bouida W, Grissa MH, Saad J, Boubaker H, Boukef R, Msolli MA, Nouira S. Efficacy of a natural herbal topical analgesic versus oral paracetamol in patients with soft tissue injury: a randomized, double-blind, placebo-controlled study. Pain Med. 2025 Jun 1;26(6):329-336. doi: 10.1093/pm/pnaf006.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Douloff and paracetamol in people with Analgesia, run by University of Monastir.
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 1 inclusion and 3 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 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
the frequency of pain resolution defined as at least a 50% reduction in pain level (VNS) at Day 7 compared with the ED discharge VNS (VNS Day 0) during movement (DAM) (time frame: at seven days ED discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647681, which also lists 1 linked publication.
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 16 May 2023.