Analgesic Effect of a New Analgesic Based Gel(Douloff) Versus Oral Paracetamol in Acute Soft Injuries

NCT05647681 | Unknown Phase 1 DMC

• 1 other identifier: Urgence Monastir
• Study Type: interventional
• Target: 1,100
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Analgesia

Keywords

analgesia,topic analgesic,herbal medicine

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  at seven days ED discharge

• Time to achieve pain resolution

  at seven days ED discharge

• need for rescue analgesia

  at seven days ED discharge

• patient satisfaction

  at seven days ED discharge

• adverse events rate

  at seven days ED discharge

Study Arms (2)

topic analgesic "Douloff"

ACTIVE COMPARATOR

Patients receive a tpic analgesic "douloff" in association with an oral treatment "placebo"

Drug: Douloff

oral paracetamol

ACTIVE COMPARATOR

Patients receive oral paracetamol in association with a topic placebo

Drug: paracetamol

Interventions

Douloff DRUG

topic gel

topic analgesic "Douloff"

paracetamol DRUG

tablets

oral paracetamol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

Related Publications (1)

• 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.

  PMID: 40045174 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients are randomly assigned to receive a topic analgesic "Douloff" or palcebo associated with an oral treatment "Paracetamol" or placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Model Details: multi-centre, randomized controlled trial

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: December 12, 2022
• Study Start: July 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05