NCT05647681 (DOULOFF) is a Phase 1 clinical trial of Douloff in Analgesia, sponsored by University of Monastir.

Who is sponsoring NCT05647681?

NCT05647681 is sponsored by University of Monastir.

What drugs are being tested in NCT05647681?

Interventions in NCT05647681: Douloff, paracetamol.

Is NCT05647681 still recruiting?

NCT05647681 is currently status unknown. Last updated 16 May 2023.

Last reviewed 2023-05-16 · How we verify

NCT05647681: DOULOFF

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 1 Last updated 16 May 2023

What this trial tests

Phase 1 trial testing Douloff in Analgesia in 1,100 participants. Status unknown.

Timeline

1 July 2023

Primary endpoint
31 July 2024

31 July 2024

Quick facts

Lead sponsor	University of Monastir
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,100
Start date	1 July 2023
Primary completion	31 July 2024
Estimated completion	31 July 2024

Drugs / interventions tested

Douloff — full drug profile →
paracetamol (Paracetamol) — full drug profile →

Conditions studied

Analgesia — all drugs for Analgesia →

Sponsor

University of Monastir

Who can join

Adults 18 to 60, any sex, with Analgesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy of a natural herbal topical analgesic versus oral paracetamol in patients with soft tissue injury: a randomized, double-blind, placebo-controlled study.
Toumia M, Dhaoui R, Sassi S, Kouraichi C, et al · · 2025 · PMID 40045174 · DOI 10.1093/pm/pnaf006

Verify or expand the search:

Other recruiting trials for Analgesia

Currently open trials in the same condition.

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Other University of Monastir trials

Trials by the same sponsor.

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NCT07181642 — Diaphragmatic Breathing for Sleep Bruxism in Adults: A Randomized Controlled Trial · NA · completed
NCT06980727 — Comparative Efficacy of IV Dexamethasone vs. Nebulized Salbutamol for Renal Colic Pain in the ED · Phase 3 · not yet recruiting
NCT06900972 — Effect of Colloids Versus Crystalloids on Heart Mechanics: a Double-blind Cross Over Randomized Trial · Phase 3 · enrolling by invitation
NCT06723002 — Effect of Olive Leaf Extracts on Endothelial Dysfunction in Patients With Acute Coronary Syndrome · Phase 2, PHASE3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05647681 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Monastir
Last refreshed: 16 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05647681.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing