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

Phase 1 Unknown 1100 enrolled University of Monastir

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2023-07-01
Primary completion: 2024-07-31
Completion: 2024-07-31

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetaminophen	Small molecule	1 g	Oral
Comparator	Douloff	Traditional medicine (herbal / TCM)	—	Topical

Indications

No indication recorded.