comparison of the effectiveness of a Topical Cream (DEMUlcent ™) Containing Arnica and Rosemary Extracts with Diclofenac 1% on improvement of pain in patients with knee joint osteoarthritis: A randomized Double-blind Control Trial

comparison pain relief between the DEMUlcent and Diclofenac group

This double-blind, comparative, parallel and randomized clinical trial. Evaluate the effectiveness of topical demulcent cream with diclofenac 1% gel in pain relief on 284 patients. Excel software is used for randomization.

After obtaining the clinical trial code, the study entered the implementation stage and was carried out at Loghman Hakim Hospital under the supervision of 2 professors of Shahid Beheshti University of Medical Sciences with the help of a nurse and a statistical consultant.

inclusion criteria include: Patients (both male and female) with knee osteoarthritis (OA) are treated in Loghman Hakim hospital, aged 38 to 65 years old, Kellgren-Lowrence grade 1-3, and numerical rating score (NRS) knee joint pain between 5 to 9 were enrolled in the study if they had standing knee X-ray / Patients were excluded if they: a) were pregnant or lactating; b) had secondary arthritis related to syphilitic neuropathy, ochronosis, psoriasis, metabolic bone disease, or acute trauma; c) chondrocalcinosis with a history of pseudogout; fibromyalgia; d) had rheumatoid arthritis (RA); e) had chronic inflammatory disease such as colitis, current GI bleeding q) had received NSAIDs, anti-inflammatory treatment including oral or topical forms;

Intervention group: DEMUlcent La' farrerr Cream in a white and unspecified Tube/Used for 28 days, Every 8 Hours at pain site and around category: Treatment - Drugs Control group: Diclofenac 1% gel in a White and Unspecified Tube/Used for 28days, every 8 hours at pain location and around of it category: Treatment - Drugs

visual analogue scale (VAS) for self-reporting of their knee joint pain. Evaluating pain, stiffness, and physical function by WOMAC questionnaire.

The patients that met eligibility criteria were randomly assigned to either the intervention and control group using a block size of 4. in each of the two intervention groups, the participants are divided into randomized blocks. when the patients go to the hospital, depending on the randomized process, they have received each intervention with specific number on it.

For blinding, both intervention was packed with an identical tube with a same appearance labeled with an identification number. during study, neither the researchers nor the physicians had access to the randomization list and were kept unable to predict the allocation.