Formulation and Evaluation of a Topical Chamomile Preparation for Reducing Pain and Improving Function in Patients with Knee Osteoarthritis Compared with Diclofenac Gel: A Double-Blind Randomized Controlled Trial

Investigating the Effect of a Topical Chamomile Preparation on Pain Reduction and Functional Improvement in Patients with Knee Osteoarthritis Compared with Diclofenac Gel

This study is a randomized, controlled, double-blind, parallel-group clinical trial involving 72 patients with primary knee osteoarthritis. Participants will be allocated at a 1:1 ratio to either the intervention group or the control group. Individual participants will be randomized using block randomization, and the allocation sequence will be generated using randomization software.

This study will be conducted as a randomized, controlled, double-blind, parallel-group clinical trial involving 72 patients with primary knee osteoarthritis at the clinics affiliated with Babol University of Medical Sciences.

Inclusion criteria: include a clinical diagnosis of primary knee osteoarthritis, knee pain, radiographic evidence of osteophytes, age ≥50 years, morning knee stiffness lasting less than 30 minutes, knee crepitus during movement, Participants with grade 1 to 3 osteophyte severity based on the Kellgren–Lawrence classification on knee radiographs, and participants with a pain intensity score of ≥3 and ≤8 on the Visual Analog Scale. Exclusion criteria: include severe osteoarthritis, limited mobility, and the absence evidence of osteoarthritis.

Participants in the intervention group will receive the topical chamomile preparation, while those in the control group will receive 1% diclofenac gel, with both treatments applied as one fingertip unit to the affected knee every 8 hours throughout the study period.

The study outcomes will include joint pain, joint stiffness, physical activity, quality of life, osteophyte severity, and treatment duration.

In this study, following confirmation of the inclusion and exclusion criteria and completion of the baseline assessment, participants will be assigned at a 1:1 ratio to one of two groups using block randomization: a group receiving a topical chamomile product and a group receiving diclofenac gel. Randomization will be performed at the individual level. Neither stratified nor quasi-randomization methods will be used. The randomization sequence will be generated using randomization software. To ensure allocation concealment, the sequence will be placed in sequentially numbered, opaque, sealed envelopes. The appropriate envelope will be opened only after completion of the baseline assessment and confirmation of the participant's eligibility and enrollment in the study.

This study will be conducted as a double-blind randomized controlled trial. Participants and outcome assessors will be blinded to group allocation. Participants will not be aware of the type of intervention they receive (topical chamomile preparation or diclofenac gel), and study outcomes, including pain and functional status, will be assessed by an individual who is unaware of participants’ group assignments. The researcher responsible for outcome assessment and data collection will also remain blinded to group allocation. Group allocation will be performed after completion of the baseline assessment and confirmation of the participant’s eligibility and enrollment. Allocation information will not be disclosed to those responsible for outcome assessment. If feasible, statistical analyses will also be performed using coded groups, with the analyst blinded to the identity of the intervention groups. All participants will provide written informed consent before enrollment after receiving a full explanation of the study objectives, procedures, potential benefits, and possible risks.

There is no further information.