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IRCT20211218053445N2 IRCT 2026-09-05 Babol University of Medical Sciences Effect of Topical Chamomile on Pain and Function in Patients with Knee Osteoarthritis Compared with Diclofenac Gel 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 2026-09-23 anticipated 72 Recruiting https://irct.ir/trial/92962 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. N/A Primary Knee Osteoarthritis. Intervention 1: Intervention group: Participants will apply the topical chamomile preparation at a dose of one fingertip unit to the affected knee every 8 hours throughout the study period. The topical chamomile preparation is formulated based on an aqueous extract of chamomile flowers and contains Carbomer 940 gel base, peppermint essential oil, propylene glycol, methylparaben, propylparaben, and triethanolamine. The preparation will be standardized based on apigenin content and subjected to microbiological quality control. Intervention 2: Control group: Participants will apply 1% diclofenac gel at a dose of one fingertip unit to the affected knee every 8 hours throughout the study period. The 1% diclofenac gel will be provided in a 60 geram tube and manufactured by Sobhan Pharmaceutical Company. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Mostafa Ahmadi
Babol University of Medical Sciences, Ganj-Afrooz. Street.
Babol Iran (Islamic Republic of) 4717647754 +98 11 3219 9592 mostafa.ahmadi.amol@gmail.com Babol University of Medical Sciences scientific Seyed Ali Mozafarpour
Babol University of Medical Sciences, Ganj-Afrooz Street.
Babol Iran (Islamic Republic of) 4717647754 +98 11 3229 9592 seyyedali1357@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Clinically confirmed primary knee osteoarthritis Knee pain Radiographic evidence of osteophytes Age of 50 years or older Morning joint stiffness lasting less than 30 minutes Crepitus during knee movement Participants with grade 1 to 3 osteophyte severity based on the Kellgren–Lawrence classification on knee radiographs. Participants with a pain intensity score of ≥3 and ≤8 on the Visual Analog Scale. 50 years 80 years Both Severe osteoarthritis Patients with impaired mobility Absence of atherosclerosis M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: Participants will apply the topical chamomile preparation at a dose of one fingertip unit to the affected knee every 8 hours throughout the study period. The topical chamomile preparation is formulated based on an aqueous extract of chamomile flowers and contains Carbomer 940 gel base, peppermint essential oil, propylene glycol, methylparaben, propylparaben, and triethanolamine. The preparation will be standardized based on apigenin content and subjected to microbiological quality control. Control group: Participants will apply 1% diclofenac gel at a dose of one fingertip unit to the affected knee every 8 hours throughout the study period. The 1% diclofenac gel will be provided in a 60 geram tube and manufactured by Sobhan Pharmaceutical Company. Change in knee pain intensity based on the Visual Analog Scale score. Timepoint: Measurement of knee pain intensity using the Visual Analog Scale at baseline, before initiation of the intervention, and at the end of each week during weeks 1 through 4 after initiation of the intervention. Method of measurement: Visual Analogue Scale. Change in knee joint symptoms. Timepoint: At baseline, before initiation of the intervention, and at the end of weeks 1, 2, 3, and 4. Method of measurement: KOOS Questionnaire. Change in physical activity. Timepoint: At baseline, before initiation of the intervention, and at the end of weeks 1, 2, 3, and 4. Method of measurement: KOOS Questionnaire. Change in sport and recreational function. Timepoint: At baseline, before initiation of the intervention, and at the end of weeks 1, 2, 3, and 4. Method of measurement: KOOS Questionnaire. Change in quality of life. Timepoint: At baseline, before initiation of the intervention, and at the end of weeks 1, 2, 3, and 4. Method of measurement: KOOS Questionnaire. Babol University of Medical Sciences Approved 2025-12-08 Research Ethics Committees of Babol University of Medical Sciences Babol Ethics Committee, Babol University of Medical Sciences, Ganj-Afrooz Street. Babol Mazandaran Iran (Islamic Republic of)