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IRCT20260908070975N1 IRCT 2026-09-12 Islamic Azad University The effect of herbal ointment on delayed onset pain in athletes The effect of local induction of herbal formulation on muscle pain and muscle function after a single bout of soccer activity in male soccer players 2026-10-23 anticipated 40 Recruiting https://irct.ir/trial/93162 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible participants will be randomly allocated in a 1:1 ratio to the intervention group (herbal ointment) or the control group (placebo) after providing informed consent. The random allocation sequence will be generated using permuted random blocks with variable block sizes by a person independent of participant recruitment and outcome assessment, using random-number-generation software. The unit of randomization will be the individual participant. Allocation concealment will be ensured by using sequentially numbered, opaque, sealed envelopes containing the group codes, which will be opened only after a participant has been definitively enrolled. No stratification will be used, Blinding description: This study will be conducted as a double-blind, placebo-controlled trial. Participants will receive either the herbal ointment or a placebo ointment that is identical in appearance, color, odor, texture, packaging, and method of application. The intervention and placebo products will be labeled with anonymous codes by a person independent of participant recruitment, intervention delivery, outcome assessment, and data analysis. Participants and investigators will remain unaware of group allocation throughout the trial. Data will be analyzed using coded group labels, and the allocation code will be disclosed only after completion of the final data analysis. In the event of a serious adverse reaction requiring clinical management, the relevant allocation code may be unblinded when necessary. 1 DOMS. Intervention 1: Intervention group: The intervention group will receive a topical ointment containing mint, rosemary, thyme, and pennyroyal essential oils. The ointment will be applied topically to the target area in a standard dose and manner. Intervention 2: Control group: The control group will receive a placebo ointment with the same appearance, color, odor, texture, and packaging. The placebo will be applied in the same manner and amount as the intervention ointment.irct. Yes - There is a plan to make this available What will be shared: De-identified individual participant data, along with the study protocol, statistical analysis plan, informed consent form, final clinical study report, analysis code, and data dictionary, will be shared. When: Access will begin 6 months after publication of the final study results and will remain available for 5 years thereafter. To whom: Qualified academic researchers, faculty members, and other eligible investigators who submit a formal request. Conditions: Data may be used only for scientific analysis, reanalysis, and non-commercial research. Access is subject to confidentiality, no attempt to re-identify participants, and approval by the principal investigator. Where to obtain: Requests should be submitted to the principal investigator via email or formal correspondence. How to obtain: Requests will be reviewed, and after scientific evaluation and approval, de-identified data or documents will be provided. The usual response time is 2 to 4 weeks. Comments: Data will be provided only for scientific purposes and in accordance with research ethics principles. 12
public MOHAMAD ALI AZARBAYJANI
IRAN
Tehran Iran (Islamic Republic of) 111111111 +98 912 317 2908 ALI.AZARBAYJANI@GMAIL.COM Islamic Azad University scientific MOHAMD ALI AZARBAYJANI
IRAN
Tehran Iran (Islamic Republic of) 11111111 +98 912 317 2908 ALI.AZARBAYJANI@GMAIL.COM Islamic Azad University Iran (Islamic Republic of) Being a boy and being within the specified age range of the study Being a footballer and having a minimum amount of regular football practice experience No acute or chronic injury to the lower extremities, back, or pelvis within the past three months Not having cardiovascular, neurological, musculoskeletal, or skin diseases that affect the performance of the tests. No history of known allergies to plants, essential oils, cosmetics, or ingredients in the ointment No wounds, scratches, inflammation, infection, eczema, or skin lesions at the site of ointment application. Refrain from taking anti-inflammatory drugs, painkillers, or other recovery methods not permitted according to the research plan. 14 years 16 years Male The occurrence of any sports injury, illness, skin reaction, sensitivity, redness, itching, burning, swelling, or abnormal pain at the site of ointment application, failure to comply with research guidelines, absence from any of the assessment stages, use of medication or use of recovery methods outside the protocol, as well as the participant's personal request, will be among the exclusion criteria from the study. Despite the natural origin of the ingredients used, there is a possibility of local reactions such as redness, itching, burning, a feeling of warmth or coolness, dry skin, inflammation, swelling or allergic reactions. For this reason, an initial skin test will be performed to check the tolerance of the ointment before starting the main intervention. Rehabilitation Placebo Intervention group: The intervention group will receive a topical ointment containing mint, rosemary, thyme, and pennyroyal essential oils. The ointment will be applied topically to the target area in a standard dose and manner. Control group: The control group will receive a placebo ointment with the same appearance, color, odor, texture, and packaging. The placebo will be applied in the same manner and amount as the intervention ointment.irct Countermovement jump height in centimeters. Timepoint: Before intervention, and at 12, 36, and 60 hours after football activity. Method of measurement: Measured using the countermovement jump test and recorded as the highest jump height in centimeters. Reactive strength index. Timepoint: Before intervention, and at 12, 36, and 60 hours after football activity. Method of measurement: Measured using a jump test and calculated from jump height and ground contact time. Delayed onset muscle soreness intensity measured by visual analog scale score. Timepoint: Before intervention, and at 12, 36, and 60 hours after football activity. Method of measurement: Assessed using a visual analog scale. Mental well-being including pain, fatigue, sleep, mood, and stress. Timepoint: Before intervention, and at 12, 36, and 60 hours after football activity. Method of measurement: Assessed using a player well-being questionnaire. Islamic Azad University Approved 2026-09-07 Ethics Committee of Islamic Azad University, Tehran Central Branch NO 45,Erfaghi, sotani, tehranpars Tehran Tehran Iran (Islamic Republic of)