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IRCT20250720066574N1 IRCT 2025-08-28 Islamic Azad University Investigation of the Effect of Achillea millefolium and Tanacetum Oils in Cream Form on Musculoskeletal Pain AMTO-Pain A Randomized Controlled Trial to Evaluate the Effect of a Topical Cream Containing Achillea millefolium and Tanacetum Oils on Musculoskeletal Pain in Adults: Comparison with Placebo 2025-10-23 anticipated 120 Complete https://irct.ir/trial/85353 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization will be performed using permuted block randomization with variable block sizes (4 and 6) to maintain balance in the number of participants allocated to the two groups: the intervention group (topical cream containing Achillea millefolium and Melissa officinalis oils) and the control group (placebo cream). Unit of randomization: Individual (each participant will be independently assigned to one of the two groups). Stratification: Randomization will be stratified by sex (male/female) and pain status (acute/chronic) to ensure balanced distribution of these variables between groups. Random sequence generation tool: The allocation sequence will be generated by an independent statistician using statistical software (e.g., R or Stata). Within each stratum, blocks of variable sizes will be randomly arranged. Sequence generation and storage: The final allocation sequence will be stored in an encrypted file and managed by a person not involved in participant recruitment or outcome assessment (statistician or study pharmacist). Allocation concealment: To prevent selection bias, Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) or a centralized randomization system will be used. The recruiter will open the next envelope or obtain the allocation code from the system only after confirming eligibility of the participant. Blinding: The intervention and placebo creams will be identical in appearance, packaging, labeling, and texture, and will only be distinguished by code. Thus, participants, clinical investigators, and outcome assessors will remain blinded to group allocation. Code breaking (Unblinding): Unblinding will only be permissible in case of a medical emergency and must be fully documented. After data collection is completed and the database is locked, codes will be released by the independent statistician. Quasi-randomization: No quasi-random methods (such as allocation by date of birth or order of recruitment) will be used in this study, Blinding description: This study will be conducted as a double-blind randomized controlled trial. Both participants and investigators responsible for administering the intervention and assessing outcomes will be blinded to group allocation. The creams for intervention and placebo will be identical in appearance, texture, and packaging to maintain blinding. Data analysts will also be blinded during data analysis to prevent bias. Allocation concealment will be ensured using sealed, opaque envelopes. The Data Safety Monitoring Board, if involved, will have access to unblinded data only when necessary for safety assessments. 2-3 Condition 1: Myositis. Condition 2: Polyarthrosis. Condition 3: Coxarthrosis [arthrosis of hip]. Condition 4: Osteoarthritis of knee. Condition 5: Osteoarthritis of first carpometacarpal joint. Condition 6: Other and unspecified osteoarthritis. Condition 7: Calcification and ossification of muscle. Condition 8: Other disorders of muscle. Condition 9: Disorders of muscle in diseases classified elsewhere. Condition 10: Rheumatoid arthritis with rheumatoid factor. Condition 11: Other rheumatoid arthritis. Condition 12: Enteropathic arthropathies. Condition 13: Juvenile arthritis. Condition 14: Gout. Condition 15: Other crystal arthropathies. Condition 16: Other and unspecified arthropathy. Condition 17: Other arthritis. Intervention 1: Intervention group: recipients of a topical cream containing therapeutic oils extracted from Achillea millefolium (yarrow) and Tanacetum (tansy) plants.Usage: topical application on the painful area with gentle massage.Frequency: once to twice daily.Duration: at least 2 weeks and up to 4 weeks (depending on pain severity).Preparation: the cream is prepared by a licensed pharmacist in a pharmacy, free of unnecessary chemical additives, and is delivered to the patient at the clinic. Intervention 2: Control group: recipients of a topical cream with the same appearance, color, smell, and texture as the herbal cream but without active therapeutic ingredients (i.e., free of Achillea millefolium and Tanacetum oils).Usage, dosage, and duration are the same as the intervention group.The purpose of this group is to control for the psychological (placebo) effect of the treatment. Yes - There is a plan to make this available What will be shared: The study data include de-identified participant information regarding pain intensity (based on the VAS scale), motor function (responses to standardized questionnaires), and other clinical outcome-related data. These data were collected to evaluate the efficacy of the herbal cream in reducing musculoskeletal pain and improving motor function, and will be shared as structured electronic files. When: The data will be available from the time of study publication and will remain accessible to researchers for up to 5 years thereafter. Bahar Darou Mehr Company may also request the publication of an article based on the study results. To whom: Researchers affiliated with academic, research, and other recognized scientific institutions who submit a formal request will be granted access to the data and documents. Access for individuals from industry or commercial sectors will be considered only upon ethical and scientific review and approval. Conditions: The data and documents may only be used for research, educational, or secondary analysis purposes. Usage must comply with research ethics principles, participant confidentiality, and data protection regulations. Any commercial use or public dissemination without written permission from the research team is strictly prohibited. Applicants must submit a research proposal and sign a data use agreement ensuring responsible and restricted use. Where to obtain: Applicants can contact the principal investigator via email or phone to request access to the study data or documents. How to obtain: After receiving the request via email or phone, the principal investigator will review the research purpose and the applicant’s affiliation. If the request is deemed appropriate, a data-sharing agreement will be signed. Upon completion of the agreement, the requested de-identified data or documents will be provided within 2 to 4 weeks. Comments:
public Ali Aghababai Beni
Rahmatiyeh
Shahrekord Iran (Islamic Republic of) 8813733395 +98 38 3336 1000 aliaghababai@yahoo.com Islamic Azad University scientific Ali Aghababai Beni
Rahmatiyeh
Shahrekord Iran (Islamic Republic of) 8813733395 +98 38 3336 1000 ali.aghababai@iau.ir Islamic Azad University Iran (Islamic Republic of) Having mild to moderate musculoskeletal pain (involving areas such as the lower back, neck, knee, shoulder, joints, or muscles), with a pain score between 3 and 7 on the Visual Analog Scale (VAS) Stable musculoskeletal pain for at least the past two weeks No use of topical or oral analgesic medications or supplements within the past 72 hours Written informed consent to participate in the study Ability to comply with study procedures (completing forms, regular use of the cream, and attending follow-up visits) No known hypersensitivity or history of allergy to herbal components or topical products no limit no limit Both Known allergy or hypersensitivity to medicinal herbs or essential oils Presence of dermatological conditions at the site of cream application Use of topical analgesic or anti-inflammatory products at the pain site within the past 72 hours Use of topical analgesic or anti-inflammatory products at the site of pain within the past 72 hours Presence of systemic diseases affecting pain Pregnancy or breastfeeding Concurrent use of medications affecting pain perception or mood Inability to comply with the study protocol or complete assessment forms Participation in another clinical trial within the past month M60 M15 M16 M17 M18 M19 M61 M62 M63 M05 M06 M07 M08 M10 M11 M12 M13 Myositis Polyosteoarthritis Osteoarthritis of hip Osteoarthritis of knee Osteoarthritis of first carpometacarpal joint Other and unspecified osteoarthritis Calcification and ossification of muscle Other disorders of muscle Disorders of muscle in diseases classified elsewhere Rheumatoid arthritis with rheumatoid factor Other rheumatoid arthritis Enteropathic arthropathies Juvenile arthritis Gout Other crystal arthropathies Other and unspecified arthropathy Other arthritis Treatment - Drugs Placebo Intervention group: recipients of a topical cream containing therapeutic oils extracted from Achillea millefolium (yarrow) and Tanacetum (tansy) plants.Usage: topical application on the painful area with gentle massage.Frequency: once to twice daily.Duration: at least 2 weeks and up to 4 weeks (depending on pain severity).Preparation: the cream is prepared by a licensed pharmacist in a pharmacy, free of unnecessary chemical additives, and is delivered to the patient at the clinic. Control group: recipients of a topical cream with the same appearance, color, smell, and texture as the herbal cream but without active therapeutic ingredients (i.e., free of Achillea millefolium and Tanacetum oils).Usage, dosage, and duration are the same as the intervention group.The purpose of this group is to control for the psychological (placebo) effect of the treatment. The primary outcome variables in this study include two measures: the intensity of pain in the affected area, assessed using the Visual Analog Scale (VAS) at the beginning and end of the intervention period, and patients’ motor function, evaluated through standardized questionnaires appropriate to the affected region. These two variables are analyzed to determine the efficacy of the herbal cream in reducing musculoskeletal pain and improving physical function in affected patients. Timepoint: Baseline: Before starting the use of the cream. Mid-study: Week 1 and Week 2 . End of intervention: After 2 to 4 weeks of use (depending on pain severity and prescribed duration). Method of measurement: Pain Intensity: Measured using the Visual Analog Scale (VAS). This scale consists of a 10-centimeter horizontal line on which the patient marks their perceived level of pain, ranging from “no pain” (score 0) to “worst imaginable pain” (score 10). Motor Function: Assessed using standardized and validated questionnaires specific to the pain location (e.g., the Oswestry Disability Index for lower back pain, WOMAC for knee pain, or the Neck Disability Index (NDI) for neck pain). Bahar Daru Mehr Company Approved 2025-06-25 Research Ethics Committee of Islamic Azad University-Shahrekord Branch Rahmatiyeh Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)