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IRCT20150830023823N6 IRCT 2026-01-13 Shiraz University of Medical Sciences The effect of topical Anethum graveolens Linn. seed (dill) oil on mild and moderate carpal tunnel syndrome Investigating the effect of topical Anethum graveolens Linn. seed (dill) oil on mild and moderate carpal tunnel syndrome a randomized, double-blind, placebo-controlled clinical trial 2026-03-06 anticipated 112 Complete https://irct.ir/trial/87694 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we use permutation block randomization method with blocks of size 4 and an allocation ratio of 1:1.Therefore, according to the sample size (112 subjects), 28 blocks of size 4 can be considered. For this purpose, since we have two interventions, we initially will name them A and B. Then by using Random Allocation Software 2.0, we generate a list of 112 random sequences. Finally, based on this random list, 56 patients will be allocated to group A and 56 patients to group B, Blinding description: The placebo will be made in color, odor, package and other characteristics similar to dill seed oil so that the patients and the researchers can`t distinguish between them. 3 Carpal tunnel syndrome. Intervention 1: Intervention group: Patients in intervention group use a wrist splint as standard treatment, every night and during sleep for 4 weeks. In addition, the topical dill seed oil as the test drug is applied twice a day (morning and evening) for 4 weeks to 5 drops per use on the palm and wrist area, 2-3 cm above and below wrist crease of the affected hand/hands, without massage. Also, patients receive two blister of 325 mg acetaminophen tablets as rescue analgesic to take PRN in case of pain due to CTS. Intervention 2: Control group: Patients in control group use a wrist splint as standard treatment, every night and during sleep for 4 weeks. In addition, the topical placebo oil is applied twice a day (morning and evening) for 4 weeks to 5 drops per use on the palm and wrist area, 2-3 cm above and below wrist crease of the affected hand/hands, without massage. Also, patients receive two blister of 325 mg acetaminophen tablets as rescue analgesic to take PRN in case of pain due to CTS. No - There is not a plan to make this available Justification or reason for not sharing IPD is for privacy
public Ali Tavakoli
Zand St، Medical School، Seventh floor، Persian Medicine Department
Shiraz Iran (Islamic Republic of) 7134845794 +98 712345145 tavakkolia@sums.ac.ir Shiraz University of Medical Sciences scientific Ali Tavakoli
Zand St، School of Medicine، Seventh floor، Persian Medicine Department
Shiraz Iran (Islamic Republic of) 7134845794 +98 712345145 tavakkolia@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 1-Clinical diagnosis of mild to moderate idiopathic carpal tunnel syndrome by an orthopedic specialist based on history and physical examination as at least 2 symptoms or 1 symptom plus 1 sign (symptoms include: pain, paresthesia, hypoesthesia, numbness and tingling, and signs include: positive Phalen test or Tinel test) 2-Electrodiagnostic evidence of mild to moderate idiopathic carpal tunnel syndrome which includes the following : • SDL > 3/7 m/s2c• SNCV < 40 m/sec• MDL > 4/2 m/sec• CL > 2/4 m/sec 3-Voluntary acceptance of the terms of participation in the study and sign the informed consent form 18 years 65 years Both Inability tto fill out the questionnaire. History of sensitivity to dill seed oil Severe idiopathic carpal tunnel syndrome based on electrodiagnostic tests History of severe trauma or fracture of the wrist bones or surgery or injection into the carpal tunnel during the past 6 months Thenar muscle atrophy Rheumatological diseases such as rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, and amyloidosis Pregnant or lactating women Diabetes or hypothyroidism Recent or ongoing inevitable use of corticosteroids or analgesics Coexisting serious illness, such as renal and heart failure life-threatening diseases such as advanced cancer Diseases that can mimic carpal tunnel syndrome, such as multiple sclerosis Use of anticancer drugs and corticosteroids Clinical and electrodiagnostic signs of polyneuropathy G56.0 Carpal tunnel syndrome Treatment - Drugs Treatment - Drugs Intervention group: Patients in intervention group use a wrist splint as standard treatment, every night and during sleep for 4 weeks. In addition, the topical dill seed oil as the test drug is applied twice a day (morning and evening) for 4 weeks to 5 drops per use on the palm and wrist area, 2-3 cm above and below wrist crease of the affected hand/hands, without massage. Also, patients receive two blister of 325 mg acetaminophen tablets as rescue analgesic to take PRN in case of pain due to CTS. Control group: Patients in control group use a wrist splint as standard treatment, every night and during sleep for 4 weeks. In addition, the topical placebo oil is applied twice a day (morning and evening) for 4 weeks to 5 drops per use on the palm and wrist area, 2-3 cm above and below wrist crease of the affected hand/hands, without massage. Also, patients receive two blister of 325 mg acetaminophen tablets as rescue analgesic to take PRN in case of pain due to CTS. Severity of disease (symptoms and functional status). Timepoint: At the beginning of the enrollment to the study and after 4 weeks of intervention. Method of measurement: Boston Questionnaire (BCTQ). Electrodiagnostic indices of the median nerve. Timepoint: At the beginning of the enrollment to the study and after 4 weeks of intervention. Method of measurement: Electromyography device. Local side effect. Timepoint: Daily. Method of measurement: Adverse Drug Reaction Reporting Form. Shiraz University of Medical Sciences Approved 2025-11-26 Ethics Committee of Shiraz Medical School Zand St. Shiraz Fars Iran (Islamic Republic of)