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
Determining the effect of topical Anethum graveolens Linn. seed (dill) oil on mild and moderate carpal tunnel syndrome
Design
A randomized, double-blind, parallel-design controlled clinical trial on 112 patients. Random allocation software 2.0 uses for randomization.
Settings and conduct
The study site is the clinics affiliated with Jahrom University of Medical Sciences.The study is double blind. patients and researchers are blinded.. Patients are followed up throughout the study and are visited at the beginning of the study and after 4 weeks of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients (18-65 years) with diagnosis of mild to moderate idiopathic carpal tunnel syndrome based on history, physical examination, and electrodiagnostic evidence.
Exclusion criteria: Patients with severe idiopathic carpal tunnel syndrome- Pregnant or lactating women - HX 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- HX of rheumatological diseases- Diabetes or hypothyroidism- Recent or ongoing inevitable use of corticosteroids or analgesics
Intervention groups
112 eligible patients will be randomly assigned into two groups: the intervention group will receive dill seed oil and the control group placebo oil. The topical oil (drug or placebo) is applied twice a day (morning and evening) for 4 weeks to 5 drops per use on the palm and wrist area without massage. Also, patients in both groups use a wrist splint as standard treatment, every night and during sleep for 4 weeks. Moreover, patients in both groups are given two blister of 325 mg acetaminophen tablets as rescue analgesic to take PRN in case of pain due to CTS.
Main outcome variables
Severity of disease (symptoms and functional status) and electrodiagnostic parameters of the median nerve
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150830023823N6
Registration date:2026-01-13, 1404/10/23
Registration timing:prospective
Last update:2026-01-13, 1404/10/23
Update count:0
Registration date
2026-01-13, 1404/10/23
Registrant information
Name
Ali Tavakoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 1028
Email address
tavakkolia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-06, 1404/12/15
Expected recruitment end date
2026-11-06, 1405/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of topical Anethum graveolens Linn. seed (dill) oil on mild and moderate carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2025-11-26, 1404/09/05
Ethics committee reference number
IR.SUMS.MED.REC.1404.471
Health conditions studied
1
Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
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)
2
Description
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
Secondary outcomes
1
Description
Local side effect
Timepoint
Daily
Method of measurement
Adverse Drug Reaction Reporting Form
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics affiliated with Jahrom University of Medical Sciences
Full name of responsible person
Mohammad Nikbakhsh
Street address
Ostad Motahari St., Alley 25
City
Jahrom
Province
Fars
Postal code
7415713597
Phone
+98 71 5434 2006
Email
honariclinic@jums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Tavakoli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand St، Medical School، Seventh floor، Persian Medicine Department
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 712345145
Email
tavakkolia@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Tavakoli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand St، School of Medicine، Seventh floor، Persian Medicine Department
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 712345145
Email
tavakkolia@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Tavakoli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand St، School of Medicine، Seventh floor، Persian Medicine Department
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 712345145
Email
tavakkolia@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD