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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

Protocol summary

Study aim
To evaluate the effect of a topical herbal ointment on muscle performance, delayed onset muscle soreness, and mental well-being in professional football players after a single bout of football activity.
Design
Randomized, double blind, placebo controlled, parallel group clinical trial in professional male football players.
Settings and conduct
The study will be conducted in professional football players in the team training setting. After informed consent, participants will be screened and randomly assigned to intervention or control groups. Outcome assessors and participants will be blinded to group allocation.
Participants/Inclusion and exclusion criteria
Professional male football players in the predefined age range; regular football training experience; no injury or disease affecting test performance; no allergy to plants, essential oils, or ointment ingredients; no skin lesion at the application site; no use of anti inflammatory drugs, analgesics, or recovery methods outside the protocol; withdrawal in case of injury, skin reaction, protocol violation, absence, or personal request.
Intervention groups
The intervention group will receive a topical ointment containing mint, rosemary, thyme, and pennyroyal essential oils. The control group will receive a placebo ointment with similar appearance and application method. Both groups will be prohibited from using anti inflammatory drugs, analgesics, or recovery methods outside the protocol.
Main outcome variables
Countermovement jump performance; reactive strength index; delayed onset muscle soreness; mental well-being at 12, 36, and 60 hours after football activity.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260908070975N1
Registration date: 2026-09-12, 1405/06/21
Registration timing: prospective

Last update: 2026-09-12, 1405/06/21
Update count: 0
Registration date
2026-09-12, 1405/06/21
Registrant information
Name
Erfan Eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 992 429 7506
Email address
erfan.eslami@iau.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-23, 1405/08/01
Expected recruitment end date
2026-11-21, 1405/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of herbal ointment on delayed onset pain in athletes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
From 14 years old to 16 years old
Gender
Male
Phase
1
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Tehran Central Branch
Street address
NO 45,Erfaghi, sotani, tehranpars
City
Tehran
Province
Tehran
Postal code
1656836781
Approval date
2026-09-07, 1405/06/16
Ethics committee reference number
IR.IAU.CTB.REC.1405.061

Health conditions studied

1

Description of health condition studied
DOMS
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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

2

Description
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

3

Description
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

4

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Rehabilitation

2

Description
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
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
PAYAME MOKHABERAT
Full name of responsible person
Erfan Eslami
Street address
shariati, payam ertebatat
City
Tehran
Province
Tehran
Postal code
1656836781
Phone
+98 937 969 6714
Email
erfan.eslami10@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
MohamadAli AZARBAYJANI
Street address
SOHANAK
City
Tehran
Province
Tehran
Postal code
1111111111111
Phone
+98 912 317 2908
Email
ALI.AZARBAYJANI@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
MOHAMAD ALI AZARBAYJANI
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Physiology
Street address
IRAN
City
Tehran
Province
Tehran
Postal code
111111111
Phone
+98 912 317 2908
Email
ALI.AZARBAYJANI@GMAIL.COM

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
MOHAMD ALI AZARBAYJANI
Position
Professo
Latest degree
Subspecialist
Other areas of specialty/work
Physiology
Street address
IRAN
City
Tehran
Province
Tehran
Postal code
11111111
Phone
+98 912 317 2908
Email
ALI.AZARBAYJANI@GMAIL.COM

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
MOHAMAD ALI AZARBAYJANI
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Physiology
Street address
IRAN
City
Tehran
Province
Tehran
Postal code
111111111
Phone
+98 912 317 2908
Email
ALI.AZARBAYJANI@GMAIL.COM

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
Access will begin 6 months after publication of the final study results and will remain available for 5 years thereafter.
To whom data/document is available
Qualified academic researchers, faculty members, and other eligible investigators who submit a formal request.
Under which criteria data/document could be used
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.
From where data/document is obtainable
Requests should be submitted to the principal investigator via email or formal correspondence.
What processes are involved for a request to access data/document
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
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