The effect of chamomile extract stick on the severity of headache in patients with migraine headache.

Determining the effect of chamomile aqueous extract stick on headache severity in patients with migraine headaches

his study was a triple-blind randomized controlled clinical trial

At the beginning of the study, the MIDAS Questionnaire will be completed by the patients. Then, a chamomile essential oil stick will be provided to the intervention group, while a placebo stick will be provided to the control group. Participants will be instructed to apply the stick to the forehead and temporal areas for 30–40 minutes at the onset of headache and before taking any analgesic medication. Pain intensity during each attack will be recorded using the Numeric Rating Scale (NRS). After three months, the MIDAS questionnaire will be completed again.

efinitive diagnosis of migraine based on the International Headache Society (IHS) criteria Having at least 5 migraine headache attacks Duration of each attack between 4 and 72 hours Presence of at least two of the following characteristics: Unilateral pain Pulsating quality Moderate to severe intensity Aggravation by physical activity Presence of at least one of the following symptoms: Nausea or vomiting Photophobia Phonophobia Age between 18 and 65 years History of migraine for at least one year Willingness to participate in the study and completion of written informed consen

In this study, the intervention group consists of migraine patients who, during an attack, apply a chamomile extract stick topically. Headache severity and associated symptoms are assessed using standard questionnaires after application. The control group includes similar patients who use a placebo stick (without active chamomile extract), allowing a clear comparison between chamomile treatment and no active intervention.

Severity of migraine headache in patients

This study is a randomized, controlled, triple-blind clinical trial. Block randomization with a 1:1 allocation ratio was used to ensure balanced group sizes throughout the study. Variable block sizes were applied to reduce predictability of allocation sequences. The unit of randomization was individual; each eligible participant was independently assigned to either the intervention or control group. Stratified randomization was not applied in this study. Randomization Tools • Computer-generated random number software • Allocation sequence prepared by an independent investigator (supervisor) • Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) The allocation sequence was generated using computer-based random number software according to predetermined block sizes. The sequence was accessible only to the independent investigator responsible for allocation and was concealed from the clinical and research team. To prevent selection bias, allocation concealment was rigorously implemented: • Opaque, light-proof, sealed envelopes • Sequentially numbered according to the random allocation list • Each envelope contained either a chamomile-containing patch (intervention group) or an identical placebo patch (control group) • After enrollment, envelopes were opened sequentially without knowledge of content • Data were coded prior to statistical analysis to ensure that the statistician remained blinded Thus, triple blinding (participants, treating physician/research team, and statistician) was maintained throughout all stages of the study.

This study is a randomized controlled clinical trial with a triple-blind design. Blinding has been implemented as follows: Participants: After receiving a full explanation of the study objectives and procedures and providing written informed consent, participants are enrolled in the trial. They are unaware of the type of patch received (chamomile-containing patch or placebo). Both patches are identical in appearance, size, color, smell, texture, and packaging. Participants are fully aware of their participation in a clinical trial; blinding applies only to the type of intervention. Treating physicians and healthcare personnel: Physicians and any healthcare staff involved in patient care are blinded to group allocation. The intervention packages contain no identifying marks indicating group assignment. Outcome assessors and data collectors: The researcher responsible for follow-up assessments and data collection is blinded to group allocation. All data are recorded using participant codes without reference to intervention type. Statistician: Data are analyzed in a coded format (Group A and Group B). The statistician remains blinded to the actual group allocation until completion of the analysis. Random allocation is performed by an independent individual not involved in clinical assessment, data collection, or statistical analysis, using computer-generated random numbers. Allocation concealment is ensured through sequentially numbered, opaque, sealed envelopes. Neither the principal investigator nor the research team has access to the allocation sequence. Therefore, participants, care providers, outcome assessors, and the statistician are all blinded to the intervention assignment, and allocation concealment is fully maintained throughout the study

In this study, individual participant data will be shared only after de-identification to ensure privacy. The shared dataset will include primary outcome measures such as headache severity, duration of attacks, frequency of episodes, and associated symptoms, along with standardized questionnaires (e.g., MIDAS and VAS). No personal or identifiable information will be released. Access to these data will be provided after publication of the main study results, through the corresponding author or the institutional repository of Shahid Sadoughi University of Medical Sciences, Yazd, Iran

The de-identified study documents and datasets will be made available after completion of the trial and publication of the main results. Start of access period: 6 months after publication of the study results in peer-reviewed journals Duration of availability: Data will remain accessible for at least 5 years following publication.

The de-identified data and study documents will be available only to researchers affiliated with recognized academic institutions and scientific centers. Requests must be submitted through the corresponding author or the institutional repository. Access for non-academic or industry professionals will be considered only if a formal research collaboration with the university or study team is established.

Data may be used only for scientific and academic research purposes; commercial or promotional use is prohibited. Analyses must be limited to research questions related to migraine and complementary therapies. Use of data must comply with research ethics principles and regulations of Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Applicants must submit their approved research proposal or study plan along with the request. Any publication resulting from these data must include proper citation of the original study. Data will be shared only in de-identified format, excluding any personal or identifiable information. Access is subject to approval by the university’s ethics committee and the corresponding author.

Dr. Hossein Nazmieh (Assistant Professor) Address: Faculty of Nursing, Shahid Sadoughi University of Medical Sciences, Ibn Sina Avenue, Yazd, Iran 989135380679 Hossin.nazmiah@gmail.com

Submission of formal request: Applicants must submit a formal request including the purpose of research and an approved proposal to the corresponding author or supervisor. Initial review of request: The research team and university ethics committee will review the request within 2 weeks. Ethics committee approval: If required, the request will be referred to the university’s ethics committee. This step usually takes 2–4 weeks. Signing of data use agreement: Once approved, applicants must sign a data use agreement outlining conditions (e.g., non-commercial use, confidentiality). Delivery of data/documents: De-identified datasets or requested documents will be provided within 2 weeks after the agreement is signed. Estimated total duration: Typically 6–10 weeks from submission of request to receipt of data.