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IRCT20250203064631N1 IRCT 2025-06-02 Mashhad University of Medical Sciences Investigating the Effects of Zingiber officinale plate on Growth Pains in Pediatrics Investigating the Effects of Zingiber officinale plate on Growth Pains in Pediatrics 2025-06-05 anticipated 50 Complete https://irct.ir/trial/83513 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block method will be used to generate the sequence of random allocation of individuals to the study groups. The sequence of random allocation of individuals will be done using Random Allocation Software and a block size of 4. In this study, 6 blocks of 4 will be our guide in this study. The block randomization method from the specified blocks should be selected each time random numbers are generated, Blinding description: To conceal the allocation, before assigning the individual, using sealed opaque envelopes, the random sequences created are recorded on a card and the cards are placed inside the envelopes in order. In order to maintain the random sequence, the envelopes are numbered in the same order on the outside. Finally, the envelopes are taped shut and placed in a box in order. At the start of the participants' arrival, based on the order of the eligible participants entering the study, and after ensuring that the individual has entered the study, one of the envelopes is opened in order and the assigned group of that participant is revealed. 3 Growing pains. Intervention 1: Intervention group: Patients in the intervention group will receive tablets containing ginger extract (hydroalcoholic extract equivalent to 250 mg of ginger rhizome powder, standardized based on Shogaol and phenolic acids content) BID for 3 months. Intervention 2: Control group: Patients in this group will receive placebo tablets (BID), which are similar in appearance to ginger tablets, for 12 weeks. Yes - There is a plan to make this available What will be shared: After the results are published in reputable journals, interested parties can access the article. When: The period of access to results begins after the completion of the research. To whom: All people interested in the research topic can access the results. Conditions: After publishing the results in the form of a thesis and article, interested parties who need further explanations can access the authors through the communication channels included in the article and ask their questions. If raw data is needed, approval or disagreement will be announced after the research team reviews it. Where to obtain: To receive the documentation, you can refer to the email address of the responsible author. How to obtain: Requests will be responded to within a maximum of one week. Comments:
public Abdolreza Malek
Block 2,Third Floor, Building 46, Corner of Ibn Sina 2/3, Opposite Three Roads of Literature, Ibn Sina Street, Mashhad, Khorasan Razavi, Iran
Mashhad Iran (Islamic Republic of) ٩٩١٩١ ٩١٧٧٨ +98 915 313 1417 malekar@mums.ac.ir Mashhad University of Medical Sciences scientific Abdolreza Malek
Block 2,Third Floor, Building 46, Corner of Ibn Sina 2/3, Opposite Three Roads of Literature, Ibn Sina Street, Mashhad, Khorasan Razavi, Iran
Mashhad Iran (Islamic Republic of) ٩٩١٩١ ٩١٧٧٨ +98 915 313 1417 malekar@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age 3 to 12 years Clinical diagnosis of growing pains by a specialist physician after ruling out organic causes of pain. Patient and guardian consent to the study and completion of the informed consent form by the patient's legal guardian. 3 years 12 years Both Having underlying diseases that may cause similar pain. Regular use of anti-inflammatory or analgesic medications. Known allergy to ginger. R29.8 Other and unspecified symptoms and signs involving the nervous and musculoskeletal systems Treatment - Drugs Placebo Intervention group: Patients in the intervention group will receive tablets containing ginger extract (hydroalcoholic extract equivalent to 250 mg of ginger rhizome powder, standardized based on Shogaol and phenolic acids content) BID for 3 months. Control group: Patients in this group will receive placebo tablets (BID), which are similar in appearance to ginger tablets, for 12 weeks. Symptoms associated with pain. Timepoint: At the beginning of the study and after three months of receiving the drug. Method of measurement: The Visual Analogue Scale (VAS) of pain and the Tool for Children’s Growing Pains complement the checklist of symptoms associated with pain, including duration of pain, sequence of pains, sequence of awakenings from sleep or sleep disturbance due to growing pains. Duration of pain. Timepoint: At the beginning of the study and after three months of receiving the drug. Method of measurement: The Visual Analogue Scale (VAS) of pain and the Tool for Children’s Growing Pains complement the checklist of symptoms associated with pain, including duration of pain, sequence of pains, sequence of awakenings from sleep or sleep disturbance due to growing pains. Sequence of pains. Timepoint: At the beginning of the study and after three months of receiving the drug. Method of measurement: The Visual Analogue Scale (VAS) of pain and the Tool for Children’s Growing Pains complement the checklist of symptoms associated with pain, including duration of pain, sequence of pains, sequence of awakenings from sleep or sleep disturbance due to growing pains. Wake-up sequence. Timepoint: At the beginning of the study and after three months of receiving the drug. Method of measurement: The Visual Analogue Scale (VAS) of pain and the Tool for Children’s Growing Pains complement the checklist of symptoms associated with pain, including duration of pain, sequence of pains, sequence of awakenings from sleep or sleep disturbance due to growing pains. Possibility of falling asleep due to growing pains. Timepoint: At the beginning of the study and after three months of receiving the drug. Method of measurement: The Visual Analogue Scale (VAS) of pain and the Tool for Children’s Growing Pains complement the checklist of symptoms associated with pain, including duration of pain, sequence of pains, sequence of awakenings from sleep or sleep disturbance due to growing pains. Mashhad University of Medical Sciences Approved 2025-04-08 Ethics Committee of the Faculty of Medicine, Mashhad University of Medical Sciences Central Organization of Mashhad University of Medical Sciences, Knowledge and Health City,between Shahid Al Shahidi Square and Shahid Javan Square,end of Shahid Fakuri Boulevard,Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)