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IRCT20100420003760N6 IRCT 2023-03-29 Khoram-Abad University of Medical Sciences Investigating the analgesic effect of Foeniculum vulgare essential oil phytosome AFP Preparation of phytosome containing Foeniculum vulgare essential oil and its evaluation in reducing the pain intensity of primary dysmenorrhoea patients 2023-06-22 anticipated 36 Complete https://irct.ir/trial/69194 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of patients into four groups and also using stratified random allocation. In this way, classes are made based on age group (below 30 years and greater than or equal to 30 years), primary dysmenorrhea severity (moderate or severe), body mass index status (less than 25 and greater than or equal to 25) are constructed (12 classes in total).. Within each class, random permutation blocks are used to assign samples to the required groups. To create random sequences, letters A, B , C or D(corresponding to the experimental group) will be used as follows. ABCD: 0-3 ABDC: 4-7 ACBD: 8-11 ACDB:12-15 . . DABC DBAC DCAB DCBA: 92-95 Then a corner of the table of random numbers is selected and two-digit numbers are read from top to bottom, and finally, according to the read number, a random sequence of letters A to D is registered in the desired floor. Finally, a random sequence of letters A to D (corresponding to the 4 experimental groups) will be created in each class of all existing classes, and the samples will be assigned to 4 groups based on this random sequence, Blinding description: This study will be triple blind, which means that the pain intensity assessor, the patient and the data analyst are not aware of the type of treatment assigned to the patient. In addition, the decipherer is not a member of the research team and the edible capsules in all groups are completely identical in appearance. Data registration in the statistical software and data analysis is done by the statistical consultant without mentioning the names of the groups. 2 Primary dysmenorrhea. Intervention 1: Intervention group: group receiving a low dose of phytosome made containing anethole and mefenamic acid. Intervention 2: Intervention group: the group receiving a moderate dose of phytosome made containing anethole and mefenamic acid. Intervention 3: Intervention group: the group receiving a high dose of phytosome made containing anethole and mefenamic acid. Intervention 4: Control group: group receiving 0 dose of phytosome made containing anethole and mefenamic acid. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main consequence or similar, can be shared When: Start the access period 18 months after printing the results. To whom: Data will only be available to researchers working at academic and scientific institutions Conditions: The data will only be used to inform the results of the study Where to obtain: Lorestan University of Medical Sciences How to obtain: Refer to Lorestan University of Medical Sciences, Vice Chancellor of Research and Technology, Research Projects Department, Management of Research Projects Department, 066333120175, Mrs. Sajedi , fax:066333120173 call mrs. zarei 0989167083314 Comments:
public Marzieh Rashidipour
No. 140, Razi Ave. Pajohandeh Blvd, Herbal Research Center
Khorramabad Iran (Islamic Republic of) 6814989468 +98 66 3312 0172 m_rashidi80@yahoo.com Khoram-Abad University of Medical Sciences scientific Marzieh Rashidipour
No. 140, Razi Ave. Pajohandeh Blvd, Herbal Research Center
Khorramabad Iran (Islamic Republic of) 6814989468 +98 66 3312 0172 m_rashidi80@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Women with regular menstrual cycles with primary dysmenorrhea whose body mass index is also determined (less than or greater than 25). 18 years 45 years Female Use of birth control pills Use of pain relievers Using pain relief methods such as acupressure Suffering from certain diseases Having an allergy to non-steroidal anti-inflammatory drugs and fennel N94.4 Primary dysmenorrhea Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: group receiving a low dose of phytosome made containing anethole and mefenamic acid Intervention group: the group receiving a moderate dose of phytosome made containing anethole and mefenamic acid Intervention group: the group receiving a high dose of phytosome made containing anethole and mefenamic acid Control group: group receiving 0 dose of phytosome made containing anethole and mefenamic acid Pain level is measured by two methods of interview and VAS questionnaire (0-10) at the beginning and end of each cycle during 3 consecutive cycles. Timepoint: Pain intensity between three consecutive cycles (12 weeks) in different experimental groups. Method of measurement: Pain level is measured by two methods of interview and VAS questionnaire (0-10). Pain level is measured by two methods of interview and VAS questionnaire (0-10) at the beginning and end of each cycle during 3 consecutive cycles. Timepoint: Pain level is measured by two methods of interview and VAS questionnaire (0-10) at the beginning and end of each cycle during 3 consecutive cycles. Method of measurement: Pain intensity between three consecutive cycles (12 weeks) in different experimental groups. Khoram-Abad University of Medical Sciences Approved 2023-03-15 Ethic Committee of Lorestan University of Medical Sciences No 20, Anooshirvan Rezaei Square, Lorestan University of Medical Sciences Khorramabad Lorestan Iran (Islamic Republic of)