Preparation of phytosome containing Foeniculum vulgare essential oil and its evaluation in reducing the pain intensity of primary dysmenorrhoea patients

Determining the effect of phytosome formulation containing fennel essential oil in reducing pain intensity in patients with primary dysmenorrhea

A clinical trial with a control group, with parallel groups, three blind strains, randomized by stratified random assignment method, phase 2 on 144 patients.

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Inclusion criteria: women with regular menstrual cycle suffering from primary dysmenorrhoea whose body mass index is also determined (less than or greater than 25). Exclusion criteria: use of birth control pills, painkillers, and other herbal medicines, as well as relaxation methods or acupressure to relieve primary dysmenorrhea; suffering from known kidney diseases; hepatic; respiratory and blood; Having an allergy to non-steroidal anti-inflammatory drugs and fennel, a history of severe or moderate anemia

4 groups receiving 4 doses of prepared phytosome (3 doses containing antole in low, medium, high doses and 1 dose without anethole (placebo)) 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.

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.

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.

Only part of the data, such as information about the main consequence or similar, can be shared

Start the access period 18 months after printing the results.

Data will only be available to researchers working at academic and scientific institutions

The data will only be used to inform the results of the study

Lorestan University of Medical Sciences

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