Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome

Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome

Phase 3 randomized triple-blind clinical trial of three witnessed blind groups, including an intervention group and a placebo group

The personal information form and PSST will be filled out by women referring to the traditional medicine clinic of Imam Reza Hospital in Mashhad for initial diagnosis. After reviewing the inclusion and non-inclusion criteria, eligible individuals will complete the DRSP for two months. After final confirmation, 80 samples will be randomly selected and complete a quality of life and temperament questionnaire. The permutation block method will be used to assign individuals to study groups. Sequence generation will be by random allocation software. The test group will receive Echium and fennel capsules and the control group will receive placebo. The study time is 2 cycles and during it the DRSP is completed.

Inclusion: Age 18 to 35 years Regular menstruation for 6 months Bleeding 3 to 9 and intervals 24 to 35 days Complete the conscious consent form minimum score of 19 from PSST non-Inclusion: History of mental illness, surgery, estrogen-related cancers, thyroid, liver, kidney disease, diabetes, hypertension Death of a loved one in the last six months use of anti-anxiety and anti-depressant, estrogen and progesterone drugs in the last three months Taking herbal, vitamin and mineral supplements over the past month allergy to Echium and fennel Pregnancy, lactation

Intervention: capsules (with a dose of 2 grams of Echium and 1 gram of fennel per day),in the second two weeks, In two cycles. placebo: starch capsule

The rate of changes in the severity of symptoms of PMS

The closure of the dormitories due to the prevalence of COVID-19 caused a change in the sampling location, followed by a change in the entry criteria (being single) and the non-entry criteria (pregnancy and lactation). Due to the termination of the previous statistics consultant's cooperation with the university and the change of the consultant, the change of randomization method and statistical software was done according to his opinion. For ease of swallowing by the patient, the volume of capsules was reduced and the dose was increased.

Permuted block randomization Unit: Individual It is not stratified Tools: random allocation statistical software Regarding concealment: A person outside the design will prepare sealed envelopes based on the random allocation sequence created and provide them to the executors.

The same capsules, with the same number, are placed in similar enveloped envelopes (from 1 to 80) based on a random assignment list by a person outside the research design.The study subjects receive the capsules monthly and in envelopes with the code. Participants, researchers, data evaluators, and data analysts are unaware of how the code is assigned.