Premenstural Syndrome. Unspecified behavioural syndromes associated with physiological disturbances and physical factors
Conditions
Interventions
Intervention 1: in imterventional groug:Sedamin Capsules, 530 mg, 2 times a day, orally for 3 months. Intervention 2: in control group:Placebo capsules, 2 times a day, orally for 3 months.
Placebo
Treatment - Drugs
in imterventional groug:Sedamin Capsules, 530 mg, 2 times a day, orally for 3 months
in control group:Placebo capsules, 2 times a day, orally for 3 months
Sponsors
Tehran University of Medical Science, vice chancellor for research(primary sponsor
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Single, 18-35 years, Having regular menstrual cycles and normal 21-35 and Duration of 7-3 days in the last 6 months, Lack of physical and emotional illness known And use of a Use of certain medications, no Occurrence of stressful events during the 3 months before study And diagnosis of premenstrual syndrome according to the Daily Form, Failure to participate in research studies of similar. Exclusion criteria of the study, Lack of volunteers willing to Continued drug use, Occurrence drug allergies, Stopping the medication for a week in the first cycle and irregular use of medication in cycles 2 and 3 for two days, Understanding of physical and mental illness during the study, Married during the study, Relatives death relatives and had surgery during the past two months. and third cycles are some criteria for stopping the study ; Understanding of physical and mental illness during the study; Married during the study; Relatives death and had surgery during the past two months .)
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in physical symptoms (headache, breast swelling and tenderness, back pain, abdominal pain, muscle pain, Overweight, swelling of extremities, nausea, bloat). Timepoint: One month, two months, three months after intervention. Method of measurement: Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in behavioral symptoms (fatigue lack of energy, insomnia, difficulty concentrating, increased appetite). Timepoint: One month, two months, three months after intervention. Method of measurement: Questionnaire.;Reduction in mood symptoms (anxiety and Worry, Restlessness, Nervous tension, Get angry, Snappish, irritableity, depression Withdrawal and irritability and sadness, crying for no reason, feeling alone, Freak out, Behavioral inconsistency). Timepoint: One month, two months, three months after intervention. Method of measurement: Questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Zahra Behboodi Moghadam
Tehran University of Medical Science
Outcome results
None listed