menopausal complications. Menopausal and other perimenopausal disorders
Conditions
Interventions
Intervention 1: Intervention group 1: This group received oral placebo capsules daily, along with diet and exercise for 2 months. Placebo is made from starch and prepared by the Faculty of Pharmacy Te
Placebo
Treatment - Drugs
Intervention group 1: This group received oral placebo capsules daily, along with diet and exercise for 2 months. Placebo is made from starch and prepared by the Faculty of Pharmacy Tehran University.
Intervention group 2: Nigella sativa extract in order to better reception, placed in vinegar for a week and then come in shape of 500 mg capsules. Tuba Salamatkadeh produced these capsules and its bra
Sponsors
Vice chancellor for research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
45 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Abdominal obesity: waist circumference greater than 88 cm 2. Triglyceride level of more than 150 and less than 199 milligrams per deciliter 3. High density cholesterol level less than 50 milligrams per deciliter 4. Systolic blood pressure: 139- 130 mm Hg and diastolic blood pressure: 85-89 mm Hg 5. Fasting blood glucose level of 100 to 125 milligrams per deciliter (If patients had 3 criteria or more than 3 criteria known as cases of metabolic syndrome) 6. Total cholesterol level greater than 200 and less than 239 milligrams per deciliter 7. Low density cholesterol level greater than 100 and less than 150 milligrams per deciliter 8. People who are interested in participating in the study and signed an informed consent. Exclusion criteria: 1. Pregnancy 2. Diabetes type one or two (fasting blood sugar more than 126) 3. Gouty arthritis 4. Blood pressure more than Stage 1 (systolic blood pressure over 139 mm Hg and diastolic blood pressure over 89 mm Hg) 5. Acute or chronic coronary artery disease or a history of cardiovascular events 6. Liver disorders (elevated liver enzymes more than three times normal) 7. Chronic kidney disease (creatinine level more than one and a half milligrams per deciliter) 8. A strong family history of dyslipidemia 9. Those do exercise in level of moderate or vigorous 10. Taking drugs such as supplements or drugs used in traditional medicine, the consumption of alcohol within the past month 11. Patients undergoing basic treatment of hyperlipidemia (cholesterol over 240, triglycerides 200 and Low density cholesterol levels over 150) 12. People who did not sign the consent form, tend not to follow the steps, moved to another location or have died during the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood sugar. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Parsazmoon lab kit, milligram per deciliter.;Total cholesterol level. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Parsazmoon lab kit, milligram per deciliter.;High density cholesterol level. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Unique lab kit, milligram per deciliter.;Low density cholesterol level. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Friedewald formula.;Triglycerid level. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Parsazmoon lab kit, milligram per deciliter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Nausea. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire.;Vomiting. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire.;Headache. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire.;Constipation. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire.;Drowsiness. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire.;Vaginal dryness. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire.;Sexual dysfunction. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire.;Vaginal atrophy. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Examination.;Vaginal itching. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire.;Breast pain. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire.;Skin changes. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire.;Age. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire.;Parity. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire.;Weight. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Examination.;Waist circumference. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Examination, centimeter.;Flushing. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire.;Job. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire.;Medicine consumption. Timepoint: Before interventio | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMasud Yunesian
Tehran University of Medical Sciences
Outcome results
None listed