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IRCT2015062122854N1 IRCT 2016-02-06 Vice chancellor for research, Tehran University of Medical Sciences Nigella sativa effects on the menopausal complications Clinical trial comparing the effects of Nigella sativa and placebo on metabolic markers in postmenopausal women 2015-10-23 anticipated 70 Complete https://irct.ir/trial/19616 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: At the first session after history taking and based on routine tests were taken in the menopausal period, people who have the inclusion criteria enter the study. After a thorough examination, weight and waist circumference are measured and written informed consent is taken. Then their blood tests including CBC, fasting blood glucose, total cholesterol, high density cholesterol, triglycerides and CRP are checked. The kit used to measure blood sugar, triglycerides and total cholesterol belongs to Parsazmoon and measurement kit of the high density cholesterol and C-reactive protein related to Unique Company. Low density cholesterol determined through the Friedewald formula. The type of system used is RAXT type 1,000. History taking, examination, measurement of weight (using the digital scale model QC, type 6173 BV 01015, making China the power measurement Max 150 kg weight) and consent will done by a general practitioner. Blood tests perform in the laboratory of Moheb Yas Comprehensive Women’s Hospital. Then people using two alleles randomization blocks of (the AABB, ABAB, ABBA, BAAB, BBAA, BABA… /control group: A, study group: B), divided into two groups. Pharmaceutical compounds packed into similar bags, so the patient or drug distributor is not aware of its contents until the opening of envelopes. At last, obtained experimental and clinical data analyze with SPSS software. 3 menopausal complications. 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 Tehran University. Intervention 2: 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 brand is Shoniz. Case group received medication as daily oral capsules, along with diet and exercise for 2 months. Objectives: This study was conducted in menopausal women to determine the metabolic effect of Nigella sativa.<br /> <br /> Methods: A randomized, double-blinded placebo-controlled, 2 months, parallel-group clinical trial was conducted. One hundred forty menopausal women within the age limit of 45-60 years old, who suffering from metabolic disorder were assigned into NS (n = 70) and placebo (n = 70) groups to receive capsule of 500 mg/d NS, or starch in one dose, respectively. Anthropometric and biochemical parameters were measured at baseline and 2nd month after administration to determine their waist, body weight, serum lipid profile, fasting blood sugar and HbA1C.<br /> Results: Some markers such as low density lipoprotein (LDL) -total Cholesterol-triglyceride (TG) - fasting blood sugar (FBS) significantly decreased in the Nigella sativa group. In addition, the reduction and change of some markers such as low density lipoprotein (LDL) – total Cholesterol – triglyceride (TG) - fasting blood sugar (FBS) - HbA1C as well as HDL increase, following treatment was significant (P-value < 0.05).<br /> Conclusion: these results suggested that treatment with N. sativa exert a therapeutic effects by improving lipid profile, blood sugar and HbA1C.<br /> <br /> Key words: menopause, metabolic syndrome, Nigella sativa<br />
public Masud Yunesian
Department of Environmental Health Engineering, School of Public Health, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) +98 21 8163 3628 yunesian@tums.ac.ir Tehran University of Medical Sciences scientific Mahboobe shirazi
Tehran General Women Hospital
Tehran Iran (Islamic Republic of) +98 21 8889 7761 mahboobeh.shirazi@yahoo.in fatemeh.khodakarami@gmail.com Tehran University of medical sciences Iran (Islamic Republic of) 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. 45 years 60 years Female N95 Menopausal and other perimenopausal disorders 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 brand is Shoniz. Case group received medication as daily oral capsules, along with diet and exercise for 2 months. 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. 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 intervention and 2 months after intervention. Method of measurement: Questionnaire. Surgical history. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire. C reactive protein. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Blood test (unique kit), milligram/liter. Blood cell count. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Blood test, number per microliter. Vice chancellor for research, Tehran University of Medical Sciences Approved 2015-04-14 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Pursyna St., 16th Azar St., Keshavarz Blvd. Tehran Iran (Islamic Republic of)