igella sativa effects on the menopausal complications

Phase 3

• Conditions: menopausal complications.; Menopausal and other perimenopausal disorders

• Registration Number: IRCT2015062122854N1
• Lead Sponsor: Vice chancellor for research, Tehran University of Medical Sciences

Brief Summary

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 />

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 70

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.