Effect of Capsule containing Black Seed (Nigella Sativa L.) and Palm Date Spathe in comparison with Education based on Information-Motivation-Behavior (IMB) Model on Bone Density of Postmenopausal Wome

Early Phase 1

Recruiting

• Conditions: Bone Density of Postmenopausal Women.; Age-related osteoporosis without current pathological fracture; M81.0

• Registration Number: IRCT20221113056484N1
• Lead Sponsor: Kerman University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

Age 45-65 years
Normal Menopause, When the person is Amenorrhoeic for at least one year and is not the result of Surgery, Chemotherapy or Premature Menopause
Informed Consent to participate in the Study

Exclusion Criteria

Diseases affecting Bone Metabolism (Endocrine: Hypopituitarism, Growth Hormone Deficiency, Hyperprolactinemia, Hypercortisolism (Cushing's Disease and Syndrome), Thyroid Disorders (Hypothyroidism and Hyperthyroidism), Hyperparathyroidism, Diabetes Mellitus type 1 and 2, Untreated Hypogonadism, Primary Hyperaldosteronism. Gastrointestinal: Anorexia Nervosa, Bulimia Nervosa, Bariatric Surgery, Malabsorption, Crohn's Disease, Ulcerative Colitis, Celiac Disease, Chronic Diarrhea, Stomach and Duodenal Ulcers under treatment or a history of their association with Gastrointestinal Bleeding. Autoimmune: Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus. Connective Tissue Disorders: Ehlers-Danlos Syndrome, Marfan Syndrome. Hematology: Beta Thalassemia Major. Other: Acute or Chronic disease (Liver, Kidney or Heart Disease), Types of Cancer, Hypo/Hypercalcemia. Severe Psychiatric Disorders including Chronic Anxiety and Depression Disorders (For more than 2 years)
Underlying causes of Prolonged Immobility (Such as Spinal Cord Injury, Parkinson's Disease, Stroke, Muscular Dystrophy, Ankylosing Spondylitis)
History of Bone Fracture in the last 3 years
Taking any of the Osteoporosis Treatment Drugs (Antiresorptive/Anabolic)
Use of Tibolone or any type of Hormone Therapy (Systemic or Local) three months before the intervention
Use of Anticonvulsants, Glucocorticoids (more than 5 mg Prednisolone per day or use for three months or more), Chemotherapy Drugs, Antiretrovirals, Proton Pump Inhibitors, Cyclic Diuretics, Thiazolidinediones, Selective Serotonin Reuptake Inhibitors (SSRIs) for at least 6 months, Benzodiazepines, Barbiturates, Beta-Blockers for more than 5 years, Statins, Unfractionated Heparin/Low Molecular Weight Heparin/Warfarin and Calcineurin Inhibitors
Treatment with other Phytoestrogens three months before the intervention
History of Allergy to Black Seed or Palm Date Spathe
History of Smoking more than 20 Cigarettes per day
Consumption of Alcoholic Beverages 3 units or more per day (Each unit is equivalent to 10 ml or 8 grams)
The 10-year Fracture Risk is higher than the permissible threshold for delaying routine treatments

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The result of Dual-Energy X-ray Absorptiometry (T-Score, Z-Score and Bone Mineral Density). Timepoint: Before starting the study and 6 months later. Method of measurement: Dual-Energy X-ray Absorptiometry Scanner.;Serum Calcium level. Timepoint: Before starting the study and 6 months later. Method of measurement: Laboratory kit.;Serum Phosphorus level. Timepoint: Before starting the study and 6 months later. Method of measurement: Laboratory kit.;Serum Alkaline Phosphatase level. Timepoint: Before starting the study and 6 months later. Method of measurement: Laboratory kit.