IRCT20221113056484N1招募中早期 1 期
Investigation of the 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 Women
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 45 years 至 65 years（—）
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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