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IRCT20221113056484N1 IRCT 2022-12-10 Kerman University of Medical Sciences 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 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 2022-12-06 anticipated 105 Complete https://irct.ir/trial/66820 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible Patients will be selected by Convenience Sampling Method. Block Randomization Method (Bone Density Status: Normal, Osteopenia and Osteoporosis) will be used to allocate the samples to 5 groups. According to the number of groups and the size of total sample, 7 blocks of 15 numbers will be selected. The Randomization List will be created using R Statistical Software and the block.random() Command. 0 (exploratory trials) Bone Density of Postmenopausal Women. Intervention 1: The first intervention group: The Education will consist of 4 sessions of 1.5 hours once a week based on Information Motivation Behavior Model. The content of these sessions is designed to increase Information, Motivation, Self-Efficacy and Decisive Behavior in the field of Bone Density of Postmenopausal Women. Intervention 2: The second intervention group: Will have an oral Capsule containing 500 mg Black Seed and Palm Date Spathe daily for 6 months which was designed at the Faculty of Pharmacy, Kerman University of Medical Sciences. Intervention 3: The third intervention group: The Common treatment is 1500 mg Calcium Tablet daily and 50000 IU Vitamin D3 Tablet every two weeks for 6 months. Intervention 4: The fourth intervention group: The Common treatment and Capsule containing Black Seed and Palm Date Spathe will be used at the same time for 6 months. Intervention 5: Control group: Will not receive any type of treatment. Yes - There is a plan to make this available What will be shared: Information on the main outcome When: 6 months after publication of the article To whom: Researchers working in academic and scientific institutions Conditions: To develop Bone Density management programs and only with Academic Affiliation Where to obtain: Dr. Masumeh Ghazanfarpour m.ghazanfarpour@kmu.ac.ir How to obtain: Sending an email to Dr. Masoumeh Ghazanfarpour and after going through the process of verifying the applicant's identity for two weeks, an answer will be given. Comments:
public Dr. Masumeh Ghazanfarpour
Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Haft Bagh Alavi Highway
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5206 m.ghazanfarpour@kmu.ac.ir Kerman University of Medical Sciences scientific Dr. Masumeh Ghazanfarpour
Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Haft Bagh Alavi Highway
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5206 m.ghazanfarpour@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) 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 45 years 65 years Female 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 M81.0 Age-related osteoporosis without current pathological fracture Treatment - Other Treatment - Drugs Treatment - Drugs Treatment - Drugs N/A The first intervention group: The Education will consist of 4 sessions of 1.5 hours once a week based on Information Motivation Behavior Model. The content of these sessions is designed to increase Information, Motivation, Self-Efficacy and Decisive Behavior in the field of Bone Density of Postmenopausal Women. The second intervention group: Will have an oral Capsule containing 500 mg Black Seed and Palm Date Spathe daily for 6 months which was designed at the Faculty of Pharmacy, Kerman University of Medical Sciences. The third intervention group: The Common treatment is 1500 mg Calcium Tablet daily and 50000 IU Vitamin D3 Tablet every two weeks for 6 months. The fourth intervention group: The Common treatment and Capsule containing Black Seed and Palm Date Spathe will be used at the same time for 6 months. Control group: Will not receive any type of treatment. 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. Kerman University of Medical Sciences Approved 2022-11-19 Ethics Committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Haft Bagh Alavi Highway Kerman Kerman Iran (Islamic Republic of)