Skip to content

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221113056484N1
Enrollment
105
Registered
2022-12-10
Start date
2022-12-06
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Density of Postmenopausal Women. Age-related osteoporosis without current pathological fracture

Interventions

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 designe

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Masumeh Ghazanfarpour

Kerman University of Medical Sciences

m.ghazanfarpour@kmu.ac.ir+98 34 3132 5206

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026