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IRCT20131009014957N4 IRCT 2018-07-16 Tabriz University of Medical Sciences The effect of Curcumin, Nigella Sativa, and Curcumin-Nigella Sativa on outcomes related to primary osteoporosis among postmenopausal women The effect of Curcumin, Nigella Sativa, and Curcumin-Nigella Sativa on cellular- molecular and clinical outcomes related to primary osteoporosis among postmenopausal women: A triple blind randomized controlled trial 2018-08-16 anticipated 120 Complete https://irct.ir/trial/32065 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Women with primary osteoporosis were randomly assigned into four groups recieving: 1) Nigella Sativa capsule and curcumin placebo; 2) curcumin capsule and Nigella Sativa placebo; 3) Nigella Sativa and curcumin capsule ; or 4) placebo capsules of Nigella Sativa and curcumin. Allocation sequence will be determined using random blocking of blocks 4 and 8 in RAS software (Random Allocation Software) using a 1: 1: 1: 1 assignment ratio. To conceal the allocation, the medications will be placed inside a consecutively numbered sealed opaque envelopes. Preparation of envelopes and sequence generation will be done by a person not involved in participant recruitment or data collection, Blinding description: The medications and their placebo will be prepared by the pharmaceutical company in identical shape, color and smell. Investigators, health care providers, outcome assessors, and statistical analyst will be blinded. 3 Postmenopausal osteoporosis. Intervention 1: Intervention group 1: One Nigella Sativa oil soft-gel capsule 1000 mg once a day prepared by Baryj Essence pharmaceutical company and one Curcumin placebo capsule containing 80 mg carboxymethyl cellulose once a day produced by Exir Nano Sina company, orally by for 6 months,. Intervention 2: Intervention group 2: One Curcumin soft-gel capsule containing 80 mg Curcumin as nanomicelle once a day prepared by Exir Nano Sina company, and one Nigella Sativa placebo capsule containing 1000 mg carboxymethyl cellulose once a day produced by Baryj Essence pharmaceutical company, orally for 6 months. Intervention 3: Intervention group 3: One Nigella Sativa oil soft-gel capsule 1000 mg once a day prepared by Baryj Essence pharmaceutical company and one Curcumin soft-gel capsule containing 80 mg Curcumin as nanomicelle once a day prepared by Exir Nano Sina company, orally for 6 months. Intervention 4: Control group: One Nigella Sativa placebo soft-gel capsule containing 1000 mg carboxymethyl cellulose once a day prepared by Baryj Essence pharmaceutical companyand one Curcumin placebo capsule containing 80 mg carboxymethyl cellulose once a day prepared by Exir Nano Sina company, orally for 6 months. Yes - There is a plan to make this available What will be shared: Requested data will be provided to researchers for statistical analysis of the submitted proposal (meta-analysis). When: starting immediately after publication To whom: Data will be available to researchers as well as to journals. Conditions: The data will be available to researchers upon request and submission of a proposal to perform meta-analysis using IPD data after being unidentified. Also, in exceptional cases, data will be made available to journals for checking. Where to obtain: Refer to the email address (farshbafa@tbzmed.ac.ir). How to obtain: The requests will be sent by email and data will be available within a week. Comments:
public Dr. Azizeh Farshbaf-Khalili
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 1928 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Azizeh Farshbaf-Khalili
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 1928 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Postmenopausal women aged 50 to 65 years Ability to self-care Resident of Tabriz city Menstrual cessation for at least 12 consecutive months Low bone density (T-score <-2.5) in lumbar spine or hip (total and femoral neck) No fracture history The ability to communicate verbally for answering questions 50 years 65 years Female T-score≤-4 in lumbar spine or T-score≤-3.5 in femoral neck bone Renal failure and diseases Bone disease other than osteoporosis The use of medications that affect bone metabolism, including intravenous bisphosphonate over the past 5 years, oral bisphosphonate use in the last 6 months, cumulative oral bisphosphonate use for more than 3 years, or more than 1 month between 6-12 months before the study, Use of parathyroid hormone analogues over the past 12 months or strontium, fluoride or cathepsin k inhibitor at any time, use of hormonal medications or corticosteroids during the study or within 3 months before (or more). Chronic liver disease Other systemic diseases, such as diabetes, gastrointestinal disorders, and endocrine disorders Mental illness, as reported by the woman The malignancy, as reported by the woman Taking anti-coagulants, and coagulation disorders Stomach ulcers and gallstones The levels of 25-hydroxyvitamin D less than 20ng/ ml Current Hypercalcemia or hypocalcemia M81 Osteoporosis without current pathological fracture Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: One Nigella Sativa oil soft-gel capsule 1000 mg once a day prepared by Baryj Essence pharmaceutical company and one Curcumin placebo capsule containing 80 mg carboxymethyl cellulose once a day produced by Exir Nano Sina company, orally by for 6 months, Intervention group 2: One Curcumin soft-gel capsule containing 80 mg Curcumin as nanomicelle once a day prepared by Exir Nano Sina company, and one Nigella Sativa placebo capsule containing 1000 mg carboxymethyl cellulose once a day produced by Baryj Essence pharmaceutical company, orally for 6 months. Intervention group 3: One Nigella Sativa oil soft-gel capsule 1000 mg once a day prepared by Baryj Essence pharmaceutical company and one Curcumin soft-gel capsule containing 80 mg Curcumin as nanomicelle once a day prepared by Exir Nano Sina company, orally for 6 months. Control group: One Nigella Sativa placebo soft-gel capsule containing 1000 mg carboxymethyl cellulose once a day prepared by Baryj Essence pharmaceutical companyand one Curcumin placebo capsule containing 80 mg carboxymethyl cellulose once a day prepared by Exir Nano Sina company, orally for 6 months. Bone mineral density. Timepoint: At the baseline (before intervention) and just after completion of the intervention (6 months after beginning the intervention ). Method of measurement: Dual-energy X-ray absorptiometry (DXA). Serum levels of bone turnover markers (Osteocalcin، Osteopontin, Total Alkaline Phosphatase). Timepoint: At the baseline (before intervention) and just after completion of the intervention (6 months after beginning of intervention ). Method of measurement: Using the ELISA method. Serum levels of some inflammatory factors (TNF-α, hs-CRP, IL-6). Timepoint: At the baseline (before intervention) and just after completion of the intervention (6 months after beginning of intervention ). Method of measurement: Using calorie meter and ELISA method. Serum levels of osteoporosis MicroRNA (miR422a، miR-133a، miR-21 و miR-503). Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention ). Method of measurement: Using the Real-Time PCR method. Quality of life score. Timepoint: At the baseline (before intervention) and 1,3, and 6 months after beginning intervention. Method of measurement: Using the MENQOL questionnaire. Body composition analysis score (PBF, MBF, SLM, LBM, VFM, TBW, Mineral). Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention). Method of measurement: Body Composition Analyzer. The 10-year probability of fracture. Timepoint: At the baseline (before intervention) and completion of intervention (6 months after beginning of study). Method of measurement: Fracture Risk Assessment Tool (FRAX). Serum levels of some oxidative stress indices (TAC, SOD, MDA). Timepoint: At the baseline (before intervention) and just after completion of the intervention (6 months after beginning of intervention ). Method of measurement: Using Spectrophotometer and ELISA method. Serum levels of Insulin-like Growth Factor-I and binding proteins (TAC, SOD, MDA). Timepoint: At the baseline (before intervention) and completion of intervention (6 months after beginning of study). Method of measurement: Using Spectrophotometer and ELISA method. Lipid profile. Timepoint: At the baseline (before the intervention) and completion of the intervention (6 months after the beginning of the study). Method of measurement: biochemical methods. Glycemic control indices. Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after the beginning of the study. Method of measurement: biochemical methods. Serum 17-β estradiol. Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after the beginning of the study. Method of measurement: Using ELISA method. Tabriz University of Medical Sciences Approved 2018-05-14 Ethics committee of Tabriz University of Medical Sciences Research Vice-chancellor of Tabriz University of Medical Sciences., End of Gholgasht Ave., Tabriz., Iran Tabriz East Azarbaijan Iran (Islamic Republic of)