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IRCT20161022030424N3 IRCT 2018-04-29 Tabriz University of Medical Sciences Ginger (Zingiber officinale) and turmeric supplementation effects in osteoporosis Ginger (Zingiber officinale) and turmeric supplementation effects on quality of life, bone mineral density, body composition and osteoporosis related biomarkers and micro-RNAs in women with postmenoposal osteoporosis 2018-05-01 anticipated 120 Complete https://irct.ir/trial/30213 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For random allocation of study participants to study groups, computer software RAS (Random Allocation Software) will be used through 4 and 8 glass block and allocation ratio of 1: 1, Blinding description: For concealment of the allocation, the same envelopes will be used in the opaque package to be numbered sequentially. Therefore, no participant, researcher, and statistical analyst will be aware of the type of intervention received. Envelopes will be numbered from 1 to 120. The first envelope will be given to the first person who will be included in the study and will continue to complete the sampling. 0 (exploratory trials) Postmenopausal osteoporosis. Intervention 1: Intervention group: Vomigone tablets manufactured by Dinah's pharmaceutical company containing 470 ± 30 mg of standarized rhizome powdered of ginger (Zingiber officinale) twice-daily with a meal in addition Curcuma placebo tablets manufactured by Dinah's pharmaceutical company, which are in shape, size, taste, smell and other appearance characteristics, are quite similar to the curcuma tablet and are free of powdered and turmeric extract twice-daily with a meal for 4 months. Intervention 2: Intervention group: Curcuma tablets manufactured by Dinah's pharmaceutical company containing 450 mg of turmeric rhizome and 50 mg of turmeric extract twice-daily with a meal for 4 months in addition Vomigone placebo tablets manufactured by Dinah's pharmaceutical company, which are in shape, size, taste, smell and other appearance characteristics, are quite similar to the Vomigone tablet and are free of powdered ginger twice-daily with a meal for 4 months. Intervention 3: Intervention group: Vomigone tablets manufactured by Dinah's pharmaceutical company containing 470 ± 30 mg of standarized rhizome powdered of ginger (Zingiber officinale) twice-daily with a meal in addition Curcuma tablets manufactured by Dinah's pharmaceutical company containing 450 mg of turmeric rhizome and 50 mg of turmeric extract twice-daily with a meal for 4 months. Intervention 4: Control group: Vomigone placebo tablets manufactured by Dinah's pharmaceutical company, which are in shape, size, taste, smell and other appearance characteristics, are quite similar to the Vomigone tablet and are free of powdered ginger twice-daily with a meal in addition Curcuma placebo tablets manufactured by Dinah's pharmaceutical company, which are in shape, size, taste, smell and other appearance characteristics, are quite similar to the curcuma tablet and are free of powdered and turmeric extract twice-daily with a meal for 4 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Neda Dolatkhah
Golgasht Str., Azadi Ave.
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3336 1928 dolatkhahn@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Neda Dolatkhah
Golgasht Str., Azadi Ave.
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3336 1928 dolatkhahn@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Natural menopause Age 45 and above Menstrual cessation for 12 consecutive months low bone density (Score T minus 2.5 and lower) No history of fracture 45 years no limit Female Use Contraceptive Pills or Corticostroids During Study Kidney disease or failure Metastatic bone disease Taking medications that affect bone metabolism other than taking calcium-D supplements or Alendronate that are given to all subjects with the same dose. Malignancy coagulation disorders M81.0 Postmenopausal osteoporosis Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group: Vomigone tablets manufactured by Dinah's pharmaceutical company containing 470 ± 30 mg of standarized rhizome powdered of ginger (Zingiber officinale) twice-daily with a meal in addition Curcuma placebo tablets manufactured by Dinah's pharmaceutical company, which are in shape, size, taste, smell and other appearance characteristics, are quite similar to the curcuma tablet and are free of powdered and turmeric extract twice-daily with a meal for 4 months Intervention group: Curcuma tablets manufactured by Dinah's pharmaceutical company containing 450 mg of turmeric rhizome and 50 mg of turmeric extract twice-daily with a meal for 4 months in addition Vomigone placebo tablets manufactured by Dinah's pharmaceutical company, which are in shape, size, taste, smell and other appearance characteristics, are quite similar to the Vomigone tablet and are free of powdered ginger twice-daily with a meal for 4 months Intervention group: Vomigone tablets manufactured by Dinah's pharmaceutical company containing 470 ± 30 mg of standarized rhizome powdered of ginger (Zingiber officinale) twice-daily with a meal in addition Curcuma tablets manufactured by Dinah's pharmaceutical company containing 450 mg of turmeric rhizome and 50 mg of turmeric extract twice-daily with a meal for 4 months Control group: Vomigone placebo tablets manufactured by Dinah's pharmaceutical company, which are in shape, size, taste, smell and other appearance characteristics, are quite similar to the Vomigone tablet and are free of powdered ginger twice-daily with a meal in addition Curcuma placebo tablets manufactured by Dinah's pharmaceutical company, which are in shape, size, taste, smell and other appearance characteristics, are quite similar to the curcuma tablet and are free of powdered and turmeric extract twice-daily with a meal for 4 months Quality of life. Timepoint: Evaluating the quality of life at the beginning of the study (before the intervention) and 4 months after the intervention began. Method of measurement: The Menopause Specific Quality of Life Questionnaire. Body composition. Timepoint: Evaluating the Body composition at the beginning of the study (before the intervention) and 4 months after the intervention began. Method of measurement: Body composition analyzer. Bone mineral density. Timepoint: Measuring serum Bone mineral density at the beginning of the study (before the intervention) and 4 months after the intervention began. Method of measurement: Dual X-ray absorptiometry (DXA). Osteocalcin. Timepoint: Measuring serum osteocalcin at the beginning of the study (before the intervention) and 4 months after the intervention began. Method of measurement: Biochemical assay. Procollagen type 1 amiNo-terminal Propeptide. Timepoint: Measuring serum Procollagen type 1 amiNo-terminal Propeptide at the beginning of the study (before the intervention) and 6 months after the intervention began. Method of measurement: Biochemical assay. Caboxy-Terminal cross-linked telopeptides of type 1 collagen. Timepoint: Measuring serum Caboxy-Terminal cross-linked telopeptides of type 1 collagen at the beginning of the study (before the intervention) and 4 months after the intervention began. Method of measurement: Biochemical assay. MiR-422a (micro-RNA). Timepoint: Measuring serum miR-422a (micro-RNA) at the beginning of the study (before the intervention) and 4 months after the intervention began. Method of measurement: Biochemical assay. MiR-133a (micro-RNA). Timepoint: Measuring serum miR-133a (micro-RNA) at the beginning of the study (before the intervention) and 4 months after the intervention began. Method of measurement: Biochemical assay. MiR-21 (micro-RNA). Timepoint: Measuring serum miR-21 (micro-RNA) at the beginning of the study (before the intervention) and 4 months after the intervention began. Method of measurement: Biochemical assay. MiR-503 (micro-RNA). Timepoint: Measuring serum MiR-503 (micro-RNA) at the beginning of the study (before the intervention) and 4 months after the intervention began. Method of measurement: Biochemical assay. Tabriz University of Medical Sciences Approved 2017-11-06 Regional Ethics Committee of Tabriz University of Medical Sciences Vice Chancellor for Research, Tabriz University of Medical Sciences, Golgasht Str. Tabriz East Azarbaijan Iran (Islamic Republic of)