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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

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History
# Registration date Revision Id
3 2022-09-06, 1401/06/15 239276
2 2018-07-22, 1397/04/31 123394
1 2018-04-29, 1397/02/09 43908
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  • Protocol summary

    Determination of Ginger and turmeric supplementation effects on quality of life, body composition and osteoporosis related bio-markers and micro-RNAs in women with postmenopausal osteoporosis
    Determination of Ginger and turmeric supplementation effects on quality of life, body compositionو bone mineral density and osteoporosis related bio-markers and micro-RNAs in women with postmenopausal osteoporosis
    تعیین تأثیر مکمل زنجبیل و زردچوبه بر کیفیت زندگی، ترکیب بدنی و بیومارکر های سرمی و microRNA های مرتبط با پوکی استخوان در خانم‌های یائسه مبتلابه پوکی استخوان
    تعیین تأثیر مکمل زنجبیل و زردچوبه بر کیفیت زندگی، ترکیب بدنی، دانسیته استخوانی و بیومارکر های سرمی و microRNA های مرتبط با پوکی استخوان در خانم‌های یائسه مبتلابه پوکی استخوان
    This study is a randomized, triple-blind Phase 1 clinical trial in 100 women with postmenopausal osteoporosis. Participants will randomly be assigned into four groups to take ginger, curcumin, ginger and curcumin and placebo.
    This study is a randomized, triple-blind Phase 1 clinical trial in 120 women with postmenopausal osteoporosis. Participants will randomly be assigned into four groups.
    این مطالعه یک کارآزمایی بالینی تصادفی سه سو کور فاز 1 چهار ماهه بر روی 100 زن یائسه مبتلا به استئوپورز اولیه می باشد. شرکت کنندگان به صورت تصادفی به چهار گروه برای دریافت مکمل زنجبیل، زردچوبه، زنجبیل و زردچوبه و پلاسبو تخصیص داده می شوند.
    این مطالعه یک کارآزمایی بالینی تصادفی سه سو کور فاز 1 چهار ماهه بر روی 120 زن یائسه مبتلا به استئوپورز اولیه می باشد. شرکت کنندگان به صورت تصادفی به چهار گروه تخصیص داده می شوند.
    The target population are all women with postmenopausal osteoporosis referred to the specialized clinics of Tabriz University of Medical Sciences. Sampling will be done by convenience non randomized method. To conceal the allocation, the same envelope will be used in the opaque package to be numbered sequentially.
    The target population are all women with postmenopausal osteoporosis referred to the clinics of Tabriz University of Medical Sciences. Sampling will be done by convenience non randomized method. To conceal the allocation, the same envelope will be used in the opaque package to be numbered sequentially.
    جمعیت هدف کلیه زنان منو پوز مبتلا با استئوپورز بعد از یائسگی است که به کلینیک‌های تخصصی طب فیزیکی وابسته به دانشگاه علوم پزشکی تبریز مراجعه می‌کنند. نمونه گیری به روش غیرتصادفی در دسترس انجام خواهد شد. برای مخفی سازی تخصیص از پاکت های مشابه در بسته مات که پشت سر هم شماره گذاری شده اند استفاده خواهد شد.
    جمعیت هدف کلیه زنان منو پوز مبتلا با استئوپورز بعد از یائسگی است که به کلینیک‌های طب فیزیکی وابسته به دانشگاه علوم پزشکی تبریز مراجعه می‌کنند. نمونه گیری به روش غیرتصادفی در دسترس انجام خواهد شد. برای مخفی سازی تخصیص از پاکت های مشابه در بسته مات که پشت سر هم شماره گذاری شده اند استفاده خواهد شد.
    Quality of life; body composition; osteocalcin; procollagen type 1 amiNo-terminal propeptide; carboxy-Terminal cross-linked telopeptides of type 1 collagen; miR422a; miR-133a; miR-21 and miR-503
    Quality of life; body composition; osteocalcin; bone mineral density; procollagen type 1 amiNo-terminal propeptide; carboxy-Terminal cross-linked telopeptides of type 1 collagen; miR422a; miR-133a; miR-21 and miR-503
    کیفیت زندگی؛ ترکیب بدنی؛ استئوکلسین؛ پروپپتید انتهای آمینو پروکلاژن تیپ 1؛ تلوپپتید متقاطع انتهای کربوکسی کلاژن تیپ 1؛ سطوح در گردش miR422a؛ miR-133a؛ miR-21 و miR-503
    کیفیت زندگی؛ ترکیب بدنی؛ دانسیته استخوانی؛ استئوکلسین؛ پروپپتید انتهای آمینو پروکلاژن تیپ 1؛ تلوپپتید متقاطع انتهای کربوکسی کلاژن تیپ 1؛ سطوح در گردش miR422a؛ miR-133a؛ miR-21 و miR-503

  • General information

    100
    120
    2019-03-20, 1397/12/29
    2020-03-19, 1398/12/29
    empty
    Adding bone mineral densitometry as a primary outcome Increase sample size to gain sufficient study power Add coagulation disorders as an exclusion criterion Modify duration of intervention Extended sampling time
    empty
    اضافه کردن دانسیتومتری استخوانی به عنوان پیامد اولیه افزایش تعداد حجم نمونه جهت کسب توان کافی مطالعه اضافه کردن اختلالات انعقادی به عنوان معیار خروج اصلاح طول مدت مداخله تمدید زمان نمونه گیری
    Ginger (Zingiber officinale) and turmeric supplementation effects on quality of life, bone mass densitometry (BMD), body composition and osteoporosis related biomarkers and micro-RNAs in women with postmenoposal 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
    تأثیر مکمل زنجبیل و زردچوبه بر کیفیت زندگی، ترکیب بدنی و بیومارکر های سرمی و microRNA های مرتبط با استئوپورز در خانم‌های یائسه مبتلابه استئوپورز
    تأثیر مکمل زنجبیل و زردچوبه بر کیفیت زندگی، دانسیته استخوانی، ترکیب بدنی و بیومارکر های سرمی و microRNA های مرتبط با استئوپورز در خانم‌های یائسه مبتلابه استئوپورز
    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
    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
    استفاده از قرص ضدبارداری یا کورتون در طول مطالعه
    ابتلا به نارسایی و بیماری های کلیه
    ابتلا به بیماریهای متاستاتیک استخوانی
    مصرف داروهای اثرگذار بر متابولیسم استخوان به غیر از مصرف مکملهای کلسیم-دی و آلندرونات که با دوز یکسان به تمام بررسی شوندگان تجویز می‌شود
    ابتلا به بدخیمی
    استفاده از قرص ضدبارداری یا کورتون در طول مطالعه
    ابتلا به نارسایی و بیماری های کلیه
    ابتلا به بیماریهای متاستاتیک استخوانی
    مصرف داروهای اثرگذار بر متابولیسم استخوان به غیر از مصرف مکملهای کلسیم-دی و آلندرونات که با دوز یکسان به تمام بررسی شوندگان تجویز می‌شود
    ابتلا به بدخیمی
    اختلالات انعقادی
    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 100. The first envelope will be given to the first person who will be included in the study and will continue to complete the sampling.
    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.
    برای مخفی سازی تخصیص از پاکت های مشابه در بسته مات که پشت سر هم شماره گذاری شده اند استفاده خواهد شد. بنابراین هیچ کدام از افراد شرکت کننده، پژوهشگر و تحلیل کننده آماری از نوع مداخله دریافتی اطلاع نخواهند یافت. پاکت از 1 تا 100 شماره گذاری خواهند شد. اولین پاکت به اولین فردی که وارد مطالعه می شود داده خواهد شد و تا تکمیل نمونه گیری این روند ادامه خواهد یافت.
    برای مخفی سازی تخصیص از پاکت های مشابه در بسته مات که پشت سر هم شماره گذاری شده اند استفاده خواهد شد. بنابراین هیچ کدام از افراد شرکت کننده، پژوهشگر و تحلیل کننده آماری از نوع مداخله دریافتی اطلاع نخواهند یافت. پاکت از 1 تا 120شماره گذاری خواهند شد. اولین پاکت به اولین فردی که وارد مطالعه می شود داده خواهد شد و تا تکمیل نمونه گیری این روند ادامه خواهد یافت.

  • Primary outcomes

    #1
    Evaluating the quality of life at the beginning of the study (before the intervention) and 6 months after the intervention began
    Evaluating the quality of life at the beginning of the study (before the intervention) and 4 months after the intervention began
    ارزیابی کیفیت زندگی در ابتدای مطالعه (قبل از شروع مداخله) و 6 ماه پس از شروع مداخله
    ارزیابی کیفیت زندگی در ابتدای مطالعه (قبل از شروع مداخله) و 4 ماه پس از شروع مداخله
    #2
    Evaluating the Body composition at the beginning of the study (before the intervention) and 6 months after the intervention began
    Evaluating the Body composition at the beginning of the study (before the intervention) and 4 months after the intervention began
    ارزیابی ترکیب بدنی در ابتدای مطالعه (قبل از شروع مداخله) و 6 ماه پس از شروع مداخله
    ارزیابی ترکیب بدنی در ابتدای مطالعه (قبل از شروع مداخله) و 4 ماه پس از شروع مداخله
    #3
    Osteocalcin
    Bone mineral density
    استئوکلسین
    دانسیته استخوان
    Measuring serum osteocalcin at the beginning of the study (before the intervention) and 6 months after the intervention began
    Measuring serum Bone mineral density at the beginning of the study (before the intervention) and 4 months after the intervention began
    اندازه گیری سطح سرمی استئوکلسین در ابتدای مطالعه (قبل از شروع مداخله) و 6 ماه پس از شروع مداخله
    اندازه گیری دانسیته استخوان در ابتدای مطالعه (قبل از شروع مداخله) و 4 ماه پس از شروع مداخله
    Biochemical assay
    Dual X-ray absorptiometry (DXA)
    اندازه گیری بیوشیمیایی
    روش جذب اشعه ايکس با انرژي دوگانه
    #4
    Procollagen type 1 amiNo-terminal Propeptide
    empty
    پپتید انتهای آمینو پروکلاژن تیپ 1
    empty
    Measuring serum Procollagen type 1 amiNo-terminal Propeptide at the beginning of the study (before the intervention) and 6 months after the intervention began
    empty
    اندازه گیری سطح سرمی پپتید انتهای آمینو پروکلاژن تیپ 1 در ابتدای مطالعه (قبل از شروع مداخله) و 6 ماه پس از شروع مداخله
    empty
    Biochemical assay
    empty
    اندازه گیری بیوشیمیایی
    empty
    #5
    Caboxy-Terminal cross-linked telopeptides of type 1 collagen
    empty
    تلوپپتید متقاطع انتهای کربوکسی کلاژن تیپ 1
    empty
    Measuring serum Caboxy-Terminal cross-linked telopeptides of type 1 collagen at the beginning of the study (before the intervention) and 6 months after the intervention began
    empty
    اندازه گیری سطح سرمی تلوپپتید متقاطع انتهای کربوکسی کلاژن تیپ 1 در ابتدای مطالعه (قبل از شروع مداخله) و 6 ماه پس از شروع مداخله
    empty
    Biochemical assay
    empty
    اندازه گیری بیوشیمیایی
    empty
    #6
    miR-422a (micro-RNA)
    empty
    میکرو آر ان آ miR-422a
    empty
    Measuring serum miR-422a (micro-RNA) at the beginning of the study (before the intervention) and 6 months after the intervention began
    empty
    اندازه گیری سطح سرمی میکرو آر ان آ miR-422a در ابتدای مطالعه (قبل از شروع مداخله) و 6 ماه پس از شروع مداخله
    empty
    Biochemical assay
    empty
    اندازه گیری بیوشیمیایی
    empty
    #7
    miR-133a (micro-RNA)
    empty
    میکرو آر ان آ miR-133a
    empty
    Measuring serum miR-133a (micro-RNA) at the beginning of the study (before the intervention) and 6 months after the intervention began
    empty
    اندازه گیری سطح سرمی میکرو آر ان آ miR-133a در ابتدای مطالعه (قبل از شروع مداخله) و 6 ماه پس از شروع مداخله
    empty
    Biochemical assay
    empty
    اندازه گیری بیوشیمیایی
    empty
    #8
    miR-21 (micro-RNA)
    empty
    میکرو آر ان آ miR-21
    empty
    Measuring serum miR-21 (micro-RNA) at the beginning of the study (before the intervention) and 6 months after the intervention began
    empty
    اندازه گیری سطح سرمی میکرو آر ان آ miR-21 در ابتدای مطالعه (قبل از شروع مداخله) و 6 ماه پس از شروع مداخله
    empty
    Biochemical assay
    empty
    اندازه گیری بیوشیمیایی
    empty
    #9
    MiR-503 (micro-RNA)
    empty
    میکرو آر ان آ MiR-503
    empty
    Measuring serum MiR-503 (micro-RNA) at the beginning of the study (before the intervention) and 6 months after the intervention began
    empty
    اندازه گیری سطح سرمی میکرو آر ان آ MiR-503 در ابتدای مطالعه (قبل از شروع مداخله) و 6 ماه پس از شروع مداخله
    empty
    Biochemical assay
    empty
    اندازه گیری بیوشیمیایی
    empty

  • Secondary outcomes

    #1
    empty
    Osteocalcin
    empty
    استئوکلسین
    empty
    Measuring serum osteocalcin at the beginning of the study (before the intervention) and 4 months after the intervention began
    empty
    اندازه گیری سطح سرمی استئوکلسین در ابتدای مطالعه (قبل از شروع مداخله) و 4 ماه پس از شروع مداخله
    empty
    Biochemical assay
    empty
    اندازه گیری بیوشیمیایی
    #2
    empty
    Procollagen type 1 amiNo-terminal Propeptide
    empty
    پپتید انتهای آمینو پروکلاژن تیپ 1
    empty
    Measuring serum Procollagen type 1 amiNo-terminal Propeptide at the beginning of the study (before the intervention) and 6 months after the intervention began
    empty
    اندازه گیری سطح سرمی پپتید انتهای آمینو پروکلاژن تیپ 1 در ابتدای مطالعه (قبل از شروع مداخله) و 4 ماه پس از شروع مداخله
    empty
    Biochemical assay
    empty
    اندازه گیری بیوشیمیایی
    #3
    empty
    Caboxy-Terminal cross-linked telopeptides of type 1 collagen
    empty
    تلوپپتید متقاطع انتهای کربوکسی کلاژن تیپ 1
    empty
    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
    empty
    اندازه گیری سطح سرمی تلوپپتید متقاطع انتهای کربوکسی کلاژن تیپ 1 در ابتدای مطالعه (قبل از شروع مداخله) و 4 ماه پس از شروع مداخله
    empty
    Biochemical assay
    empty
    اندازه گیری بیوشیمیایی
    #4
    empty
    miR-422a (micro-RNA)
    empty
    میکرو آر ان آ miR-422a
    empty
    Measuring serum miR-422a (micro-RNA) at the beginning of the study (before the intervention) and 4 months after the intervention began
    empty
    اندازه گیری سطح سرمی میکرو آر ان آ miR-422a در ابتدای مطالعه (قبل از شروع مداخله) و 4 ماه پس از شروع مداخله
    empty
    Biochemical assay
    empty
    اندازه گیری بیوشیمیایی
    #5
    empty
    miR-133a (micro-RNA)
    empty
    میکرو آر ان آ miR-133a
    empty
    Measuring serum miR-133a (micro-RNA) at the beginning of the study (before the intervention) and 4 months after the intervention began
    empty
    اندازه گیری سطح سرمی میکرو آر ان آ miR-133a در ابتدای مطالعه (قبل از شروع مداخله) و 4 ماه پس از شروع مداخله
    empty
    Biochemical assay
    empty
    اندازه گیری بیوشیمیایی
    #6
    empty
    miR-21 (micro-RNA)
    empty
    میکرو آر ان آ miR-21
    empty
    Measuring serum miR-21 (micro-RNA) at the beginning of the study (before the intervention) and 4 months after the intervention began
    empty
    اندازه گیری سطح سرمی میکرو آر ان آ miR-21 در ابتدای مطالعه (قبل از شروع مداخله) و 4 ماه پس از شروع مداخله
    empty
    Biochemical assay
    empty
    اندازه گیری بیوشیمیایی
    #7
    empty
    MiR-503 (micro-RNA)
    empty
    میکرو آر ان آ MiR-503
    empty
    Measuring serum MiR-503 (micro-RNA) at the beginning of the study (before the intervention) and 4 months after the intervention began
    empty
    اندازه گیری سطح سرمی میکرو آر ان آ MiR-503 در ابتدای مطالعه (قبل از شروع مداخله) و 4 ماه پس از شروع مداخله
    empty
    Biochemical assay
    empty
    اندازه گیری بیوشیمیایی

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Neda Dolatkhah
    Full name of responsible person - Persian: ندا دولت خواه
    Street address - English: Physical Medicine and Rehabilitation Research Center, Emam Reza Hospital, Golghasht, Azadi Ave.
    Street address - Persian: خیابان آزادی، خیابان گلگشت، بیمارستان امام رضا (ع)، مرکز تحقیقات طب فیزیکی و توان بخشی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614756
    Phone: +98 41 3336 1928
    Fax:
    Email: dolatkhahn@tbzmed.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Abolghasem Jouyban
    Full name of responsible person - Persian: ابوالقاسم جویبان
    Street address - English: Vice Chancellor for Research (VCR), Third Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Ave.
    Street address - Persian: خیابان گلگشت، دانشگاه علوم پزشکی تبریز، ساختمان مرکزی شماره 2، طبقه سوم، معاونت تحقیقات و فناوری
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614756
    Phone: +98 41 3334 1249
    Fax:
    Email: ajouyban@hotmail.com
    Web page address:

Protocol summary

Study aim
Determination of Ginger and turmeric supplementation effects on quality of life, body compositionو bone mineral density and osteoporosis related bio-markers and micro-RNAs in women with postmenopausal osteoporosis
Design
This study is a randomized, triple-blind Phase 1 clinical trial in 120 women with postmenopausal osteoporosis. Participants will randomly be assigned into four groups.
Settings and conduct
The target population are all women with postmenopausal osteoporosis referred to the clinics of Tabriz University of Medical Sciences. Sampling will be done by convenience non randomized method. To conceal the allocation, the same envelope will be used in the opaque package to be numbered sequentially.
Participants/Inclusion and exclusion criteria
Inclusion criteria include natural menopause; age 45 and above; low bone density (Score T minus 2.5 and lower) and no history of fracture. Exclusion criteria include the use of birth control pills or steroids during the study; renal failure; metastatic bone disease; taking medications that affect bone metabolism other than taking calcium-D supplements and alendronate that are given to all subjects with the same dose
Intervention groups
Participants will be randomly divided into four groups to receive 1) Ginger supplement 2) Turmeric supplement 3) Ginger-Turmeric supplement and 4) Placebo. In group 1, one capsule of 1000 mg of ginger and two placebo of turmeric, in group 2, two capsules of 500 mg of turmeric and one placebo of ginger, in group 3, three capsules (two turmeric capsules and one ginger capsule), and Group 4 will receive three capsules of placebo.
Main outcome variables
Quality of life; body composition; osteocalcin; bone mineral density; procollagen type 1 amiNo-terminal propeptide; carboxy-Terminal cross-linked telopeptides of type 1 collagen; miR422a; miR-133a; miR-21 and miR-503

General information

Reason for update
Adding bone mineral densitometry as a primary outcome Increase sample size to gain sufficient study power Add coagulation disorders as an exclusion criterion Modify duration of intervention Extended sampling time
Acronym
IRCT registration information
IRCT registration number: IRCT20161022030424N3
Registration date: 2018-04-29, 1397/02/09
Registration timing: registered_while_recruiting

Last update: 2020-02-25, 1398/12/06
Update count: 2
Registration date
2018-04-29, 1397/02/09
Registrant information
Name
Neda Dolatkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 1928
Email address
dolatkhahn@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-03, 1397/01/14
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Ginger (Zingiber officinale) and turmeric supplementation effects in osteoporosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 45 years old
Gender
Female
Phase
0
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Regional Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice Chancellor for Research, Tabriz University of Medical Sciences, Golgasht Str.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2017-11-06, 1396/08/15
Ethics committee reference number
IR.TBZMED.REC.1396.720

Health conditions studied

1

Description of health condition studied
Postmenopausal osteoporosis
ICD-10 code
M81.0
ICD-10 code description
Postmenopausal osteoporosis

Primary outcomes

1

Description
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

2

Description
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

3

Description
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)

Secondary outcomes

1

Description
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

2

Description
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

3

Description
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

4

Description
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

5

Description
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

6

Description
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

7

Description
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

Intervention groups

1

Description
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
Category
Treatment - Other

2

Description
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
Category
Treatment - Other

3

Description
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
Category
Treatment - Other

4

Description
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
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Neda Dolatkhah
Street address
Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
dolatkhahn@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Vice Chancellor for Research (VCR), Third Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 1249
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
dolatkhahn@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
dolatkhahn@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
dolatkhahn@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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