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

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

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.

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.

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

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.

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

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 Modify and update the recruitment start and end dates

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.

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.