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The effect of oral capsule curcumin and vitamin E in comparison to placebo on serum levels of some antioxidants and inflammatory factors in postmenopausal women: A randomized, triple-controlled clinical trial.

Phase 3
Conditions
Condition 1: TAC (Total Antioxidant Capacity). Condition 2: (Malondialdehyde) MDA. Condition 3: hsCRP (high sensitivity C-Reactive Protein). Condition 4: Early symptoms of manopause.
Registration Number
IRCT20131009014957N6
Lead Sponsor
Tabriz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
93
Inclusion Criteria

1) Readiness to participate in the study
2) Having sufficient literacy to complete the questionnaire or the presence of a literate person in the family
3) has normal menopause
4) Women who are less than 6 years old from their menopause.
5) having at least 40 years and a maximum of 60
6)Earn a minimum score of 15 and a maximum of 42 in the Green AssessmentHot flashes

Exclusion Criteria

1) Use of tobacco and alcohol and herbal medicines
2) Stress factors such as the death of first-degree relatives in the last 6 months and the loss of a job
3) Any acute and chronic inflammatory disease (including uncontrolled diabetes, rheumatoid arthritis) and infections in the body
4) The presence of malignant disease
5) History of recent surgery and trauma
6) History of allergy to turmeric or other drugs, food and color.
7) taking anticoagulants (heparin, varfarin, enoxaparin)
8) Take vitamin E supplementation, curcumin or estrogen therapy for 3 months prior to study
9) Use of special diets

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
(Total Antioxidant Capacity) TAC. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: TAC levels will be measured with the Biorex kit.;(Malondialdehyde) MDA. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Spectrophotometric and Atomic Absorption Comparison (AAS) will be measured.;HsCRP (high sensitivity C-Reactive Protein). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: A turbidometric method based on the formation of a complex resulting from the reaction between hs-CRP and its specific antiserum will be measured.;Score of Menopause symptoms and its sub-scales. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Green Questionnaire.
Secondary Outcome Measures
NameTimeMethod
Food intake. Timepoint: Before the intervention, one month after the intervention and at the end of the intervention. Method of measurement: 24-hour Food record.;Renal function tests. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Using biochemical methods.;Liver function tests. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Using biochemical methods.;?Serum lipid profile. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Using biochemical methods.;Fasting blood sugar. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Using biochemical methods.
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