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IRCT20120718010324N72 IRCT 2022-10-18 Tabriz University of Medical Sciences The effect of curcumin on the fatigue and muscle soreness The effect of oral capsule of curcumin on the fatigue and muscle soreness in postmenopausal women: a randomized controlled trial 2022-10-21 anticipated 74 Complete https://irct.ir/trial/66151 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in the study will be assigned to two groups of intervention (recipient of curcumin capsule) and control (recipient of placebo) by block randomization method with block sizes of 4 and 6 and a allocation ratio of 1: 1 and using the website www.random.org . To hide the Allocation (Allocation Concealment), the allocation sequence will be identified by a person not involved in the study using a randomizer, and the curcumin and placebo will be placed in the same packages numbered sequentially, Blinding description: The participants, researcher and data analyst will be blinded completely in this study. Drug and placebo will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research. 3 Fatigue and muscle soreness. Intervention 1: Intervention group: The participants (37 people) will receive curcumin oral supplement in the form of tablets with a dose of 500 mg with the trade name (Curcuma ® ). The time to take the supplement will be twice a day and after meals. The duration of taking the drug will be 8 weeks from the time of administration. Intervention 2: Control group: The participants (37 people) will receive the placebo in the form of tablets with a dose of 500 mg. The placebo ingredients will consist of corn starch, which will be used at the same time as the curcumin supplement, twice a day and after meals. Also, the duration of taking the placebo will be 8 weeks from the time of administration. 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 Participant data is confidential.
public Sepideh Mashayekh Amiri
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
Tabriz Iran (Islamic Republic of) کدپستی: 977-5138947 +98 41 3479 6770 Sepidehmashayekh@yahoo.com Tabriz University of Medical Sciences scientific Dr. Mojgan Mirghafourvand
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
Tabriz Iran (Islamic Republic of) کدپستی: 977-5138947 +98 41 3479 6770 mirghafourvandm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Women with normal menopause At least one year after amenorrhea Sufficient literacy to complete the questionnaire or accompany a literate person in the family Age minimum 40 years and maximum 60 years 40 years 60 years Female Abuse of tobacco and alcohol Use of herbal medicines Occurrence of a stressful event (such as divorce, death of first-degree family members, diagnosis of incurable disease for a family member within the last three months, and loss of job) Psychiatric or systemic disorders (such as cardiovascular, digestive, hepatic, blood, endocrine, and gallstones) Taking any medication that affects hot flashes (clonidine, methyldopa, gabapentin, SSRIs, SNRIs, soy isoflavones), thyroid disease (as reported by women) Taking antidepressants (such as serotonin and noradrenaline reuptake inhibitors, antihistamines, barbiturates, narcotics, diazepam, amphetamines, and cocaine) History of allergy to turmeric or other drugs, allergy to certain foods and food dyes Taking anticoagulants such as heparin, aspirin, clopidogrel, dipyridamole, warfarin, enoxaparin and ticlopidine. Treatment - Drugs Placebo Intervention group: The participants (37 people) will receive curcumin oral supplement in the form of tablets with a dose of 500 mg with the trade name (Curcuma ® ). The time to take the supplement will be twice a day and after meals. The duration of taking the drug will be 8 weeks from the time of administration. Control group: The participants (37 people) will receive the placebo in the form of tablets with a dose of 500 mg. The placebo ingredients will consist of corn starch, which will be used at the same time as the curcumin supplement, twice a day and after meals. Also, the duration of taking the placebo will be 8 weeks from the time of administration. Fatigue. Timepoint: At the beginning of the study and 8 weeks after the start of consumption. Method of measurement: Short questionnaire of the perimenopausal fatigue scale. Muscle soreness. Timepoint: At the beginning of the study and 8 weeks after the start of consumption. Method of measurement: MUSCULOSKELETAL HEALTH QUESTIONNAIRE (MSK-HQ). Depression. Timepoint: At the beginning of the study and 8 weeks after the start of consumption. Method of measurement: Beck Depression Inventory (BDI-13). Tabriz University of Medical Sciences Approved 2022-09-19 Ethics committee of Tabriz University of Medical Sciences Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)