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The effect of oral capsule of curcumin on the fatigue and muscle soreness in postmenopausal women: a randomized controlled trial

Protocol summary

Study aim
To determine the effect of oral curcumin capsules on fatigue and muscle soreness in postmenopausal women
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 74 postmenopausal women. Blocked randomization method will be used for randomization.
Settings and conduct
The present study is a triple-blind randomized controlled trial (participant, researcher, outcome evaluator and data analyst will be unaware of the treatment received) that will be done in postmenopausal women referred to Sheikh Al-Raees Clinic and Psychiatry Clinic of Imam Reza Hospital in the city of Tabriz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with normal menopause; At least one year after amenorrhea; Sufficient literacy to complete the questionnaire or accompany a literate person in the family; Minimum age of 40 years and maximum of 60 years Exclusion criteria: Abuse of tobacco and alcohol; Use of herbal medicines; The occurrence of a stressful event; Psychiatric or systemic disorders; Taking any medication that affects hot flashes and thyroid disease; Taking antidepressants; History of allergy to turmeric or other drugs, allergy to certain foods and food colors; Taking anticoagulants
Intervention groups
Intervention group: Participants (37 women) will receive curcumin tablets with a dose of 500 mg twice a day after meals for 8 weeks. Control group: The Participants (37 women) will receive the placebo tablets with the same order as the intervention group.
Main outcome variables
Fatigue and muscle soreness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120718010324N72
Registration date: 2022-10-18, 1401/07/26
Registration timing: prospective

Last update: 2022-10-18, 1401/07/26
Update count: 0
Registration date
2022-10-18, 1401/07/26
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-21, 1401/07/29
Expected recruitment end date
2023-04-18, 1402/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral capsule of curcumin on the fatigue and muscle soreness in postmenopausal women: a randomized controlled trial
Public title
The effect of curcumin on the fatigue and muscle soreness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 40 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2022-09-19, 1401/06/28
Ethics committee reference number
IR.TBZMED.REC.1401.560

Health conditions studied

1

Description of health condition studied
Fatigue and muscle soreness
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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

2

Description
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)

Secondary outcomes

1

Description
Depression
Timepoint
At the beginning of the study and 8 weeks after the start of consumption
Method of measurement
Beck Depression Inventory (BDI-13)

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital and Sheikh Al Rais Clinic
Full name of responsible person
Zahra Mousavi
Street address
Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7059
Fax
+98 41 3335 2073
Email
imamreza@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3479 6969
Email
dabirkhanecent@tbzmed.ac.ir
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
Sepideh Mashayekh Amiri
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
کدپستی: 977-5138947
Phone
+98 41 3479 6770
Email
Sepidehmashayekh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
کدپستی: 977-5138947
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
کدپستی: 977-5138947
Phone
+98 41 3479 6770
Email
mirghafourvandm@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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