Protocol summary
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Study aim
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Comparison of the effect of jujube and turmeric extract on serum adiponectin, sexual function and estradiol hormones profiling in the female
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Design
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Phase 2 clinical trial with control group and 15 people in each group, With parallel groups, placebo-controlled clinical trial, Simple individual randomization with envelope
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Settings and conduct
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A placebo-controlled randomized clinical trial in women of reproductive age 18 to 45 years with poor sexual function and moderate or high stress levels. Sampling method: After obtaining informed consent, purposeful sampling was performed among the female volunteers who referred to the centers and met the inclusion criteria.
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Participants/Inclusion and exclusion criteria
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be Persian and Farsi
Married and currently lives with her husband
Not currently pregnant or have child breastfeeding
dont be Infertile
dont have any Abortion and delivery of cesarean section
There is no history of medical problems such as diabetes and hypertension, psychological diseases, hip infections, pelvic pathological and other medical problems.
her contraceptive methods are not hormonal.
Over the past three months, they have not used drugs that interfere with sexual function.
have Normal BMI (between18.9 and24.9)
No use of special diets like vegetarianism
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Intervention groups
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Use of 300 mg turmeric extract capsules daily in women with poor sexual function and high moderate stress levels and the use of placebo in the control group
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Main outcome variables
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Sexual function. Steroid hormones
General information
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Reason for update
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After the study, the study was performed in triple- blinds.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190219042768N1
Registration date:
2021-06-10, 1400/03/20
Registration timing:
retrospective
Last update:
2021-07-22, 1400/04/31
Update count:
1
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Registration date
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2021-06-10, 1400/03/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-10-21, 1399/07/30
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Expected recruitment end date
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2021-04-21, 1400/02/01
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Actual recruitment start date
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2020-10-21, 1399/07/30
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Actual recruitment end date
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2021-04-21, 1400/02/01
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Trial completion date
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2021-04-21, 1400/02/01
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Scientific title
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Comparison of the effect of jujube and turmeric extract on serum adiponectin, sexual function and estradiol hormones profiling in the female population
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Public title
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Comparison of the effect of jujube and turmeric extract on serum adiponectin, sexual function and estradiol hormones profiling in the female population
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Purpose
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Basic scienece
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Inclusion/Exclusion criteria
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Inclusion criteria:
be Persian and Farsi
Married and currently lives with her husband
Not currently pregnant or have child breastfeeding
dont be Infertile
dont have any Abortion and delivery of cesarean section
There is no history of medical problems such as diabetes and hypertension, psychological diseases, hip infections, pelvic pathological and other medical problems.
her contraceptive methods are not hormonal.
Over the past three months, they have not used drugs that interfere with sexual function.
have Normal BMI (between 18.9 and 24.9)
No use of special diets like vegetarianism
Poor sexual function according to the FSFI questionnaire
Moderate to severe stress levels based on the DOS questionnaire
Exclusion criteria:
good sexual function
Mild stress
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Age
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From 19 years old to 45 years old
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Gender
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Female
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Phase
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1-2
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
30
Actual sample size reached:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization of an individual with an envelope in dividing the groups into two groups A and B. In this method, we selected a number of cards or letters as the intervention group and the same number of cards for the control group, then merged the cards together. One card was taken out and its allocation was recorded, and after the card was taken out, we returned it again to all the other cards. Then the cards are merged again and we take out another card. This process continues until a random sequence is reached according to the sample size.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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The present study is a triple-blind study and the researcher and the patient and analyst will be unaware of the treatment and grouping of the study. For this purpose, turmeric extract and placebo are encoded by another person. The main researcher intervenes patients in a triple-blind manner based on the code of drug packages. The drug code is recorded on the demographic information completion form. Intervention in the target group will be turmeric extract for 8 weeks at a rate of 300 kg / mg Placebo will be prepared in a similar way to turmeric extract without its effective ingredients. 8 weeks after using turmeric extract, again in women of both groups A venous blood sample will be taken.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-12, 1397/10/22
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Ethics committee reference number
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ir.modares.rec.1397.206
Health conditions studied
1
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Description of health condition studied
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sexual dysfunction
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ICD-10 code
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F52.8
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ICD-10 code description
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Other sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
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Description
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Sexual dysfunction.
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Timepoint
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before and after intervention
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Method of measurement
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questionnaire
2
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Description
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Steroidal hormones
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Timepoint
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before and after intervention
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Method of measurement
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laboratory kits
Intervention groups
1
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Description
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Intervention group: treatment with turmeric extract will be 300 mg for 4 weeks. This article has been extracted and concentrated by Dr. Elaheh Sadeghi under the supervision of Dr. Mohsen Sharifi, Professor, Department of Plant Physiology, Faculty of Basic Sciences, Tarbiat Modarres University, Iran
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Category
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Treatment - Drugs
2
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Description
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Control group: treatment by placebo, Placebo will be prepared in a similar way to turmeric extract without its effective ingredients. 4 weeks after using , women in both groups will have venous blood sampling again.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tarbiat modares univecity
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Only part of the information
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When the data will become available and for how long
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Access period starts 6 months after the results are published
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To whom data/document is available
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Scientific and research studies
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Under which criteria data/document could be used
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With sample permission
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From where data/document is obtainable
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E-mail
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What processes are involved for a request to access data/document
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Ethics Committee. Investigation proceedings
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Comments
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One week to one month