Protocol summary
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Study aim
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evaluate the effects of herbal Mixture in infertile women with Polycystic ovary syndrome (PCOS).
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Design
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This single-blind randomized clinical trial the participants were divided into three groups (g1: Clomiphene Citrate (CC); g2: herbal mixture; and g3: herbal mixture along with (CC) by random allocation software through randomized blocks of three and six with an allocation ratio of 1:1:1. For allocation concealment, according to sequence generation opaque and sealed envelopes No; each contain a letter designating the allocation. The 1envelope was dedicated to 1 participant and this process was followed to the end of the research.ample size was calculated based on three variables of MDA, Testosterone and HOMA-IR.
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Settings and conduct
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it was done in alzahra hospital ,TBZMED. All participants were informed about the purpose of the study, and an informed consent was obtained from each of them.
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Participants/Inclusion and exclusion criteria
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Inclusion: willing to participate in the study, having at least two out of three of the Rotterdam criteria (2003) for the diagnosis of PCOS, aged between 18–35 years old, having BMI less than 30, not receiving any treatment at least in the last 3 months.Exclusion: diabetes mellitus, use of medications such as those helping ovulation or insulin sensitizers, thyroid disorders, cholesterol-lowering drugs, smoking, Hypertension, cardiovascular diseases, Cushing syndrome, allergy to Mentha spicata , Zingiber officinale , Cinnamomum zeylanicum and Citrus Sinensis
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Intervention groups
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clomiphene citrate group from third- fifth day of menstruation for five days for three menstrual cycles; herbal mixture capsule group, herbal mixture capsule group along with CC for 3 months
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Main outcome variables
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Primary outcomes included serum levels of antioxidants blood biomarkers and sex hormones.Thyroid hormones and clinical features were considered as secondary outcomes.
General information
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Reason for update
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It was requested that some sections that were incomplete be completed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201509295563N7
Registration date:
2016-01-09, 1394/10/19
Registration timing:
registered_while_recruiting
Last update:
2020-01-16, 1398/10/26
Update count:
1
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Registration date
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2016-01-09, 1394/10/19
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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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Vice chancellor for Research,Tabriz University Of Medical Sciences
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Expected recruitment start date
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2015-10-23, 1394/08/01
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Expected recruitment end date
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2016-10-22, 1395/08/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the efficacy of herbal medicine (Mixture) with Clomiphene citrate in treatment of Poly-cystic ovary syndrome (PCOS) and fertility rate in infertile women referring toTabriz Al-Zahra hospital.
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Public title
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The effects of herbal mixture in infertile women with Polycystic ovary syndrome (PCOS): a randomized controlled trial
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
willing to participate in the study
having at least two out of three of the Rotterdam criteria (2003) for the diagnosis of PCOS
aged between 18–35 years old
having body mass index (BMI) less than 30
not receiving any treatment at least in the last 3 months (wash out)
Exclusion criteria:
patients with diabetes mellitus
use of medications such as those helping ovulation or insulin sensitizers
thyroid disorders
cholesterol-lowering drugs
smoking
hypertension
cardiovascular diseases
Cushing syndrome
allergy to Mentha spicata (spearmint), Zingiber officinale (ginger) ,Cinnamomum zeylanicum (cinnamon), and Citrus Sinensis (sweet orange)
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
102
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The participants were divided into three groups (group 1: Clomiphene Citrate (CC); group 2: herbal mixture; and group 3: herbal mixture along with (CC) by random allocation software through randomized blocks of three and six with an allocation ratio of 1:1:1. For allocation concealment, according to sequence generation opaque and sealed envelopes numbered; each contain a letter designating the allocation. The first envelope was dedicated to first participant and this process was followed to the end of the research.Only the statistician was blind to the study.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The statistician was blind to the study.
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Placebo
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Not 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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2015-10-03, 1394/07/11
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Ethics committee reference number
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TBZMED.REC.1394.576
Health conditions studied
1
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Description of health condition studied
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Female infertility
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ICD-10 code
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N97.0
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ICD-10 code description
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Female infertility associated with anovulation
Primary outcomes
1
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Description
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Treatment of ovarian cysts
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Timepoint
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Before the intervention, three months after intervention
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Method of measurement
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Ultrasound of the ovaries (ovarian size, number and size of follicles)
Secondary outcomes
1
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Description
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Pregnancy
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Timepoint
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3 months after taking medicinal plants (Citro Plus)
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Method of measurement
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Positive BhcG
Intervention groups
1
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Description
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" :Intervention group: " herbal medicine (Mixture) 700 mgs/day continuous for 3 cycles.
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Category
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Treatment - Drugs
2
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Description
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"Control group" Clomiphene Citrate 50-150 mg for 3 cycles
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Category
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Treatment - Drugs
3
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Description
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'' :Intervention group: " herbal medicine (Mixture) 700 mgs/day continuous with Clomiphene Citrate 50-150 mg for 3 cycles.
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Category
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Treatment - Drugs
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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Vice chancellor for Research,Tabriz University Of Medical Sciences
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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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Private
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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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Other
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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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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age of patient
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When the data will become available and for how long
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September 2019
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To whom data/document is available
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Academic member of universities
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Under which criteria data/document could be used
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Ministry of Health and education
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From where data/document is obtainable
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Womens Reproductive Health Research Center Tabriz University of Medical sciences , Dr Nava Ainehchi 00984135541221
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What processes are involved for a request to access data/document
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Direct Contact to Womens Reproductive Health Research Center Tabriz University of Medical sciences- 2 months
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Comments
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