Comparison of the effect of chamomile and placebo on ovulation induction and hormonal parameters in patients with polycystic ovary syndrome
Design
This study is carried out on 70 women with polycystic ovary syndrome who are less than 38 years old. Randomization is done through providing envelopes each containing 180 capsules. These envelopes are numbered based on random allocation table by someone outside the study. Afterwards, envelopes are handed to the doctor to give them to patients in turn.
Settings and conduct
This is a double-blinded clinical trial in which researcher and patient are unaware of the type of intervention and it is carried out in Qaem and Imam Reza hospitals in Mashhad on 70 women with polycystic ovary syndrome. Participants will be randomly (through computerized randomization) divided into intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Normal maturation; Thyroid test is within normal range; Having Rotterdam criteria for polycystic ovary syndrome; Patient's age is between 18 and 35; Not having a recent history of surgical treatment and other treatment for polycystic ovary syndrome.
Exclusion criteria: Use of sex steroids (such as birth control pills, hormone therapy, androgenic drugs); Use of chemical or herbal medicine; Use of cigarettes or hookahs.
Intervention groups
Intervention group: patients daily receive two 500-mg chamomile capsules for 3 months.
Control group: patients daily receive two placebo capsules (which are similar to chamomile capsules in color but without effective ingredient) for 3 months.
Main outcome variables
Induction of ovulation; changes in hormonal parameter of total testosterone.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170315033085N3
Registration date:2018-06-16, 1397/03/26
Registration timing:registered_while_recruiting
Last update:2018-06-16, 1397/03/26
Update count:0
Registration date
2018-06-16, 1397/03/26
Registrant information
Name
malihe afiat
Name of organization / entity
Mashhad medical school
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2608
Email address
afiatm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-07, 1396/11/18
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of chamomile on ovulation induction and hormonal and clinical parameters in patients with polycystic ovary syndrome
Public title
Investigation of the effect of chamomile on ovulation induction in patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Normal maturation
Thyroid test is within normal range
Having Rotterdam criteria for polycystic ovary syndrome
Patient's age is between 18 and 35
Not having a recent history of surgical treatment and other treatment for polycystic ovary syndrome
Exclusion criteria:
Use of sex steroids (such as birth control pills, hormone therapy, androgenic drugs)
Use of chemical or herbal medicine
Use of cigarettes or hookahs
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done through providing drug-containing envelopes which are numbered based on random allocation table by someone outside the study. Afterwards, envelopes are handed to the doctor to give them to patients in turn.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blinded study in which researcher and patient are unaware of the type of intervention which means researcher and patient have no knowledge of the content of the envelope and treatment method.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Approval date
2017-11-07, 1396/08/16
Ethics committee reference number
IR.MUMS.fm.REC.1396.444
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Rate of ovulation induction in patients with polycystic ovary syndrome
Timepoint
Investigate of the ovarian follicles is done on 12th day of the first cycle and also on the 3rd and 12th days of the third cycle and in case of not having menstruation, at the end of 90th for all patinets.
Method of measurement
Transvaginal ultrasound
2
Description
total testostrone rate
Timepoint
measuring testostrone rate at the beginning of the study (before intervention) and at the end of the study
Method of measurement
ELISA method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients daily receive two 500-mg chamomile capsules for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Patients daily receive two placebo capsules (which are similar to chamomile capsules in color but without effective ingredient) with similar dose for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Malihe Afiat
Street address
Emam Reza hospital, Emam Reza Sq, Ebne-Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2609
Email
afiatm@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Azam Akbari Lor
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2477
Email
Akbarila941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Azam Akbari Lor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2477
Email
Akbarila941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Afiat
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza hospital, Emam Reza Sq, Ebne-Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2609
Email
afiatm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Afiat
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza hospital, Emam Reza Sq, Ebne-Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2609
Email
afiatm@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after patients are made unidentifiable
When the data will become available and for how long
Data can be accessible 6 months after results are published
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes
Under which criteria data/document could be used
Carrying out analysis on data is permitted
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.