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Investigate the effect of Marrubium Vulgare dry powder of extract on Hormonal parameters and clinical finding in poly cystic ovarian syndrome

Protocol summary

Study aim
Investigate the effect of Marrubium Vulgare dry powder of extract on hormonal parameters and clinical finding in polycystic ovarian syndrome
Design
clinical trial with control group, three-way blind, randomized,with a sample size of 23 people in each group,phase 3, The study plan is N = 1, meaning that a patient is given a treatment such as active therapy or placebo for a short period of time.
Settings and conduct
This study is a three-way blind and randomized that will be performed on patients diagnosed with Polycystic Ovarian Syndrome who referred to the special clinic of Imam Reza hospital. envelopes containing 180 capsules.The 250 mg capsule intervention group will receive the marrubium vulgare twice a day for 2 months. and the placebo control group will receive the same dose as the intervention group.
Participants/Inclusion and exclusion criteria
Normal puberty, Ages between 18 and 35, Not pregnant, Lack of thyroid/adernal/pituitary and ovarian disorders, not using sex steroids, Not history of treatment or surgery for polycystic ovary syndrome
Intervention groups
In the intervention group,250 mg capsules containing the dry extract of marrubium vulgare will be prescribed twice a day for 2 month, and in the control group,similar capsules without herbal medicine will be prescribed in the same number and duration
Main outcome variables
In all patient, blood samples are collected at the beginning of the course and after the end of the treatment period, and the levels of testostron, estadiol and progestrone, as well as cholesterol, triglycerides and fasting blood sugar are evaluated (preliminary result). changes in acne, hirsutism, menstrual irregularities and changes in BMI before and after treatment are also evaluated (secondary out come)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200404046942N1
Registration date: 2020-04-29, 1399/02/10
Registration timing: prospective

Last update: 2020-04-29, 1399/02/10
Update count: 0
Registration date
2020-04-29, 1399/02/10
Registrant information
Name
Fatemeh Sargazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3651 9853
Email address
sargazif931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate the effect of Marrubium Vulgare dry powder of extract on Hormonal parameters and clinical finding in poly cystic ovarian syndrome
Public title
Investigate the effect of Marrubium Vulgare dry powder of extract on Hormonal parameters and clinical finding in poly cystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have a history of normal puberty Thyroid tests are normal Rotterdam criteria for polycystic ovarian syndrome The patients age is between 18 and 35 years Lack of thyroid disorders, Hyperprolactinemia, Hyper gonadotropic hypogonadism, Premature ovarian failure, Cushing´s syndroms, Congenital Adrenal Hyperplasia, Ovarian and Adrenal neoplasms and failure to develop physical illnesses Absence of pregnancy Lack of recent history of surgical treatment for Polycystic Ovarian Syndrome and treatment for Polycystic Ovarian Syndrome Do not use sex steroids(such as birth control pills, hormone therapy and androgenic drugs) and not use chemical and herbal medicines Do not use cigarettes and hookah
Exclusion criteria:
Being pregnant use of sex steroids Suffering from thyroid disorders, hyperprolactinemia, hypergonadotropic hypogonadism, premature ovarian failure, Cushing's syndrome, congenital adrenal hyperplasia, ovarian and adrenal neoplasms, physical illness Having a history of recent treatment for polycystic ovary syndrome Being under 18 years of age or over 35 years of age
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
The random assignment list will be created by computet(random number table using sites such as www.randomization.com or Excel software) and divided into two groups based on intervention and control. The method of the envelope is that the envelopes are prepared by a member of the research team and random numbers with the help of the site www.randomization.com and its printing is placed inside the envelope.the envelope door will be closed and its contents will not be visible from the outside,and then the petson will pick up an envelope and enter the control or intervention group based on its contents. The method of concealment of allocation is closed envelopes.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is a three-way blind clinical trial in which the subjects,observers and analysts did not know any of the individuals in the study groups.
Placebo
Used
Assignment
Other
Other design features
The design of this study is N = 1, which means that a patient is given a treatment such as active therapy or placebo for a short time

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad university of medical sciences
Street address
Deputy of Research and Technology, Qureshi Building, University street, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2020-02-18, 1398/11/29
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.895

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
In all patients, the level of testosterone is measured at the beginning of the visit and after the end of the treatment period.
Timepoint
At the begining of the patient´s visit and after the end of the two-month treatment period
Method of measurement
Using blood samples and radioimmunoassay

2

Description
In all patients, the level of estradiol is measured at the beginning of the visit and after the end of the treatment period.
Timepoint
At the beginning of the visit and after the end of the two-month treatment period
Method of measurement
Using blood samples and radioimmunoassay

3

Description
In all patients, the progesterone level is measured at the beginning and after the end of the treatment period
Timepoint
At the beginning of the visit and after the end of the two-month treatment period
Method of measurement
Using blood samples and radioimmunoassay

4

Description
In all patients, the amount of cholesterol is measured at the beginning and after the end of the treatment period
Timepoint
At the beginning of the visit and after the end of the two-month treatment period
Method of measurement
Blood sample

5

Description
In all patients, the amount of triglyceride is measured at the beginning of the visit and after the end of the treatment period.
Timepoint
At the beginning of the visit and after the end of the two-month treatment period
Method of measurement
blood sample

6

Description
In all patients, the amount of fasting blood sugar is measured at the beginning of the visit and after the end of the treatment period.
Timepoint
At the beginning of the visit and after the end of the two-month treatment period
Method of measurement
blood sample

Secondary outcomes

1

Description
Changes in acne progression before and after treatment are evaluated
Timepoint
At the beginning of the patient´s visit and after the end of the two-month treatment period
Method of measurement
Assessment of hirsutism is performed using its own scurvy

2

Description
Changes in menstrual irregularities are assessed
Timepoint
At the beginning of the visit and after the end of the two-month treatment period
Method of measurement
By calculating the menstrual cycle

3

Description
Changes in body mass index before and after treatment are evaluated
Timepoint
At the beginning of the visit and after the end of the two-month treatment period
Method of measurement
Using the formula for calculating body mass index

Intervention groups

1

Description
Intervention group: The intervention group will receive 250 mg capsules of marrubium vulgare plant twice a day for two months.These capsules are made by Mashhad School of Pharmacy.In order to prepare the capsules, the extract from marrubium vulgare plant is converted into granules and then The capsules are filled with granules
Category
Treatment - Drugs

2

Description
Control group: They will receive the placebo control group, which are similar capsules in terms of color with marrubium vulgare capsules and lack effective substance , with the same dose and method of use as the intervention group.The placebo will be provided by Mashhad School of Pharmacy
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital Special Clinic
Full name of responsible person
Dr. Maliha Afiat
Street address
Imam Reza Hospital Building, Imam Reza Square, Ibn Sina St., Mashhad, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@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
Vice Chancellor for Research and Technology, Qureshi Building, Daneshgah St., Mashhad, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@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
Fatemeh Sargazi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
4th floor, 14th unit,1th block, one saman residential complex, Shahrak Gharb, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3651 9853
Fax
Email
sargazif931@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Sargazi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
4th floor, 14th unit,1th block, one saman residential complex, Shahrak Gharb, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3651 9853
Fax
Email
sargazif931@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Sargazi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
4th floor, 14th unit,1th block, one saman residential complex, Shahrak Gharb, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3651 9853
Fax
Email
sargazif931@mums.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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