Comparison of the effect of lavender and Metformin on Polycystic ovary syndrome
Design
The Clinical trial will be Open label. Patients will be 68 people. Patients were divided into two random groups: How to randomize Block randomization will be done in the form of 4 blocks.
Settings and conduct
After the diagnostic test was performed And based on ultrasound, polycystic ovaries were confirmed for them According to the randomization table in one of the groups of lavender capsules or metformin tablets After taking the drug for three months, the menstrual pattern of the people is examined and if it becomes regular, Serum progesterone levels in the luteal phase will be measured by referral to a laboratory.
Participants/Inclusion and exclusion criteria
Entry requirements:
Diagnosis of Poly cystic ovary syndrome by a Gynecologist
Do not take Diabetes medications, Hyper lipidemia medications, or Blood
pressure medications
No entry conditions:
No Pregnancy or Breastfeeding
Do not take Insulin sensitizers
Do not take Aspirin or other Anticoagulants
Do not take Anti-prostaglandin drugs
Do not take other Herbal medicines at the same time for your disease
No history of uncontrolled blood pressure, stroke, heart attack, cancer, Cardiovascular disease, liver, kidney and thyroid disorders, Diabetes
No smoking
Do not take Oral Contraceptives
Intervention groups
After taking the drug for three months ,Menstrual patterns are examined and if they are regular Serum progesterone levels will be measured in the luteal phase
Main outcome variables
Measurements of serum progesterone in the luteal phase show more than 3 ng / ml The answer is to cure and prove ovulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210915052488N1
Registration date:2021-11-18, 1400/08/27
Registration timing:prospective
Last update:2021-11-18, 1400/08/27
Update count:0
Registration date
2021-11-18, 1400/08/27
Registrant information
Name
Saeed reza Simaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3844 2398
Email address
sreza.simaei@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of lavender versus metformin on polycystic ovary syndrome
Public title
Effect of lavender in treatment of polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of polycystic ovary syndrome by a gynecologist
Exclusion criteria:
Do not take drugs that lower blood pressure, blood fats and blood sugar
No pregnancy or breastfeeding
Do not take insulin sensitizers
Do not take aspirin or other anticoagulants
Do not take anti-prostaglandin drugs
Do not take other herbal medicines at the same time for your disease
No history of uncontrolled blood pressure, stroke, heart attack, cancer or heart attack, cardiovascular disease, liver, kidney and thyroid disorders, type 1 or 2 diabetes
No smoking
Do not take oral contraceptives
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in block method with 4 blocks. Random sequencing will be generated by the epidemiology and statistics consultant using the site https://www.sealedenvelope.com.
Randomization unit: individual
Hide: Only the consultant will be aware of the random sequence. In the mentioned site, it is possible to assign a code to each person. Therefore, the next person will not know what treatment he is going to receive (A or B) and only the person who performed the random sequence And will not be involved in assigning samples to groups and evaluating patients will be aware of the random sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this Clinical trial is double-blind. The participant and the data evaluator will not know the type of treatment assigned. The shape of the drugs and their box are quite similar and Neither the participant nor the evaluator will know about its content.
Placebo
Not used
Assignment
Parallel
Other design features
Fasting glucose and insulin levels, prolactin, serum basal progesterone and TSH and free testosterone are measured. For patients with a radiologist with a vaginal ultrasound, a polycystic ovary view must be confirmed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
No. 2, Central Building., Kermanshah University of Medical Sciences., Shahid Beheshti Street
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2021-08-10, 1400/05/19
Ethics committee reference number
IR.KUMS.REC.1400.327
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Check menstrual days
Timepoint
After three months of treatment in the luteal phase
Method of measurement
Day
Secondary outcomes
1
Description
Measurement of serum Progesterone in the luteal phase
Timepoint
After three months of treatment in the luteal phase
Method of measurement
Measurement of serum progesterone in the luteal phase more than 3 Nanogram / milliliter
Intervention groups
1
Description
Intervention group: The drug is in the form of 500 mg capsules(One hundred grams of lavender is boiled in one liter of water to reach 100 milliliter The solution is then passed through a strainer. The filtered solution is poured into a snail to reach a concentration of 100 to 10 gram of dry extract. Capsules are made using 250 mg of starch oxide and 250 milligram of lavender. Product standardization is based on the total phenolic content).It is prescribed twice a day for three months. Made by Engineer Kamalinejad in the laboratory of the Faculty of Pharmacy, hahid Beheshti University of Medical Sciences, Tehran.
Category
Treatment - Drugs
2
Description
Control group: This group is prescribed metformin 500 milligram tablets three times a day for three months.From the pills of Abidi Pharmaceutical Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Aria Hospital
Full name of responsible person
Mahboubeh Rostami
Street address
West Golestan Ave., Shahid Gamran Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176614848
Phone
+98 51 3222 9094
Email
dr.rostami.m70@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khoda Rahmi
Street address
Building No. 2, of Medical Sciences - Deputy of Research and Technology ., Shahid Beheshti Blvd Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 6835
Email
research_it@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Saeed Reza Simaei
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.20, 21, Adalat St., Ahmadabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176614849
Phone
+98 51 3847 0500
Email
sreza.simaei@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Saeedreza Simaei
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No 20, Adalat 21 Ave., Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176614850
Phone
+98 51 3844 2398
Email
sreza.simaei@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Saeedreza Simaei
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No .20, Adalat 21 Ave., Ahmadabad Blvd
City
kermanshah
Province
Kermanshah
Postal code
9176614850
Phone
+98 51 3844 2398
Email
sreza.simaei@kums.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
In this study scientific data Except for personal data of individuals will be shared.
When the data will become available and for how long
Scientific content will be available six months after the results are published
To whom data/document is available
Scientific data and documentation will be available to researchers
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Saeed Reza Simaei
sreza.simaei@kums.ac.ir
What processes are involved for a request to access data/document
After confirming the reference, the file will be sent to the applicant no later than one month later