The effect of herbal mixture extract on endometrial histology in patients with disordered proliferative endometrium and simple hyperplasia.
Design
80 women divided into equal groups who are matched for not having long term exposure to estrogen or progestron and don’t have female neoplastic disorders.
Patients are randomly divided into two groups A & B based on Randlist software.
Settings and conduct
After standardization of herbal mixture (Curcuma longa, Citrus sinensis, Vitex agnus-castus and, Melissa officinalis) final formulation according to Food and Drug Administration (FDA), by the Pharmaceuticals International Company, the Clinical Trial study will be carried out.Patients in the control group will receive Megestrol Acetate 40 mg daily for three months with placebo (500 mg) daily aAnd in the intervention group, patients will receive Megstrol acetate 40 mg daily with a combination of 500 mg of plant extract daily for three months.Then, in the two groups, endometrial histology will be studied.After 3 months, endometrial biopsy is performed and samples are investigated by two pathologists. The results are compared before and after treatment by a gynecologist.
Participants/Inclusion and exclusion criteria
All women over 18 years of age have abnormal uterine bleeding and proliferative endometrium with irregular glands
Intervention groups
Intervention group will consume Megestrol Acetate (40 mg)(made in Iran, Abooreyhan company) daily along with a medicinal herb mixture (500 mg) daily for three months
Patients in the control group will receive Megestrol Acetate (40 mg) daily with placebo(which is similar in shape, size and color to herbal medicine) (500 mg) daily for three months.
Main outcome variables
Pathological results are considered as the main outcome of this study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120922010901N9
Registration date:2022-01-16, 1400/10/26
Registration timing:registered_while_recruiting
Last update:2022-01-16, 1400/10/26
Update count:0
Registration date
2022-01-16, 1400/10/26
Registrant information
Name
Parvin Mostafa Gharebaghi
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
gharabagh.p@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2023-01-10, 1401/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of herbal mixture extract on endometrial histology in patients with disordered proliferative endometrium and simple hyperplasia.
Public title
The effect of herbal mixture extract on endometrial histology in patients with disordered simple hyperplasia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with abnormal uterine bleeding and proliferative endometrium with irregular glands
Willingness to participate in the study
Lack of sensitivity to the plants used in the study
Exclusion criteria:
Thromboembolism
Severe liver dysfunction
High blood pressure
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
First, we will do the randomization using the program (www.graphpad.com).
Then, the sealed envelope method will be used for concealment. In this way, each number will be written on a card and then placed inside the envelopes. We will glue the lids of the envelopes and put them in the boxes. for Participants in order of entering, one of the envelopes will be opened and the assigned group to that participant will be determined
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are then randomly divided into two groups (A and B). Patients in the control group will receive placebo with megestrol.
Then the pathology results without mentioning the type of treatment performed on the patient, with headings A and B will be provided to the analyst to evaluate the consequences.So, these people will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.TBZMED.REC.1400.856
Health conditions studied
1
Description of health condition studied
malignant neoplasm of female genital organs
ICD-10 code
C54.1
ICD-10 code description
malignant neoplasm of female genital organs
Primary outcomes
1
Description
Endometrial histology
Timepoint
Before intervention, three months after intervention
Method of measurement
Endometrial biopsy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group will consume Megestrol Acetate (40 mg) daily along with a medicinal herb mixture (500 mg) daily for three months
Category
Treatment - Drugs
2
Description
Control group:Patients in the control group will receive Megestrol Acetate (40 mg) daily with placebo(which is similar in shape, size and color to herbal medicine) (500 mg) daily for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr. Parvin Mostafa Gharabaghi
Street address
Alzahra Hospital, South Artesh St.,Tabriz, iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
Gharabagh.p@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Parvin Mostafa Gharabaghi
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parvin Mostafa Gharabaghi
Position
Gynecologist, fellow of Women's Oncology / Associate Professor Obstetrics Midwifer
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1553 9161
Email
gharabagh.p@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parvin Mostafa Gharabaghi
Position
Gynecologist, fellow of Women's Oncology / Associate Professor Obstetrics Midwifer
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1553 9161
Email
gharabagh.p@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parvin Mostafa Gharabaghi
Position
Gynecologist, fellow of Women's Oncology / Associate Professor Obstetrics Midwifer
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1553 9161
Email
gharabagh.p@tbzmed.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