Investigating the effect of EstroG-100 herbal extract on the improvement of hot flashes in postmenopausal women in two intervention and control groups.
Investigating the effect of EstroG-100 herbal extract on the improvement of hot flashes in postmenopausal women in two intervention and control groups.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 70 patients. The rand function of Excel software was used for randomization.
Settings and conduct
A study was conducted on 70 menopausal women who referred to the gynecology clinic of Ayatollah Taleghani and Imam Hossein (AS) hospitals with hot flashes. The people in the intervention group were given EstroG-100 capsules for 12 weeks, and the people in the control group were given a placebo drug. In order to blind the patients and the researcher, each patient was randomly assigned to the intervention or placebo group based on the rand function of the Excel software.
Participants/Inclusion and exclusion criteria
Study exclusion criteria include: concurrent use of nutritional supplements to manage menopause syndrome, any suspicion of breast and endometrial malignancies, history of using estrogen or progesterone products in the past three months, psychoactive drugs, BMI greater than 40, bleeding Irregular within 1 year after menopause, hysterectomy, uncontrolled blood pressure and ...
Intervention groups
People in the intervention group were given EstroG-100 capsules for 12 weeks and these people consumed 2 capsules every day. People in the control group were also given a placebo drug, which they also took 2 times a day for 12 weeks.
Main outcome variables
Age; marital status; menopause age; underlying disease; pregnancy history; Body Mass index; drug use; drug use; EstroG-100 drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220716055479N1
Registration date:2022-10-17, 1401/07/25
Registration timing:retrospective
Last update:2022-10-17, 1401/07/25
Update count:0
Registration date
2022-10-17, 1401/07/25
Registrant information
Name
Golnaz Fallah Talouki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4204 1146
Email address
golnaz.fallah.talouki@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-27, 1400/10/06
Expected recruitment end date
2022-03-26, 1401/01/06
Actual recruitment start date
2021-12-27, 1400/10/06
Actual recruitment end date
2022-03-26, 1401/01/06
Trial completion date
2022-04-04, 1401/01/15
Scientific title
Investigating the effect of EstroG-100 herbal extract on the improvement of hot flashes in postmenopausal women in two intervention and control groups.
Public title
Investigating the effect of EstroG-100 herbal extract on the improvement of hot flashes in postmenopausal women in two intervention and control groups.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Normal BMI
Absence of underlying disease
Exclusion criteria:
Unwillingness to participate in the study
Use of hormonal drugs containing estrogen and progesterone in the last three months
drug use
BMI greater than 40
irregular bleeding within 1 year after menopause
hysterectomy
uncontrolled blood pressure
thyroid diseases
diabetes mellitus
history of hormone related cancers
Age
No age limit
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Actual sample size reached:
70
More than 1 sample in each individual
Actual sample size in each individual:
35
One group received the main drug (35 patients, two pills a day for 3 months) and the control group (35 patients, two pills a day for 3 months) received a placebo.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and description of each method: simple randomization, block
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researchers
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of medical sciences
Street address
Shahid Beheshti University
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-12-21, 1400/09/30
Ethics committee reference number
IR.SBMU.MSP.REC.1400.644
Health conditions studied
1
Description of health condition studied
hot flash
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Investigating the hot flush symptoms based on the patients' answers (the criteria of a questionnaire designed with three states of mild, moderate and severe)
Timepoint
12weeks
Method of measurement
In the first visit, for those eligible to enter the study, they were asked to fill out the form related to severity (mild: sudden hot flush, moderate: sudden hot flush with severe sweating, severe: sudden hot flush with Sweating and interference with daily activities), the number of hot flashes (within a week), should be completed weekly from one week before the treatment to 12 weeks after the treatment and delivered at each visit.In case of not being able to visit these people in person, information will be collected on a weekly basis and during phone calls. Medicines were delivered to people in the clinic during three stages at the beginning of the treatment, the end of the 4th week and the end of the 8th week.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: recipient of ESTROG-100, which this plant extract contains a combination of three plant roots (Cynanchum wilfordii Hemsley plants (Catus family), Phlomis umbrosa Turczaninow (Vanaceae family) and Angelica gigas Nakai (Hycanthus hyacinth)) which is in capsule form by It is prepared by Behestan Daro Company in Iran and is provided to the patient. The patient should take 2 capsules daily for 90 days. In addition, the placebo also contains starch in the same packaging and the same color as the original drug. All the people participating in the study were divided into two main and placebo groups after being informed about the method of conducting the study and after completing the informed consent form. Trainings were provided to the participants regarding how to take the medicine, how to complete the questionnaire based on the severity of the hot flashes (mild, moderate and severe types) and weekly visits to receive the medicine.
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 to (non-identifiable individuals)
When the data will become available and for how long
Data access 6-8 months after the publication of the article
To whom data/document is available
researchers
Under which criteria data/document could be used
If the findings obtained in the plan lead to the improvement of women's health and the improvement of menopausal problems
From where data/document is obtainable
The main author
What processes are involved for a request to access data/document
If needed, the study data will be provided to the Shahid Beheshti University of Medical Sciences Research Office and the applicant will be able to access the information through the research office.