The effectiveness of a Rheum officinale on hot flashes in menopausal women compared to placebo.
Design
Clinical trials with control group, with parallel groups, blind, randomized
Settings and conduct
The study is a double-blind clinical trial in Tehran's health care centers. Among 90 menopausal women with hot flashes based on the inclusion criteria, they were selected and received consent after entering the study,The personal and medical information questionnaire is completed for each patient and they are asked to complete and deliver a questionnaire on the severity of hot flash before treatment,The drug packets that are numbered randomly in a double blind form are given to the patients and randomly divided into two groups of rheum and placebo, then received a drug or placebo. The method of use is explained, women in the first group receive 500 mg of rheum twice a day for 8 weeks ,the second group of 500 mg of placebo twice a day for 8 weeks .After 8 weeks of treatment, the hot flashes questionnaire will be completed again by them
Participants/Inclusion and exclusion criteria
Inclusion criteria:
En Women who have not experienced menstruation in last 12 months
The complainant of hot flashes
Lack of medical illness or medication during the study
No addiction or smoking
Have at least reading and writing literacy
Possibility of patient tracking
consent to enter the study
Exclusion criteria:
Use of chemical medicine to treat hot flashes
Use a herbal medicine or a special diet to treat hot flashes
The disease is known during the study
There is a history of allergy to the drug or herbal compounds
History of intestinal surgery
Intervention groups
Therapeutic intervention:500 mg of rheum twice a day for 8 weeks
Placebo intervention: 500 mg of placebo twice a day for 8 weeks
Main outcome variables
decrease of the severity, frequency and duration of hot flashes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181015041345N1
Registration date:2019-05-06, 1398/02/16
Registration timing:prospective
Last update:2019-05-06, 1398/02/16
Update count:0
Registration date
2019-05-06, 1398/02/16
Registrant information
Name
najmeh bagheriani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5558 0388
Email address
bagheriani.n@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of a Rheum officinale on Hot Flashes in Menopausal women compared with placebo.
Public title
The effectiveness of a Rheum officinale on Hot Flashes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women who have not experienced menstruation in last 12 months
The complainant of hot flashes
Lack of medical illness or medication during the study
No addiction or smoking
Have at least reading and writing literacy
Possibility of patient tracking
consent to enter the study
Exclusion criteria:
Use of chemical medicine to treat hot flashes
Use a herbal medicine or a special diet to treat hot flashes
The disease is known during the study
There is a history of allergy to the drug or herbal compounds
History of intestinal surgery
Age
From 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done by Randomizer software, before starting the trial. Patients who have inclusion criteria, are randomly assigned into one of the two groups: Drug or placebo capsul.
Blinding (investigator's opinion)
Double blinded
Blinding description
Absence of knowledge of the participants and the clinical care observant and principal researcher of the drug or placebo capsul
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commitee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences,next to Milad Tower, Hemmat Highway
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.IUMS.REC.1397.1286
Health conditions studied
1
Description of health condition studied
flushing
ICD-10 code
R23.2
ICD-10 code description
Flushing
Primary outcomes
1
Description
flushing questionnaire score
Timepoint
immediately before initiation of intervention, one month and two months after intervention
Method of measurement
questionnaire score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 500 mg of rheum twice a day for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: 500 mg of pharmaceutical starch twice a day for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers In Tehran Province
Full name of responsible person
Najmeh Bagheriani
Street address
No.847, Beginning of behesht Street, South Park City, Vahdat Islamic Street, Hassan Abad Square
City
tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5515 2191
Fax
+98 21 5561 3191
Email
bagheriani.n@tak.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Najmeh Bagheriani
Street address
Iran University of Medical Sciences,next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Najmeh Bagheriani
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.847, Beginning of behesht Street, South Park City, Vahdat Islamic Street, Hassan Abad Square
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5515 2191
Email
bagheriani.n@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Najmeh Bagheriani
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.847, Beginning of behesht Street, South Park City, Vahdat Islamic Street, Hassan Abad Square
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5515 2191
Email
bagheriani.n@tak.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Najmeh Bagheriani
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.847, Beginning of behesht Street, South Park City, Vahdat Islamic Street, Hassan Abad Square
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5515 2191
Email
bagheriani.n@tak.iums.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