Comparison of the Effect of Urticaria dioica with Placebo in hot flash of Postmenopausal Women.
Design
Randomized, double blinded, placebo controlled, community based pragmatic clinical trial with a parallel group
Settings and conduct
Chinese and Complementary Medicine clinic & Gynecology clinic, Imam Reza Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Post-menopausal women (defined as: amenorrhea for 12 months or more) who suffer from hot flashes; Age 45-60 years old; Approval for treatment of hot flashes; Consent to participate in the study.
Exclusion Criteria: History of hysterectomy or oophorectomy; Anticancer therapies due to malignancy; History of estrogen-dependent cancers over the past five years; History of allergy to urticaria; History of known psychiatric disorders; Hyperthyroidism or hypothyroidism; ;Cardiovascular disease (coronary artery disease, cerebrovascular disease and thromboembolic disorders); Uncontrolled Hypertension; Uncontrolled diabetes; Kidney or liver failure; Use of anticoagulants; Taking any medication for hot flashes such as HRT and SSRI in the past eight weeks; Endometrial thickness over 12 mm in uterine ultrasonography; Vaginal bleeding with unknown origin in the past 6 months
Intervention groups
Intervention group: Urticaria dioica in the form of Urtidin tablet 150 mg, 3 times/ day for 7 weeks.
Control group: placebo tablets three times a day for 7 weeks.
Main outcome variables
Number and severity of hot flashes; measurement of LH and FSH and estradiol MRS questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110809007265N11
Registration date:2018-05-23, 1397/03/02
Registration timing:registered_while_recruiting
Last update:2018-05-23, 1397/03/02
Update count:1
Registration date
2018-05-23, 1397/03/02
Registrant information
Name
Hoda Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
azizih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-18, 1397/02/28
Expected recruitment end date
2018-06-18, 1397/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Urtica dioica with placebo in hot flashes during menopause.
Public title
Effect of Nettle in treatment of menopausal hot flash
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Post-menopausal women (defined as: amenorrhea for 12 months or more) who suffer from hot flashes.
Age 45-60 years old
Approval for treatment of hot flashes and consent to participate in the plan.
Exclusion criteria:
History of hysterectomy or oophorectomy
Anticancer therapies due to malignancy
History of estrogen-dependent cancers over the past five years
History of allergy to urticaria
History of known psychiatric disorders
Hyperthyroidism or hypothyroidism
Conditions and physical illnesses that are not suitable for this study: Cardiovascular disease (coronary artery disease, cerebrovascular disease and thromboembolic disorders) uncontrolled Hypertension or diabetes, kidney or liver failure
use of anticoagulants
Taking any medication for hot flashes such as HRT and SSRI in the past eight weeks
Endometrial thickness over 12 mm in uterine ultrasonography
Vaginal bleeding with unknown origin in the past 6 months
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, researcher, questioner, and data analyzer will be blind in this study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Approval date
2018-05-07, 1397/02/17
Ethics committee reference number
IR.MUMS.REC.1396.335
Health conditions studied
1
Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Level of FSH, estradiol, LH
Timepoint
Before the study and at week 7
Method of measurement
blood test
2
Description
Severity of menopausal symptoms
Timepoint
Before the intervention, week 4 and 7
Method of measurement
Menopausal Rating Scale questionnaire
3
Description
Number and severity of hot flashes per day
Timepoint
One week before the study and at weeks 4 and 7
Method of measurement
Patient Daily Report
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: nettle in the form of Urtidin tablet 150 mg, 3 times/ day for 7 weeks.
Category
Treatment - Other
2
Description
Control group: nettle placebo tablet, three times a day for seven weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Chinese and Complementary clinic of Imam Reza Hospital
Full name of responsible person
Dr. Hoda Azizi
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2035
Email
azizih@mums.ac.ir
2
Recruitment center
Name of recruitment center
Gynecology Clinic of Imam Reza Hospital
Full name of responsible person
Dr. Seyyedeh Azam Pourhoseini
Street address
Imam Reza Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Pourhoseinia@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
دکتر محسن تفقدی
Street address
Deputy of research office, MUMS central office, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Phone
+98 51 3459 1357
Email
tafaghodim@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
Dr Hoda Azizi
Position
Clinical Ph.D./Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Acupuncturist
Street address
Department of Chinese and complementary medicine, School of traditional and complementary medicine, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9279
Email
azizih@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hoda Azizi
Position
Clinical Ph.D./Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Acupuncture
Street address
Department of Chinese and complementary medicine, School of traditional and complementary medicine, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9279
Email
azizih@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Raheleh Kargozar
Position
PhD student of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Iranian Medicine
Street address
School of Iranian and Complementary Medicine, University campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9279
Email
kargozarr931@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