Protocol summary
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Study aim
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Comparison of the Effect of Urticaria dioica with Placebo in hot flash of Postmenopausal Women.
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Design
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Randomized, double blinded, placebo controlled, community based pragmatic clinical trial with a parallel group
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Settings and conduct
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Chinese and Complementary Medicine clinic & Gynecology clinic, Imam Reza Hospital
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Number and severity of hot flashes; measurement of LH and FSH and estradiol MRS questionnaire
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110809007265N11
Registration date:
2018-05-23, 1397/03/02
Registration timing:
registered_while_recruiting
Last update:
2018-11-04, 1397/08/13
Update count:
1
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Registration date
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2018-05-23, 1397/03/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-05-18, 1397/02/28
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Expected recruitment end date
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2018-06-18, 1397/03/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effect of Urtica dioica with placebo in hot flashes during menopause.
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Public title
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Effect of Nettle in treatment of menopausal hot flash
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 45 years old to 60 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
42
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Sealed envelopes
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, researcher, questioner, and data analyzer will be blind in this study.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-05-07, 1397/02/17
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Ethics committee reference number
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IR.MUMS.REC.1396.335
Health conditions studied
1
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Description of health condition studied
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Menopause
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ICD-10 code
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N95.1
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ICD-10 code description
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Menopausal and female climacteric states
Primary outcomes
1
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Description
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Level of FSH, estradiol, LH
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Timepoint
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Before the study and at week 8
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Method of measurement
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blood test
2
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Description
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Severity of menopausal symptoms
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Timepoint
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Before the intervention, week 4 and 7
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Method of measurement
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Menopausal Rating Scale questionnaire
3
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Description
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Number and severity of hot flashes per day
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Timepoint
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One week before the study and at weeks 5 and 8
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Method of measurement
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Patient Daily Report
Intervention groups
1
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Description
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Intervention group: nettle in the form of Urtidin tablet 150 mg, 3 times/ day for 7 weeks.
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Category
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Treatment - Other
2
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Description
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Control group: nettle placebo tablet, three times a day for seven weeks
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available