Protocol summary
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Study aim
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Comparison of effect of nettle, acupuncture and combined treatment with placebo in menopausal hot flashes
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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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1-Intervention group 1: Nettle in the form of an orthodine tablet with a dose of 150 mg three times a day and an acupuncture twice a week for 7 weeks.
2- Intervention group 2: Placebo of Nettle three times a day and acupuncture twice a week for 7 weeks.
3- Intervention 3: Nettle in the form of an orthodine pill with a dose of 150 mg every three times a day and an acupuncture twice a week for 7 weeks.
4-Placebo group: Placebo of Nettle three times a day and tampon acupuncture twice a week 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:
IRCT201707017265N10
Registration date:
2017-08-13, 1396/05/22
Registration timing:
registered_while_recruiting
Last update:
2018-10-25, 1397/08/03
Update count:
1
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Registration date
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2017-08-13, 1396/05/22
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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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Deputy of Research of Mashhad University of Medical Sciences
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Expected recruitment start date
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2017-08-11, 1396/05/20
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Expected recruitment end date
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2017-12-11, 1396/09/20
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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, acupuncture and their combined therapy on hot flashes during menopause
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Public title
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Treatment of menopause by Nettle and acupuncture
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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:
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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:
68
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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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2017-07-15, 1396/04/24
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Ethics committee reference number
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IR.MUMS.REC.1396.144
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 5 and 8
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Method of measurement
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Menopausal Quality of Life 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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Acupuncture, two sessions/week from week 1 to 4, and one session/week through weeks 5 to 7 + 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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Acupuncture, two sessions from week one to fourth and one session at week five through seventh + placebo nettle, once every three weeks for seven weeks.
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Category
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Other
3
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Description
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Acupuncture sham, two sessions from week one to fourth, and one session in the fifth to seventh week + nettle in the form of a 150 mg orthidine tablet every three times for seven weeks.
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Category
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Other
4
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Description
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Acupuncture sham, two sessions from week one to fourth and one session at week five to seven + placebo nettle three times a day for seven weeks
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Category
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Other
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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Vice chancellor for research, 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