This study aims to determine the effect of Humulus Lupulus on early menopause symptoms in menopausal and perimenopausal women. Design: Two parallel arm Randomized Controlled Trial. Setting and conduct: This study will be conducted in health centers of Tabriz city-Iran. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment. Eligible women will be randomly assigned into two groups of 60 subjects with block sizes of 4 and 6, stratified by menopausal status. Participants: 120 menopausal or perimenopausal married women aged 40 to 60 years old suffering from early menopause symptoms. Interventions: The intervention group will receive Humulus Lupulus tablet daily for 90 days and the control group will receive placebo tablet daily for 90 days. To ensure of taking of drugs, the researcher will contact with participants during 2, 6 and 10 weeks by phone. Main outcome measures: Early menopause symptoms and hot flushes number will be assessed by the Greene Scale and checklist respectively at baseline, 4, 8 and 12 weeks after starting the intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010110324N7
Registration date:2013-04-10, 1392/01/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-04-10, 1392/01/21
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Humulus Lupulus on early menopausal symptoms in menopausal and perimenopausal women: A Randomised Controlled Trial
Public title
Effect of Humulus Lupulus on early menopausal symptoms in menopausal and perimenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Married women aged 40 to 60 years; Willingness to participate in the study; Complaining of hot flashes; having literacy and being able to answer questions; having a Phone; having a score greater than 15 and less than 42 based on Greene scale.
Exclusion criteria: Taking drugs including sulfonamides, methotrexate, triamterene, sulfasalazine, estrogen, phenytoin, benzodiazepines, antidepressants, antithyroid, chemical drugs and multivitamin; hormone therapy and the use of OCP during the last 3 months, using vegetable alternative supplement for vasomotor symptoms during the past month; Contraindications of hormone therapy including suspected or known breast or endometrial cancer, undiagnosed abnormal vaginal bleeding, active thromboembolic disorders and active disease of liver or gallbladder; sensitive to lactose; use of medicines that cause hot flushes including breast cancer treatment drugs like letrozole, raloxifene, amlodipine, Bethanecol, hydrochloride, desmopressin and calcitonin.
Age
From 40 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Postal code
Approval date
2013-02-18, 1391/11/30
Ethics committee reference number
91209
Health conditions studied
1
Description of health condition studied
Menopause
ICD-10 code
N95.1, N95
ICD-10 code description
Menopausal and female climacteric states, Other specified menopausal and perimenopausal disorders
Primary outcomes
1
Description
Total and subdomains scores of early menopause symptoms in perimenopausal women
Timepoint
Before intervention, 4, 8 and 12 weeks after intervention
Method of measurement
Greene scale
2
Description
Total and subdomains scores of early menopause symptoms in postmenopausal women
Timepoint
Before intervention, 4, 8 and 12 weeks after intervention
Method of measurement
Greene scale
3
Description
Frequency of hot flashes in perimenopausal women
Timepoint
Before interventions, 4, 8 and 12 weeks after intervention
Method of measurement
Checklist for daily counts
4
Description
Frequency of hot flashes in postmenopausal women
Timepoint
Before intervention, 4, 8 and 12 weeks after intervention
Method of measurement
Checklist for daily counts
Secondary outcomes
1
Description
Comparison of the effect of Humulus Lupulus on early menopause symptoms and frequency of hot flushes in postmenopausal and perimenopausal women
Timepoint
4, 8 and 12 weeks after intervention
Method of measurement
Greene scale and Checklist for daily counts
Intervention groups
1
Description
The intervention group will receive 500 mg Humulus Lupulus tablet daily for 90 days. Glandular powder separated from the strobiles of the Humulus lupulus (hops) plant will be used for making tablets
Category
Treatment - Drugs
2
Description
The control group will receive 500 mg placebo tablet daily for 90 days. Placebo tablets contain lactose
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz health centers
Full name of responsible person
Aghamiri Vida
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Shakouri Seyyed Kazem
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Aghamiri Vida
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
East Azerbaijan
Postal code
66156-15733
Phone
+98 87 1222 8597
Fax
-
Email
aghamiri.vida@gmail.com; vida_bist@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mozhgan Mirghafourvand
Position
PhD of reproductive health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
347-51745
Phone
+98 41 1479 6770
Fax
-
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)