Objectives: The aim of this double-blind Randomized Controlled Trial study is the effects of cornus mas fruit on menopausal symptoms. Inclusion and exclusion criteria: menopause women with at least one year after amenorrhea history; that suffer of menopausal symptoms. They shouldn't: have history of malignancies, have active hepatic or renal disease, take HRT or other menopausal treatments, take progesterone and consumption of cornus mas. Study population and sample size: 84 menopause women referred to Rassol Akram hospital in Tehran. Intervention: In ten days before the intervention, we will complete a Kuperman Index questionnaire and another questionnaire included demographic characteristics, gynecological history, frequency and duration of hot flashing. Also the blood samples are taken for hormone measurements. Samples will be divided randomly in two groups; intervention group will take 3 capsules containing 500 mg cornus mas and the placebo control group will take capsules containing 500 mg starch both for 10 days and the process will repeated for third, fourth and fifth days study. These two capsules will be coded, and pot in to similar boxes with using order inside them, then one of our coworkers who don't know about coding process will give capsules to samples. The number of hot flashes and Kuperman index will be completed again for both groups. Two groups will be compared and results will be analyzed by SPSS software. Primary outcomes: treatment of menopausal symptoms. Before the study, we will explain our study to participations, if they be agree and sign the letter of satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012070210166N1
Registration date:2012-07-13, 1391/04/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-13, 1391/04/23
Registrant information
Name
Shahnaz Rimaz
Name of organization / entity
School of Public Health Iran University of Medical Sciences (TUMS)
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 9918
Email address
srimaz2000@yahoo.com
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Cornus mas fruit on menopausal symptoms in menopausal women
Public title
Effect of Cornus mas fruit on menopausal symptoms in menopausal women refers to the Clinics of Rasool Akram Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for intervention: Age 60-45 years; Amenorrhea for at least 12 months; Having at least 3 times in hot flushing medium during 24 hours and at least 2 weeks before study; Lack of history of allergy to Cornus mas use and its products; Not receiving hormone replacement therapy within 6 months; At present not use of estrogen and Medroxyprogestrone; Lack of effective drugs on hot flashes, such as clonidine, methyldopa, , veralpereid, naloxone and Tibolone; Lack of vaginal bleeding of unknown origin; Have not active liver disease and renal failure; No history of malignancy; No history of thromboembolism; Willingness to participate in the study.
Exclusion criteria of intervention: Vegetarian diet; Soya consumption; Cornus mas consumption; Regular use of vitamin; Smoking; take antibiotics ; Unwillingness to continue Cornus mas consumption.
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences,Tehran, Hemmat Highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-02-07, 1393/11/18
Ethics committee reference number
93-03-27-24790
Health conditions studied
1
Description of health condition studied
menopausal symptoms
ICD-10 code
099-094
ICD-10 code description
Other obstetric conditions, not elsewhere classified
Primary outcomes
1
Description
Menopausal symptoms, some inflammatory and bone markers, body fat percent
Timepoint
Ten days before the intervention- Beginning of the second ten days of study- For ten days in the third and fourth and fifth of the study
The intervention group will receive daily 3 capsules containing 500 mg of powdered Cornus mas for 4 weeks. Placebo group will receive daily 3 capsules containing 500 mg starch powder for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Rassol Akram hospital
Full name of responsible person
Shahla Chaichian
Street address
Rassol Akram hospital, Niaesh St, Sattar Khan St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr. Mousavi
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Shahnaz Rimaz
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Iran University of Medical Sciences (IUMS) , Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8860 4645
Fax
+98 21 8860 4645
Email
sh-rimaz@iums.ac.ir; srimaz2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahnaz Rimaz
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Iran University of Medical Sciences (IUMS) , Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8860 4645
Fax
+98 21 8860 4645
Email
sh-rimaz@iums.ac.ir; srimaz2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahnaz Rimaz
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Iran University of Medical Sciences (IUMS) , Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8860 4645
Fax
+98 21 8860 4645
Email
sh-rimaz@iums.ac.ir; srimaz2000@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)