Comparative study of the effects of Melissa officinalis and Foeniculum vulgare extract with Nigella sativa capsule, with placebo for reduction of hot flushing in postmenopausal women
The aim of this study was to reduce flushing in women with menopause. In this double blind study, 46 postmenopausal women referring to health centers in Golestan province are examined. The criteria for inclusion in the study included consent for participation in the study, the sensitivity of the studied plants, postmenopausal women with a range The age range is 45-60. Exclusion criteria includes increased symptoms of hot flashes, the emergence of any mental illness. Randomly, one of the two groups receiving the 20 mg Citalopram tablet and black powdered capsule extract and Melissa leaf extract and fennel fruits (in the case of normal clinical trials), one gram daily after breakfast, and another group of 20 mg Citalopram tablets The placebo is consumed daily for eight weeks, divided into two months of the prescribed medications. The reduction in flushing in the post-treatment phase is compared to the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072622490N2
Registration date:2017-07-09, 1396/04/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-09, 1396/04/18
Registrant information
Name
Shohreh Vosoogh
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3225 1910
Email address
dr.vosoogh@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Islamic Azad University, Pharmaceutical Sciences Branch
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effects of Melissa officinalis and Foeniculum vulgare extract with Nigella sativa capsule, with placebo for reduction of hot flushing in postmenopausal women
Public title
Comparison of herbal drug with placebo in reducing hot flashes in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
Consent for participation in the study,lack of sensitivity to the studied plants, postmenopausal women with age of 45-60
exclusion criteria:
Sensitivity to the studied plants,increased symptoms of hot flushing, lack of Melissa officinalis and Foeniculum vulgare extract with Nigella sativa capsules and citalopram for more than 7 days during one month
Age
From 45 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
46
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 Islamic Azad University, Pharmaceutical Sciences Branch
Street address
No 99, Yasaman Street, Shariati Street
City
Tehran
Postal code
Approval date
2015-06-13, 1394/03/23
Ethics committee reference number
IR.IAU.PS.REC.1394.10
Health conditions studied
1
Description of health condition studied
Flushing
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Reducing the amount of sweating
Timepoint
Before the study,1 month,2 month
Method of measurement
Ask the patient
Secondary outcomes
empty
Intervention groups
1
Description
Therapeutic intervention with medication (capsules containing Melissa officinalis and Foeniculum vulgare extract with Nigella sativa powder) with dose of 1 gram and citalopram 20 mg tablet for two months
Category
Treatment - Drugs
2
Description
Placebo intervention, pharmaceutical starch with dose of one gram and citalopram 20 mg tablets
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers In Golestan Province
Full name of responsible person
shohreh vosoogh
Street address
City
gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Islamic Azad University, Pharmaceutical Sciences Branch
Full name of responsible person
Sepideh Arbabi Bid Goli
Street address
No99, Yasaman Street, Shariati Street
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 of Islamic Azad University, Pharmaceutical Sciences Branch
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
Islamic Azad University, Pharmaceutical Sciences Branch
Full name of responsible person
Aram Mousavi
Position
Doctor of pharmacy
Other areas of specialty/work
Street address
#99, Yasaman Street, Shariati Stree
City
Tehran
Postal code
00982188350573
Phone
+98 21 8835 0573
Fax
Email
afshar.shiima@gmail.comarammousavi70@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
shohreh vosoogh
Position
fellowship perinatology
Other areas of specialty/work
Street address
Sayad Shirazi Street, Sayad Shirazi Hospital
City
Gorgan
Postal code
00981732261175
Phone
+98 912 401 9434
Fax
+98 32261175
Email
dr.vosoogh@goums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Aram Mousavi
Position
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
0098
Fax
Email
afshar.shiima@gmail.comarammousavi70@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)