The aim of this proposal is to study the effect of different doses of piascledine on hot flashing of menopausal women in Jahrom city. sampling is easy with random assignment to experimental and control groups. women with menopausal according to kuperman index will be participated in the study.control group do not getting placebo.Inclusion criteria: menopausal women that have not menstural cycle among last one year; having hotflashes according to kuperman index; do not take another treatment such as hormone replacement, food supplements and plantal drugs.
Exclusion criteria: women can not continue using drug beacuse of gastrointestinal complication or other things.
The total sample size is 69. 23 patients in case group and 23 patients in control group (there are 2 control groups).
case group (1) will take one piascledine 300mg once a day, case group (2) will take 2 piascledine 300mg once a day and group 3 is control and will not take anything. the duration of taking drug is 3 months. finally the changes of hotflashing will be study according to kuperman index.
the study is three blind (patients in study, analysers and comittee).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051821653N3
Registration date:2015-06-15, 1394/03/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-15, 1394/03/25
Registrant information
Name
Athar Rasekh Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5432 6602
Email address
a.rasekh@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jahrom University of Medical Science
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of different doses of piascledine on hot flashing of menopausal women in Jahrom city.
Public title
Evaluation of treatment in menopausal wemon with hotflashes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: menopausal women that have not menstural cycle among last one year; having hotflashes according to kuperman index; do not take another treatment such as hormone replacement, food supplements and plantal drugs.
Exclusion criteria: nonmenopausal women; do not have hotflashing according to kuperman index; taking hormone replacement therapy; women can not continue using drug beacuse of gastrointestinal complication or other things.
Age
No age limit
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
69
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jahrom University of Medical Science
Street address
Motahhari street, Jahrom, Fars
City
Jahrom
Postal code
Approval date
2015-02-25, 1393/12/06
Ethics committee reference number
Jums.REC.1393.121
Health conditions studied
1
Description of health condition studied
menopausal
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
Hotflashes
Timepoint
Before intervention and in first, second and third month after intervention
Method of measurement
Scoring is from 0 to 3 according to: not at all (0), a little (1), quite a bit (2), Extremely (3). then the hotflashes score will multiply to 4.
2
Description
Paraesthesia
Timepoint
Before intervention and in first, second and third month after intervention
Method of measurement
Scoring is from 0 to 3 according to: not at all (0), a little (1), quite a bit (2), Extremely (3). then the paraesthesia score will multiply to 2.
3
Description
Iinsomnia
Timepoint
Before intervention and in first, second and third month after intervention
Method of measurement
Scoring is from 0 to 3 according to: not at all (0), a little (1), quite a bit (2), Extremely (3). then the insomnia score will multiply to 2.
4
Description
Nervousness
Timepoint
Before intervention and in first, second and third month after intervention
Method of measurement
Scoring is from 0 to 3 according to: not at all (0), a little (1), quite a bit (2), Extremely (3). then the nervousness score will multiply to 2.
5
Description
Melancholia
Timepoint
Before intervention and in first, second and third month after intervention
Method of measurement
Scoring is from 0 to 3 according to: not at all (0), a little (1), quite a bit (2), Extremely (3). then the melancholia score will multiply to 1.
6
Description
Vertigo
Timepoint
Before intervention and in first, second and third month after intervention
Method of measurement
Scoring is from 0 to 3 according to: not at all (0), a little (1), quite a bit (2), Extremely (3). then the vertigo score will multiply to 1.
7
Description
Weakness
Timepoint
Before intervention and in first, second and third month after intervention
Method of measurement
Scoring is from 0 to 3 according to: not at all (0), a little (1), quite a bit (2), Extremely (3). then the weakness score will multiply to 1
8
Description
Arthralgia or myalgia
Timepoint
Before intervention and in first, second and third month after intervention
Method of measurement
Scoring is from 0 to 3 according to: not at all (0), a little (1), quite a bit (2), Extremely (3). then the arthralgia or myalgia score will multiply to 1.
9
Description
Headache
Timepoint
Before intervention and in first, second and third month after intervention
Method of measurement
Scoring is from 0 to 3 according to: not at all (0), a little (1), quite a bit (2), Extremely (3). then the headache score will multiply to 1.
10
Description
Palpitations
Timepoint
Before intervention and in first, second and third month after intervention
Method of measurement
Scoring is from 0 to 3 according to: not at all (0), a little (1), quite a bit (2), Extremely (3). then the palpitations score will multiply to 1.
11
Description
Formication
Timepoint
Before intervention and in first, second and third month after intervention
Method of measurement
Scoring is from 0 to 3 according to: not at all (0), a little (1), quite a bit (2), Extremely (3). then the formication score will multiply to 1.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: no intervention will take on them and do not take piascledine.
Category
Treatment - Drugs
2
Description
Case group (number1): will take one piascledine 300 mg pill daily, during three months.
piascledine should be used with food and a glass of water.
Category
Treatment - Drugs
3
Description
Case group (number2): will take two piascledine 300 mg pill daily, during three months. piascledine should be used with food and a glass of water.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor Athar Rasekh Jahromi`s clinic
Full name of responsible person
Athar Rasekh Jahromi
Street address
Farmandari Street, Jahrom, Fars
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Abas Rahmnian
Street address
Motahari Street, Jahrom, Fars
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Doctor Athar Rasekh Jahromi
Position
Obstetricians
Other areas of specialty/work
Street address
Motahari Street, Jahrom, Fars
City
Jahrom
Postal code
Phone
+98 715426602
Fax
Email
drrasekh@yahoo.comm.zareian91@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahram University of Medical Sciences
Full name of responsible person
Doctor Athar Rasekh Jahromi
Position
Obstetricians
Other areas of specialty/work
Street address
Motahari Street, Jahrom, Fars
City
Jahrom
Postal code
Phone
+98 715426602
Fax
Email
drrasekh@yahoo.comm.zareian912yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)