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A comparative study on the effects of Hypericum Perforatum and passion flower on the menopausal symptoms of women referring to Isfahan city health care centers

Protocol summary

Summary
Objectives : The aim of this research was to pinpoint and compare the effects of Hypericum Perforatum and Passion Flower on menopausal symptoms. Design : The present study was a three-phase, two group quasi-experimental clinical trial conducted in 1388 in Isfahan City Treating and Hygienic Centers. Setting and conduct :59 menopausal women After giving complete explanations to the qualified women about the stages and the kind of research and taking written consent, the Personal Fertility Features Questionnaire and the Cooperman's index were filled out and individuals were randomly assigned into two groups. Randomization was done by using the random number table, so that the odd numbers were assigned to Hypericum Perforatum Group and the even numbers to Passion Flower Group. Afterwards, throughout the third and sixthweeks of intervention, the Cooperman's index was filled out again. Participants including major eligibility criteria : the women who had not experienced menopause in the last year؛ women who were at first 5-year period of menopause؛ those who had the score of 15 from Cooperman's index for menopausal symptoms. Exclude criteria: Those women who were suffering؛ whatsoever؛ from severe gastrointestinal problems or were not able to take the medications or had side effects following using the two medications of the study were omitted. Intervention :The procedure for taking the medications was like this: Hypericum Perforatum, 160 mg effervescent table, three times a day, PassionFlower, 30 mg, 20% Pass P drop , 20 drops in morning , and 40 drops before sleeping. Afterwards, throughout the third and sixthweeks of intervention, the Cooperman's index was filled out again. Main outcome measures (variables): The Cooperman's index consists of eleven symptoms of menopause (heatstroke, insomnia, fatigue, depression, palpitation, headache, muscular and joint-relatedpains, anger, vertigo.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013031712835N1
Registration date: 2013-05-25, 1392/03/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-05-25, 1392/03/04
Registrant information
Name
Zahra Asali
Name of organization / entity
Toyserkan Azad university
Country
Iran (Islamic Republic of)
Phone
+98 81 1825 1223
Email address
z.asali@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Science, ُSchool of Nursing and Midwifery, Maryam Kian pour, Adress: Isfahan University of Medical Science, Vice chancellor for research, Hezar jirib Street, Isfahan
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2009-10-07, 1388/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effects of Hypericum Perforatum and passion flower on the menopausal symptoms of women referring to Isfahan city health care centers
Public title
effect of st jhon's wort and passion flower on monopausal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
include criteria ؛the women who had not experienced menopause in the last year؛ women who were at first 5-year period of menopause؛ those who had the score of 15 from Cooperman's index for menopausal symptoms؛ women who did not have any known psychological disturbances and did not have any record for these problems؛ women who didn't suffer from thyroid diseases؛ psychosomatic disorders؛ pheochromocytoma؛ carcinoid syndrome؛ leukemiacancer and any known systemic diseases such as blood pressure, diabetes, cardiovascular problems؛ those who did not take hormonal treatments؛ nutritional supplements؛ herbal drugs؛ homeopathy for soothing their menopausal symptoms and did not take medications that could have intervention with Hypericum Perforatum and Passion Flower and finally؛ did not have a BMI more than 30 kg/m2 and precocious menopause (before the age of 40 years). exclude criteria : Those women who were suffering whatsoever, from severe gastrointestinal problems ؛ were not able to take the medications or had side effects following using the two medications of the study were omitted.
Age
From 40 years old to 58 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 59
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan university Medical Science
Street address
Isfahan university medical Science , HezarJirib Street, Isfahan
City
Isfahan
Postal code
Approval date
2009-06-22, 1388/04/01
Ethics committee reference number
388102

Health conditions studied

1

Description of health condition studied
Menopause Symptoms
ICD-10 code
n95
ICD-10 code description
Menopausal and other perimenopausal disorders

Primary outcomes

1

Description
cooperman's Hot flash : not , Mild, Moderate , Sever
Timepoint
pre-intervention, the third week of intervention, and the sixthweek of intervention.
Method of measurement
Questionnaire cooperman's index

2

Description
cooperman's Depression: not , Mild, Moderate , Sever
Timepoint
pre-intervention, the third week of intervention, and the sixthweek of intervention.
Method of measurement
Questionnaire cooperman's index

3

Description
cooperman's Insomnia: not , Mild, Moderate , Sever
Timepoint
pre-intervention, the third week of intervention, and the sixthweek of intervention.
Method of measurement
Questionnaire cooperman's index

4

Description
cooperman's Anxiety: not , Mild, Moderate , Sever
Timepoint
pre-intervention, the third week of intervention, and the sixthweek of intervention.
Method of measurement
Questionnaire cooperman's index

5

Description
cooperman's Headache: not , Mild, Moderate , Sever
Timepoint
pre-intervention, the third week of intervention, and the sixthweek of intervention.
Method of measurement
Questionnaire cooperman's index

6

Description
cooperman's Palpation: not , Mild, Moderate , Sever
Timepoint
pre-intervention, the third week of intervention, and the sixthweek of intervention.
Method of measurement
Questionnaire cooperman's index

Secondary outcomes

1

Description
Vaginal dryness
Timepoint
6weeks after intervention
Method of measurement
Yes, No

Intervention groups

1

Description
Intervention group 1: st john's wort group : tab 160 mg, 3 times a day, for 6 weeks
Category
Treatment - Drugs

2

Description
Intervention group 2 : passion flower drop : 20drops in mornings, 40 drops at night for 6 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan City Treating and Hygienic Centers: Navab safavi
Full name of responsible person
Zahra Asali
Street address
Isfahan university medical Science , HezarJirib Street, Isfahan
City
Isfahan

2

Recruitment center
Name of recruitment center
Isfahan City Treating and Hygienic Centers: Ebnesina
Full name of responsible person
Zahra Asali
Street address
Isfahan university medical science, Hezar jirib Street, Isfahan
City
Isfahan

3

Recruitment center
Name of recruitment center
Isfahan City Treating and Hygienic Centers: Motahari
Full name of responsible person
Zahra Asali
Street address
Isfahan university medical science, Hezar jirib Street, Isfahan
City
Isfahan

4

Recruitment center
Name of recruitment center
Isfahan City Treating and Hygienic Centers: Zeynabiyeh
Full name of responsible person
Zahra Asali
Street address
Isfahan university medical science, Hezar jirib Street, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Isfahan University of Medical Science, School of Nursing and Midwifer
Full name of responsible person
Maryam Kian pour , phon number 00983116680048
Street address
Isfahan university medical Scinece, Hezar jirib Street,Vice chancellor for research Isfahan
City
Isfahan
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,Isfahan University of Medical Science, School of Nursing and Midwifer
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
Isfahan university medical science
Full name of responsible person
Isfahan university medical science
Position
Vice chancellor for research
Other areas of specialty/work
Street address
Isfahan university medical science, Hezar jirib street,Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 0048
Fax
Email
mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Zahra Asali
Position
Master s of Midwifery
Other areas of specialty/work
Street address
Isfahan University of Medical Science, Hezar jirib street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 0048
Fax
Email
Z.asali@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Zahra َAsali
Position
MSc, School of Nursing and Midwifery ,Toyserkan azad university
Other areas of specialty/work
Street address
Isfahan University of Medical Science, Hezar jirib Street ,Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 0048
Fax
Email
z.asali@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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