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The Effect of Hypericum perforatum on early menopausal symptoms

Protocol summary

Summary
The present study aims to analyze the effect of Hypericum performatum or as is called perforate on early complications of menopause. The study is a double blind clinical trial conducted on 80 women from Izeh city. The simple purposive sampling is used .( medicine and placebo groups). The subjects received Perforan tablet containing 330 micro grams Hypericin or placebo three time a day for 2 months. Data were collected using interview, personal characteristic questionnaire and Kupperman index symptom questionnaire in two rounds before treatment and 4 times after treatment. The study’s criteria include age between 45 and 60, amenorrhoea for at least 12 months, having at least two of menopause symptoms based on Kupperman index, and the ability to read and write. Women over the age 30 with unnatural menopause or hysterectomy amenorrhoea, oophorectomy, and radiation therapy due to systematic disease were excluded from the study. Hypericum performatum is the independent variable while the dependent variables include: hot flush, night sweats, insomnia, anger, depression, tiredness, headache, frequent urination, and pain in the bladder. Moreover, the intervening variables include age, education, marital status, length of time spent from amenorrhea, and body mass index.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016040820053N2
Registration date: 2016-09-19, 1395/06/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-19, 1395/06/29
Registrant information
Name
Narges Majidipour
Name of organization / entity
Dezful University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4228 7439
Email address
majidipour.n@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences Jundishapur Ahvaz, Vice Chancellor Of Research
Expected recruitment start date
2009-06-15, 1388/03/25
Expected recruitment end date
2010-11-15, 1389/08/24
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The Effect of Hypericum perforatum on early menopausal symptoms
Public title
The Effect of Hypericum perforatum on early menopausal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Age45-60 years, amenorrhea for at least 12 months, at least two symptoms of menopause, according to Kupperman index, patients could read and write; abnormal menopause induced ex. hysterectomy, oophorectomy or radiation therapy for known systemic disease such as endocrine disorders (thyrotoxicosis), dietary intake of phyto estrogen and specific regimes , having physical and mental diseases, sexual hormones consumption , sensitivity to herbal drugs, athletes women, antidepressants consumption, herbal medicines consumption, body mass index higher than 30 were excluded.
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: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Ahvaz Jondishapour University of Medical Sciences
Street address
Golestan Bolvar
City
Ahvaz
Postal code
6135715794
Approval date
2009-10-01, 1388/07/09
Ethics committee reference number
U-88221

Health conditions studied

1

Description of health condition studied
menopausal symptoms
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states

Primary outcomes

1

Description
Hot flushes
Timepoint
Before the study and weeks 2, 4, 6 and 8
Method of measurement
Kupperman’s index

2

Description
Depression
Timepoint
Before the study and weeks 2, 4, 6 and 8
Method of measurement
Kupperman’s index

Secondary outcomes

empty

Intervention groups

1

Description
For 2 months Perforan pills contain 330 µg hypericum tree times a day
Category
Treatment - Drugs

2

Description
For 2 months Placebo pills 3 times a day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of Medical Sciences , Vice Chancellor Of Research
Full name of responsible person
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jundishapur Ahvaz University of Medical Sciences, Vice Chancellor Of Research
Full name of responsible person
Shahnaz najar
Street address
Golestan Blvd.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapur Ahvaz University of Medical Sciences, Vice Chancellor Of Research
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
Ahvaz Jondishapour university of medical sciences
Full name of responsible person
Alieh Etemadi Kermani
Position
Master of Midwifery
Other areas of specialty/work
Street address
Golestan bolvar
City
Ahvaz
Postal code
6135715794
Phone
+98 61 4362 0065
Fax
Email
alieh_a@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Shanaz Najar
Position
Masters
Other areas of specialty/work
Street address
Golestan Bolvar
City
Ahvaz
Postal code
6135715794
Phone
+98 61 4362 0065
Fax
Email
najarshanaz@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences Ahvaz
Full name of responsible person
Mohammadreza Abbaspour
Position
Phd
Other areas of specialty/work
Street address
Golestan Bolvar
City
Ahvaz
Postal code
6135715794
Phone
+98 61 4362 0065
Fax
Email
abbaspourmr@ajums.ac.ir
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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