1. Home
  2. Approved trials
  3. » فارسی

The effect of Hypericum on menopause early symptom

Protocol summary

Summary
(1) objective: The effect of Hypericum on menopause early symptom.(2) design: This study is a randomized clinical trial, double-blind, placebo-controlled that will be conducted using random sampling.(3) Setting and conduct:researcher will be selected 80 person after interviews and put them in intervention and control groups from among postmenopausal women referred to health centers the . On the first meet will be completed the demographic information and Kupperman Index questionnaire for samples.Intervention and control groups meet every second week for 8 weeks and to be completed and evaluated Kupperman Index questionnaire for them. Participants main of Inclusion and exclusion criteria: main inclusion criteria: age 60-45 years; amenorrhea for at least 12 months, ther are at least two menopause of symptom, according to Kupperman index.main exclusion criteria: Higher body mass index of 30; abnormal menopause, known systemic diseases, sexual hormones.(5) Interventions: to each of the women in the intervention group will be given perforan tablets (330 mg) three times a day and will be given a placebo control group.(6) The main outcome variables: hot flashes, night sweats, insomnia, nervousness, depression, fatigue, headache, frequent urination and bladder pain.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017012510687N4
Registration date: 2017-02-26, 1395/12/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-26, 1395/12/08
Registrant information
Name
Somaye Ansari
Name of organization / entity
School of Nursing and Midwifery, JundiShapur University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 916 800 7396
Email address
ansari-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ground floor, Ahvaz Junishapur University of Medical Science and Health Services of Department Research Development and Technological, Academic city, Ahvaz
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Hypericum on menopause early symptom
Public title
The effect of Hypericum on menopause early symptom
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: age 60-45 years; amenorrhea for at least 12 months; there are at least two menopause of symptom according to Kupperman index; having read and write. Exclusion criteria: women with amenorrhea due to the abnormal menopause; hysterectomy, oophorectomy and radiation therapy; known systemic diseases such as endocrine disorders (thyrotoxicosis); dietary intake of phytoestrogens and the whole regime; having known physical and mental diseases;consumption sexual hormones; sensitivity to herbal drugs; women athletes; consumption antidepressants drug; herbal medicines; higher body mass index30
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

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz JundiShapur University of Medical Sciences and Health Services of Ethics Committee
Street address
Ahvaz Jundishapur University of Medical Science and Health Services, Golestan BLV, Ahvaz
City
Ahvaz
Postal code
61357-15794
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
8-20-4411-پ

Health conditions studied

1

Description of health condition studied
menopause early symptom
ICD-10 code
N95.3
ICD-10 code description
States assosiated with artificial menopaus

Primary outcomes

1

Description
menopause early symptom
Timepoint
Before intervention, 2 weeks after intervention, 4 weeks after the intervention, 6 weeks after the intervention, 8 week after interventionention
Method of measurement
kupperman index questionarie

Secondary outcomes

1

Description
Side effects of Hypericum
Timepoint
2 week after intervention, 4 week after intervention, 6 week after intervention, 8 week after intervention
Method of measurement
Questionarie

Intervention groups

1

Description
Perforating tablet contains 330 mg hypericin 3 times daily in intervention group will be administered for 8 weeks. Information collected through interviews and questionnaires individual characteristics and symptoms will be collected Kupperman index. Kupperman Index is based on nine symptoms of menopause include hot flashes in, night sweats, insomnia, nervousness, depression, fatigue, headache, frequent urination and bladder pain. Kupperman questionnaire will be completed for participant before the study and at weeks 2, 4, 6 and 8 weeks after the start of the intervention.
Category
Treatment - Drugs

2

Description
In controlled group will be placebo for three times a day for 8 weeks.Kupperman questionnaire will be completed for participant before the study and at weeks 2, 4, 6 and 8 weeks after the start of the intervention.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Eeast Health Center
Full name of responsible person
Shahnaz Najar
Street address
Ahvaz Eeast Health Center, facing the Haftetir Park, Rastegari Street, Ayatollah Behbahani highway, Ahvaz
City
Ahvaz

2

Recruitment center
Name of recruitment center
Ahvaz west Health Center
Full name of responsible person
Shahnaz Najar
Street address
Ahvaz west Health Center, Kiyan abad, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Doctor Behzad Sharif Makhmalzadeh
Street address
Ground floor, Ahvaz Junishapur University of Medical Science and Health Services of Department Research Development and Technological, Academic city, Ahvaz
City
Ahvaz
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, Ahvaz Jundishapur University of Medical Science
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
School of Nursing and Midwifery, JundiShapur University of Medical Sciences and Health Services
Full name of responsible person
Somaye Ansari
Position
Masters of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz JundiShapur University of Medical Sciences and Health Services , Golestan BlV, Ahvaz
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
ansari-s@ajums.ac.ir؛ilnaz.zohrabi67@gmail.com
Web page address
www.fnursing.ajums.ac.ir؛www.ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Science and Health Services
Full name of responsible person
Shahnaz Najar
Position
Master of Midwifery/Academic Board
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz JundiShapur University of Medical Sciences and Health Services , Golestan BlV, Ahvaz
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3373 8070
Fax
+98 61 3373 8331
Email
Najarshahnaz@yahoo.com; ansari-s@ajums.ac.ir
Web page address
www.fnursing.ajums.ac.ir؛www.ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Masters of Midwifery * مدرک/سمت School of Nursing and Midwifery, JundiShapur University of Medical
Full name of responsible person
Somye Ansari
Position
Masters of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz JundiShapur University of Medical Sciences and Health Services , Golestan BlV, Ahvaz
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3373 8070
Fax
+98 61 3373 8333
Email
ansari-s@ajums.ac.ir;ilnaz.zohrabi67@gmail.com
Web page address
www.ajums.ac.ir؛ www.fnursing.ac.ir

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
Loading...