Protocol summary

Summary
This study is a clinical trial designed to determine the effect of valerian, lemon balm oral capsules and their combined consumption on the symptoms of menopause in women aged 45-60. 120 healthy postmenopausal volunteers referred to Imam Khomeini clinic and Imam Hussein clinic (30 persons in each group) eligible of entry criteria (cessation of menstruation for at least 12 months due to menopause, no history of allergy to valerian, lemon balm, and their combination, etc.) were enrolled into the study after completing informed consent. Exclusion criteria were including any adverse effects during treatment including allergies to treatment capsules and no consumption of them to a maximum period of seven days or more per month of consumption, drug use, occurrence of any individual or family crises, and changes in diet and lifestyle such as changes to vegetarianism, health or addiction problems throughout research process. The subjects include three groups: treated with valerian, lemon balm, their combined form and the control group. The treatment group received 530 mg capsules of valerian (plant roots), or 250 mg Lemon Balm (plant leaves), or a combination of 160 mg valerian and 80 mg lemon balm, or 300 mg starch (controls) (capsules of the same form twice a day for eight weeks). The instruments of study consisted of demographic questionnaire, treatment registration forms and instrument of menopause evaluation criteria (physical, psychological and genitourinary dimensions) recorded and compared before treatment and then four and eight weeks after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201405312172N17
Registration date: 2014-08-09, 1393/05/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-09, 1393/05/18
Registrant information
Name
Simin Taavoni
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 8161
Email address
staavoni@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Vice Chancellor for Research, Iran University of Medical Sciences.
Expected recruitment start date
2014-07-06, 1393/04/15
Expected recruitment end date
2014-12-06, 1393/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of valerian, lemon balm and combined valerian-lemon balm oral capsules on severity of menopausal symptoms in women aged 45-60
Public title
The effect of valerian, lemon balm and combined valerian-lemon balm oral capsules on severity of menopausal symptoms in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: cessation of menstruation at least for 12 months due to menopause; no history of allergy to valerian, lemon balm and both of them; no history of drug use in the past two months, such as hormone replacement therapy and psychotic drugs etc. Exclusion Criteria: any kind of side effects during treatment such as allergy to valerian, lemon balm and both of them; no taking of oral capsules valerian, lemon balm and both of them for a maximum period of seven days or more during any month of consumption; using any kind of drug throughout the study; occurrence of any individual or family crisis during research process; any kind of change in diet and life style such as changing to vegetarianism diet during the research process; any health problems or addictions throughout research process.
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
None
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice Chancellor for Research, Iran University of Medical Sciences
Street address
Vice Chancellor for Research, Iran University of Medical Sciences, Close to Milad Tower, Hemat Highway
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Approval date
2014-07-11, 1393/04/20
Ethics committee reference number
102052

Health conditions studied

1

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

2

Description of health condition studied
menopause
ICD-10 code
N95.3
ICD-10 code description
States associated with artificial menopause

Primary outcomes

1

Description
Hot flush
Timepoint
Before intervention, at the end of first and second month after intervention
Method of measurement
Menopause Rating Scale Questionnaire

2

Description
Depression
Timepoint
Before intervention, at the end of first and second month after intervention
Method of measurement
Menopause Rating Scale Questionnaire

3

Description
Tachycardia
Timepoint
Before intervention, at the end of first and second month after intervention
Method of measurement
Menopause Rating Scale Questionnaire

4

Description
Insomnia
Timepoint
Before intervention, at the end of first and second month after intervention
Method of measurement
Menopause Rating Scale Questionnaire

5

Description
Anxiety
Timepoint
Before intervention, at the end of first and second month after intervention
Method of measurement
Menopause Rating Scale Questionnaire

6

Description
Vaginal dryness
Timepoint
Before intervention, at the end of first and second month after intervention
Method of measurement
Menopause Rating Scale Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: Oral use of 530 mg Valerian capsules, twice a day, for two months
Category
Prevention

2

Description
Intervention 2: Oral use of 250 mg Lemon Balm capsules, twice a day, for two months
Category
Prevention

3

Description
Intervention 3: Oral use of 80 mg Lemon Balm and 160 mg Valerian combined capsule, twice a day, for two months
Category
Prevention

4

Description
Placebo Group: Oral use of 300 mg starch capsules, twice a day, for two months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini Health Center
Full name of responsible person
Dr.Bahram Rezaii
Street address
Emam Khomeini Health Center, Saat Square,Ghods (Ghalee Hassan Khan) City, Karaj Former Road
City
Tehran
Country
Iran (Islamic Republic of)

2

Recruitment center
Name of recruitment center
Emam Hossein Health Center
Full name of responsible person
Dr.Mina Hosseini
Street address
Emam Hosseini Health Center, Shahid Aalami Street, Ghods (Ghalee Hassan Khan) City, Karaj Former Road
City
Tehran
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Cheraghi
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Dr Mirkhany St. (N.East), Tohid Square
City
Tehran
Country
Iran (Islamic Republic of)
Grant name
پایان نامه
Grant code / Reference number
23441
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran University of Medical Sciences (Reserach proposal)
Full name of responsible person
Dr. Seied Ali Javad Mosavi
Street address
Vice Chancellor for Research, Iran University of Medical Science, Close to Milad Tower, Hemat Highway
City
Tehran
Country
Iran (Islamic Republic of)
Grant name
طرح پژوهشی
Grant code / Reference number
23441
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Iran University of Medical Sciences (Reserach proposal)
Proportion provided by this source
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
Nursing and Midwifery Faculty of Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
Senior Lecturer, Head of Midwifery Continuing Education Office, Nursing and Midwifery Faculty, Iran
Other areas of specialty/work
Street address
3rd Floor, No.12, Nadjmabady St. Kazeroon St. Mirdamad Ave
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1996713883
Phone
+98 21 8820 8161
Fax
Email
staavoni14@yahoo.com, staavoni@iums.ac.ir
Web page address
www.iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
Senior Lecturer, Head of Midwifery Continuing Education Office, Nursing and Midwifery Faculty, Iran
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty of Iran University of Medical, In opposition of Khatamol Anbia Hospital, Rashid Yasami St., Valiaasr Ave.
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1996713883
Phone
+98 21 8820 8161
Fax
Email
staavoni14@yahoo.com, staavoni@iums.ac.ir
Web page address
www.iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
Senior Lecturer, Head of Midwifery Continuing Education Office, Nursing and Midwifery Faculty, Iran
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty of Iran University of Medical, In opposition of Khatamol Anbia Hospital, Rashid Yasami St., Valiaasr Ave.
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1996713883
Phone
+98 21 8820 8161
Fax
Email
staavoni14@yahoo.com, staavoni@iums.ac.ir
Web page address
www.iums.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
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