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Investigation on effect of mixed herbal medicines (fennel,chamomile,saffron)on menopausal syndrome and hormonal changing and quality of life in menopausal women in Mashhad with 4 groups in different doses and placebo controlled

Protocol summary

Summary
objective: The aims of this study are the Investigation effect of mixed herbal medicines on menopausal syndrome , quality of life and hormones changes. Design & Setting and conduct: a triple blind randomized clinical trial study and placebo controlled trial conducted on 120 menopausal women for 12 weeks in Mashhad. The participants randomly allocated based on age, in four groups.Group Placebo (C),group A (250 mg chamomile+30 mg fennel+15 mg saffron), group B (100 mg chamomile+120 mg fennel+60 mg saffron) and group D (500 mg chamomile+600 mg fennel+30 mg saffron). All participants take 25 drops of mixed herbal medicines extracts daily. Intervention: all participants completed demographic, MRS questioner, quality of life questioner at the beginning, at the 6th week and at the end of trial .Then one group take placebo, the other group take low-dose of extract, third group take medium-dose of extract and last group take high dose of the extract daily for 12 weeks. Also laboratory tests (estrogen, progesterone, Testosterone and LH, FSH)are done at the first and at the end of the intervention. Main Outcome measures: Menopause symptoms ,Quality of life and hormones changes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092429950N1
Registration date: 2017-05-29, 1396/03/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-05-29, 1396/03/08
Registrant information
Name
Mitra Mahdavian
Name of organization / entity
Mashhad university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 9739
Email address
mahdavianm911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical science
Expected recruitment start date
2016-04-29, 1395/02/10
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation on effect of mixed herbal medicines (fennel,chamomile,saffron)on menopausal syndrome and hormonal changing and quality of life in menopausal women in Mashhad with 4 groups in different doses and placebo controlled
Public title
Investigation on effect of mixed herbal medicines (fennel,chamomile,saffron) on menopausal syndrome,hormonal changing and quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: lack of menstruation in last 12 months; having tested showed the evidence of menopause; having menopausal syndrome; the range of the age is between 45 - 65 years. Exclusion criteria : using anti-anxiety drugs; using antidepressants; using hormones such as: estrogen and progesterone in the last 6 months; using anticoagulant and NSAIDs such as: ibuprofen; having asthma and allergies; thyroid diseases; psychosomatic disorders; pheochromocytoma; carcinoma; leukemia; cancer; lack of proper use of herbal medicines in this study; creating skin irritation and allergy drug.
Age
From 45 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
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
Ethics committee of Mashhad university of medical science
Street address
Central department NO1, 18 th Daneshgah , Daneshgah Ave,Mashhad
City
Mashhad
Postal code
9138813944
Approval date
2015-11-07, 1394/08/16
Ethics committee reference number
IR.MUMS.REC..1394.499

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
N 95.1
ICD-10 code description
is a billable/specific ICD-10-CM code that can be used to indicate a diagnosis for reimbursement purposes. This is the American ICD-10-CM version of N95.1. Other international versions of ICD-10 N95.1 may differ.

Primary outcomes

1

Description
Menopausal syndrome
Timepoint
At the beginning of the study,6 weeks later and 12 weeks later at the end of intervention
Method of measurement
Menopause Rating Scale (MRS)

2

Description
Quality of life
Timepoint
At the beginning of the study,6 weeks later and 12 weeks later at the end of intervention
Method of measurement
Quality of life questioner(QOL)

3

Description
Hormones changes
Timepoint
At the beginning of the study and 12 weeks later at the end of intervention
Method of measurement
Laboratory measurements

Secondary outcomes

1

Description
Depression
Timepoint
at the beginning,6 weeks later and 12 weeks later at the end of intervention
Method of measurement
Beck questioner

2

Description
Insomnia
Timepoint
at the beginning,6 weeks later and 12 weeks later at the end of intervention
Method of measurement
ISI questioner

Intervention groups

1

Description
Group 1 low dose: 250 mg chamomile+30 mg fennel+15 mg saffron ,25 drops daily
Category
Treatment - Drugs

2

Description
Group 2 high dose: 1000 mg chamomile+120 mg fennel+60 mg saffron,25 drops daily
Category
Treatment - Drugs

3

Description
Group 3 placebo:sterile dH2O,25 drops daily
Category
Treatment - Drugs

4

Description
Group 4 intermediate dose : 500 mg chamomile+60 mg fennel+30 mg saffron,25 drops daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
All over the city ,Mosque,Religious ceremony
Full name of responsible person
because of lack participant in treatment centers we decided take the sample in all over the city wit
Street address
Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Mashhad university of medical science
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Central department No 1,18th Daneshgah, Daneshgah Ave
City
Mashhad
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 and Technology of Mashhad 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
Mashhad university of medical science
Full name of responsible person
Dr. Khadije Mirzaii
Position
P.h.D in Reproductive health/academic staff
Other areas of specialty/work
Street address
Daneshgah Ave.university of Nursing &Midwifery
City
Mashhad
Postal code
Phone
+51 38591513
Fax
Email
mirzaiikh@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing &Midwifery
Full name of responsible person
Dr khadije Mirzaii
Position
P.h.D in Reproductive health/academic staff
Other areas of specialty/work
Street address
Daneshgah Ave,Faculty of Nursing &Midwifery
City
Mashhad
Postal code
Phone
+51 38591511
Fax
Email
mirzaiikh@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing &Midwifery
Full name of responsible person
Mitra Mahdavian
Position
Msc, student of P.h.D in Reproductive health
Other areas of specialty/work
Street address
Daneshgah Ave,faculty of Nursing &Midwifery
City
Mashhad
Postal code
Phone
+51 38591511
Fax
Email
mahdavianm911@mums.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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