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Clinical trial of Comparing the effect of Achillea Millefolium capsules and Mefenamic Acid on the amount and duration of menstrual bleeding in women affected by menorrhagia

Protocol summary

Summary
This study is conducted to determine the effect of Achillea Millefolium capsule on menorrhagia. In this clinical trial, 90 women with complaint of heavy menstrual bleeding were selected and after a control cycle for evaluating the primary bleeding volume, were randomly allocated to Achillea Millefolium or control groups. Inclusion criteria: Affected by menorrhagia, No history of known systemic or pelvic inflammatory diseases, Not pregnant, No consumption of specific medications,No abnormal pap smear or ultrasonography, No history of sensitivity to medicinal plants. Exclusion criteria: sensitivity to the study medications, Failure to adhere to prescribed treatment, , Unwilling to continue participation in the study,Tacking any herbal or chemical drug during the study. Both groups were subjected to mefenamic acid capsule with 500 mg every 8 hours,from the first day to the end of bleeding,up to seven days, for two consecutive cycles.In Achillea Millefolium group, , in addition to mefenamic acid, Achillea Millefolium capsules, two capsules every 12 hours per day,from the first day to the end of bleeding,up to seven days , were prescribed.In control group, instead of Achillea Millefolium capsules,placebo of Achillea Millefolium was prescribed with the same order. Data on the amount and duration of bleeding were checked and compared before and after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016073029126N1
Registration date: 2017-07-30, 1396/05/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-30, 1396/05/08
Registrant information
Name
Pegah matoury
Name of organization / entity
medical science of tehran
Country
Iran (Islamic Republic of)
Phone
+98 31 4524 5616
Email address
p-matourypour@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Clinical trial of Comparing the effect of Achillea Millefolium capsules and Mefenamic Acid on the amount and duration of menstrual bleeding in women affected by menorrhagia
Public title
The effect of Achillea Millefolium on heavy menstrual bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Affected by menorrhagia, Regular menstrual cycles,Body mass index between18.5- 29.5,Age between 18-45 years,No history of known systemic or pelvic inflammatory diseases, Not pregnant, No consumption of specific medications,No abnormal pap smear or ultrasonography, No history of sensitivity to medicinal plants. Exclusion criteria: Pregnancy during the study, Failure to adhere to prescribed treatment, sensitivity to the study medications, Unwilling to continue participation in the study,Occurrence a specific disease,Taking any herbal or chemical drug during the study,Occurrence of a specific event during the study.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study has been done by triple blind method. To do this, patients, researcher and statistical consultant were not aware of prescribed drug's nature. 90 women using Excel software, were randomly allocated to Achillea Millefolium or control groups.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak of University of Medical Sciences
Street address
Beside Amir almomenin hospital, Sardasht St, Basij Sq,Arak
City
Arak
Postal code
Approval date
2015-11-07, 1394/08/16
Ethics committee reference number
IR.ARAKMU.REC.1394.181

Health conditions studied

1

Description of health condition studied
Menorrhagia
ICD-10 code
N92-0
ICD-10 code description
excessive and frequent menturation with regular cycle

Primary outcomes

1

Description
Amount of bleeding
Timepoint
before treatment، First month during treatment, second month during treatment
Method of measurement
Higam Chart

2

Description
Duration of bleeding
Timepoint
before treatment، First month during treatment, second month during treatment
Method of measurement
Higam Chart

Secondary outcomes

1

Description
Side effects of medication
Timepoint
2 months after treatment
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention 1: In control group, Mefenamic acid capsule 500 mg every 8 hours and placebo capsules 500 mg per day every 12 hours, were prescribed from the first day to the end of bleeding up to seven days.
Category
Placebo

2

Description
Intervention 2: In Achillea Millefolium group, Mefenamic acid capsules, 500 mg every 8 hours and hydro alcoholic extract of Achillea Millefolium capsules, 500 mg per day every 12 hours,were prescribed, from the first day to the end of bleeding up to seven days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Clinic
Full name of responsible person
Street address
Masjed Seyedha Av, Emam St, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Ali Ghazaavi
Street address
Beside Amir almomenin hospital, Sardasht St, Basij Sq, Arak
City
Arak
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, Arak University of Medical Sciences
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 Of Arak
Full name of responsible person
Katayoun Vakilian
Position
Reproductive Health phd
Other areas of specialty/work
Street address
Beside Amir almomenin hospital, Sardasht St, Basij Sq, Arak
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3524
Fax
Email
Dr.vakilian@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Nasim Khaademi
Position
Master of midwifery
Other areas of specialty/work
Street address
Islamic Azad University,Najafabad,Esfahan
City
Najafabad
Postal code
Phone
+98 31 4229 2530
Fax
Email
Khademi_nasim@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifey
Full name of responsible person
Nasim Khaademi
Position
Master of midwifery
Other areas of specialty/work
Street address
Islamic Azad University,Najafabad, Esfahan
City
Najafabad
Postal code
Phone
+98 31 4229 2530
Fax
Email
Khademi_nasim@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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