Protocol summary

Summary
The aim of the study is to explore the effects of the raw extracts of the herbs asafetida and fennel on polycystic ovary syndrome (PCOS). The study is a triple-blind randomized clinical trial. The study population consists of female students aged 15-30 years who complain of oligomenorrhea and obtain a score of at least 8 on Ferriman–Gallwey questionnaire. The subjects who are not willing to participate in the study, or have used medication over the past three months, or have participated in a similar study are excluded. Materials and methods: 45 of the participants whose hirsutism scores according to Ferriman–Gallwey questionnaire were 8 or above underwent sonography for determination of their ovarian morphology. In addition, blood samples were taken for measurement of their sex hormones. Subsequently, the 45 participants were randomly divided into three groups to receive one of the three interventions of placebo, asafetida and fennel for two months, twice daily. At the end of the interventions, the participants' degrees of hirsutism were re-evaluated using Ferriman–Gallwey questionnaire and the sonography and blood sample collection were repeated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016040427207N1
Registration date: 2016-11-12, 1395/08/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-12, 1395/08/22
Registrant information
Name
Fatemeh Ghavi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71543404059
Email address
fghavi@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Dr Kavous Solhju: Vice Chancellor for Research
Expected recruitment start date
2012-06-30, 1391/04/10
Expected recruitment end date
2015-05-23, 1394/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ferrula assa foetida and Fennle on improving PCOs women who refer to clinic
Public title
Effect of Ferrula assa foetida and Fennle on improving PCOs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: student girls aged 15-30 years were complained of oligo/amenorrhea; hirsutism score ≥8 based on Ferriman-Galway scale. Exclusion criteria: history of medical treatment from 3 months age; participation in another study; no willing to participate in this study.
Age
From 15 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Jahrom University of Medical Sciences
Street address
Ostad Motahari Blv
City
Jahrom
Postal code
Approval date
2014-06-18, 1393/03/28
Ethics committee reference number
Jums.REC.1393.023

Health conditions studied

1

Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
pcos syndrom
Timepoint
befor intervention,third after intervention
Method of measurement
sonography,freriman-galway(f-g scale),hormonal changes

2

Description
improving PCOs symptoms
Timepoint
before the study, 3 month after the study
Method of measurement
Hormonal chnges, sonography parameters, Ferriman-Galway (F-G scale) score

Secondary outcomes

1

Description
Sonographic data
Timepoint
before the intervention, 3 months after the intervention
Method of measurement
Sonography system

2

Description
Hirsotism Score of Freman-Galway
Timepoint
before the intervention
Method of measurement
Questionnaire of Freman_Galway

3

Description
Hormonal changes
Timepoint
before the intervention, 3 months after the intervention
Method of measurement
Elisa Methode

Intervention groups

1

Description
Oral capsules of 100 mg Ferrula assa-foetida for 3 months twice a day
Category
Treatment - Drugs

2

Description
Oral capsules of 100 mg Fennle for 3 months twice a day
Category
Treatment - Drugs

3

Description
Oral capsules of 100 mg placebo for 3 months twice a day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Jahrom University of Medical Sciences
Full name of responsible person
Fatemeh Ghavi
Street address
City
Jahrom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom univercity of medical scinces
Full name of responsible person
Dr Kavous Solhju
Street address
fars, jahrom, jahrom univercity of medical scinces
City
jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom univercity of medical scinces
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
Jahrom University of Medical Sciences
Full name of responsible person
fatemeh Ghavi
Position
Instructor of faculty member of nursing and midwifery school
Other areas of specialty/work
Street address
Fars
City
Jahrom
Postal code
7414846199
Phone
+98 71 5433 6085
Fax
Email
ghavi.fatemeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
fatemeh Ghavi
Position
Instructor of faculty member of nursing and midwifery school
Other areas of specialty/work
Street address
Fars
City
Jahrom
Postal code
7414846199
Phone
+98 71 5433 6085
Fax
Email
ghavi.fatemeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Fatemeh Ghavi
Position
Instructor of faculty member of nursing and midwifery
Other areas of specialty/work
Street address
Jahrom, Motahari Blv
City
Jahrom
Postal code
7414846199
Phone
+98 71 5433 6085
Fax
Email
ghavi.fatemeh@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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