Determining the effect of anise consumption on weight loss and anthropometric indicators of women with polycystic ovaries referred to the infertility center of Sabzevar University of Medical Sciences.
Design
A controlled, parallel-group, single-strain clinical trial study on 80 patients
Settings and conduct
In this clinical trial study, patients referred to the infertility center of Sabzevar University of Medical Sciences diagnosed with polycystic ovary syndrome (based on the Rotterdam criteria and approved by gynecologists) will be included in the study after obtaining the necessary permits and the approval of the ethics committee. In order to blind the study, the drugs will be prepared in similar and non-transparent packages and the samples will be delivered after coding.
Participants/Inclusion and exclusion criteria
Entry criteria: diagnosis of polycystic syndrome by a gynecologist based on the Rotterdam criteria (oligomenorrhea or menstrual disorders, clinical or laboratory symptoms of hyperandrogenism, evidence of polycystic ovary in ultrasound)
Ages between 18-45 years
Body mass more than 25
Consent to participate in the study
Non-entry criteria:
Having diabetes
Taking weight loss drugs
Participating in intervention studies at the same time
Suffering from severe acute and chronic physical diseases
Intervention groups
The intervention group receives 5 grams of anise powder half an hour before lunch and dinner every day for 8 weeks. The control group will receive a placebo (corn starch) in the same way.
Main outcome variables
Weight and anthropometric indicators; BMI; Abdominal circumference size; ratio of waist circumference to hip circumference; Appetite rate ;quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240712062400N1
Registration date:2024-08-19, 1403/05/29
Registration timing:prospective
Last update:2024-08-19, 1403/05/29
Update count:0
Registration date
2024-08-19, 1403/05/29
Registrant information
Name
Shaqayeq Fakhrian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4263 2943
Email address
shaqayeqfakhrian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate of anisum consumption on anthropometric indicators of infertile women
Public title
Investigate of anisum consumption on anthropometric indicators of infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of polycystic syndrome by gynecologist based on Rotterdam criteria
Body mass more than 25
Consent to participate in the study
Exclusion criteria:
Having diabetes
Taking weight loss drugs
Participating in intervention studies at the same timeCommunity Verified icon
Suffering from severe acute and chronic physical diseasesCommunity Verified icon
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial study, patients referred to the Infertility Center of Sabzevar University of Medical Sciences diagnosed with polycystic ovary syndrome (based on the Rotterdam criteria and approved by gynecologists) will be included in the study after obtaining the necessary permits and the approval of the ethics committee.The diagnosis of polycystic syndrome will be given by the gynecologist and obstetrician based on the Rotterdam criteria (oligomenorrhea or menstrual disorders, clinical or laboratory symptoms of hyperandrogenism, the presence of evidence of polycystic ovary in ultrasound), where the presence of two of the three criteria is sufficient for diagnosis. The study samples are divided into two intervention and control groups by random block division. Medicines will be prepared in similar and non-transparent packages and samples will be delivered after coding.
Blinding (investigator's opinion)
Single blinded
Blinding description
The intervention group receives 5 grams of anise powder half an hour before lunch and dinner every day for 8 weeks. The control group will receive a placebo (corn starch) in the same way. Medicines will be prepared in similar and non-transparent packages and samples will be delivered after coding.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
nuclear martyrs boulevard, above the tomb of unknown martyrs, campus of Sabzevar University of Medical Sciences
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2024-07-08, 1403/04/18
Ethics committee reference number
402233
Health conditions studied
1
Description of health condition studied
Investigating the effect of anise consumption on weight loss and anthropometric indicators of women with polycystic ovary syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
weight
Timepoint
Before starting the intervention and after 8 weeks (completion of the study)
Method of measurement
sinker
2
Description
height
Timepoint
Before starting the intervention and after 8 weeks (completion of the study)
Method of measurement
meter
3
Description
round abdomen
Timepoint
Before starting the intervention and after 8 weeks (completion of the study)
Method of measurement
meter
4
Description
round the hips
Timepoint
Before starting the intervention and after 8 weeks (completion of the study)
Method of measurement
meter
5
Description
round the wrist
Timepoint
Before starting the intervention and after 8 weeks (completion of the study)
Method of measurement
meter
6
Description
appetite
Timepoint
Before starting the intervention and after 8 weeks (completion of the study)
Method of measurement
Visual Analogue Scale
7
Description
physical activity
Timepoint
Before starting the intervention and after 8 weeks (completion of the study)
Method of measurement
questionnaire
8
Description
quality of life
Timepoint
Before starting the intervention and after 8 weeks (completion of the study)
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They receive 5 grams of anise powder half an hour before lunch and dinner for 8 weeks.
Category
N/A
2
Description
Control group: They receive 5 grams of placebo (corn starch) half an hour before lunch and dinner for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility clinic of Sabzevar University of Medical Sciences
Full name of responsible person
Shaqayeq fakhrian
Street address
No. 77, 4th floor, West Amozgar Ave ,Amozgar Blvd., Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9318785191
Phone
+98 51 4263 2943
Email
shaqayeqfakhrian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Kazem Hasanpour
Street address
No. 77, 4th floor, West Amozgar Ave ,Amozgar Blvd., Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9318785191
Phone
+98 51 4263 2943
Email
shaqayeqfakhrian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Shaqayeq Fakhrian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Traditional Medicine
Street address
No. 77, 4th floor, West Amozgar Ave ,Amozgar Blvd., Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9318785191
Phone
+98 51 4263 2943
Fax
Email
shaqayeqfakhrian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Shaqayeq Fakhrian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Traditional Medicine
Street address
No. 77, 4th floor, West Amozgar Ave ,Amozgar Blvd., Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9318785191
Phone
+98 51 4263 2943
Fax
Email
shaqayeqfakhrian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Shaqayeq Fakhrian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Traditional Medicine
Street address
No. 77, 4th floor, West Amozgar Ave ,Amozgar Blvd., Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9318785191
Phone
+98 51 4263 2943
Fax
Email
shaqayeqfakhrian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available