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The effect of saffron petal capsule on the monthly cycle pattern and symptoms of clinical and biochemical hyperandrogenism in women with polycystic ovary syndrome

Protocol summary

Study aim
Determining the effect of saffron petal capsules on the monthly cycle pattern and clinical and biochemical hyperandrogenism symptoms in women with polycystic ovary syndrome.
Design
A placebo-controlled, three-blind, randomized phase 2 clinical trial on 80 patients will be used for randomization using PASS version 11 software
Settings and conduct
Place of study: women's clinics of educational hospitals in Mashhad; Study population: 80 women referring to women's clinics of educational hospitals in Mashhad; Type of blinding: three blinds; How to blind: saffron petal capsules and placebo will be put in completely similar capsules and cans, which are similar in shape and color, and only the pharmacist consultant will know about the assigned codes
Participants/Inclusion and exclusion criteria
Women of reproductive age (15-45 years), with pcos according to Rotterdam criteria, normal puberty, normal thyroid test, low FSH level; Non-entry: Suffering from certain medical diseases, having a history of surgery, having a history of laser treatment in the upper lip, chin, chest and lower abdomen and drug treatment in the last two months, having an allergy to saffron and its petal medicines, smoking and Hookah, suffering from premature menopause
Intervention groups
Intervention group: 30 mg capsules of saffron petals made in the pharmacology department of medicinal plants of Mashhad University of Medical Sciences will be used daily for 3 months. Control group: A placebo capsule containing Avicel made in the Pharmacology Department of Medicinal Plants of Mashhad University of Medical Sciences will be used once a day for 3 months.
Main outcome variables
Menstrual cycle pattern, clinical and biochemical symptoms of hyperandrogenism

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240414061487N1
Registration date: 2024-04-21, 1403/02/02
Registration timing: prospective

Last update: 2024-04-21, 1403/02/02
Update count: 0
Registration date
2024-04-21, 1403/02/02
Registrant information
Name
Fatemeh Feizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
feizif4012@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-08-04, 1403/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of saffron petal capsule on the monthly cycle pattern and symptoms of clinical and biochemical hyperandrogenism in women with polycystic ovary syndrome
Public title
Effect of saffron petals in treatment of polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women of reproductive age (15-45 years old) of Iranian descent fluent in Persian Literate to read and write receiving and signing written consent suffering from pcos according to Rotterdam criteria normal puberty normal thyroid test low FSH levels
Exclusion criteria:
Having medical diseases (heart, liver, digestive and kidney, diabetes, blood pressure) having a history of surgery in the last two months having a history of laser in the area of ​​the upper lip, chin, chest and lower abdomen in the last two months drug treatment (antidiabetic drugs such as insulin, antihypertensive drugs, Sedative) in the last two months being allergic to saffron and its petal medicines using cigarettes and hookah suffering from premature menopause
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign eligible people to two groups, we use four and two combined blocks, for this assignment we use PASS version 11 software. By generating random numbers, this software creates 4-long blocks of letters A and B that have two A's and two B's. We put these letters together and number them from 1 to 80 and put each letter in an envelope and write its number on the envelope. which we put inside are allocated
Blinding (investigator's opinion)
Triple blinded
Blinding description
1. Using a placebo that is completely similar to the saffron petal capsule in terms of shape, color and size. 2. After allocating the people, the relevant group will be placed inside the sealed envelope, which will be assigned to two groups in order of entry
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of School of Nursing and Midwifery, Mashhad University of Medical Sciences
Street address
Nursing and Midwifery School , Shahid Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.138

Health conditions studied

1

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

Primary outcomes

1

Description
Menstrual cycle pattern
Timepoint
Before the study and 3 months after the intervention
Method of measurement
Questionnaire made by the researcher on the pattern of menstrual cycle

2

Description
Hirsutism
Timepoint
Before the study and 3 months after the intervention
Method of measurement
Freeman Galloway form

3

Description
Symptoms of biochemical hyperandrogenism
Timepoint
Before the study and 3 months after the intervention
Method of measurement
Taking a blood sample

4

Description
Acne
Timepoint
Before the study and 3 months after the intervention
Method of measurement
Global Acne Grading system

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 30 mg capsules of saffron petals made in the pharmacology department of medicinal plants of Mashhad University of Medical Sciences will be used daily for 3 months.
Category
Treatment - Drugs

2

Description
Control group: A placebo capsule containing Avicel made in the Pharmacology Department of Medicinal Plants of Mashhad University of Medical Sciences will be used once a day for 3 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Women's clinics of teaching hospitals in Mashhad
Full name of responsible person
Fatemeh Erfanian Arghavani
Street address
Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ErfanianF@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mahmood Shabestary
Street address
Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
ّFatemeh Feizi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery School , Shahid Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
FeiziF4012@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Erfanian Arghavani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery School , Shahid Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ErfanianF@muma.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Feizi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery School , Shahid Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
FeiziF4012@mums.ac.ir

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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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