Protocol summary

Study aim
The aim of this study is to investigate the effect of Sumac powder on antioxidant indices and Uric acid in women with polycystic ovary syndrome who reffering to Akbar Abadi Hospital.
Design
The clinical trial has a control group, double-blind, and randomized. For randomization, a random block method with four block was used. The number of samples in each group was 37, which is assumed to be 15 percent reduction, 44 people were considered in each group.
Settings and conduct
This study is a randomized, double-blind clinical trial (patient and researcher). The place of study is Akbar Abadi Hospital. The number of 88 patients with polycystic ovary syndrome after the examination by a Gynecologist, filling out the demographic questionnaire, 24-hour recall, physical activity is divided into two groups in each group1- intervention group receives sumac powder 2- control group receives starch randomly( 3 capsules each capsule containing 1gr) . The placebo prepares with the same appearance and randomly divides it into patients. To compare the two groups at the beginning and after the study, Antioxidant indices and Uric acid will evaluate.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the patient's with polycystic ovary syndrome; Age between 20 and 40; Written consent of the patient. Non-inclusion criteria: reluctance to participate in the plan; ; conditions that affect insulin sensitivity, inflammation or lipid profile and hormonal profile.
Intervention groups
Intervention group: Patients who have inclusion criteria and receive one capsule contains 3 gr sumac powder. Control group: Patients who have inclusion criteria receive 3 gr Starch for three months.
Main outcome variables
Malondialdehyde; glutathione peroxidase; superoxide dismutase; total antioxidant capacity and uric acid

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120415009472N21
Registration date: 2020-01-06, 1398/10/16
Registration timing: retrospective

Last update: 2020-01-06, 1398/10/16
Update count: 0
Registration date
2020-01-06, 1398/10/16
Registrant information
Name
Naheed Aryaeian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4750
Email address
aryaeian.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2019-11-19, 1398/08/28
Actual recruitment start date
2018-04-04, 1397/01/15
Actual recruitment end date
2019-11-19, 1398/08/28
Trial completion date
2019-11-19, 1398/08/28
Scientific title
Effect of Sumac powder on Antioxidant indices and Uric Acid in women with polycystic ovary syndrome
Public title
Effect of Sumac in treatment of polycystic ovary syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Polycystic ovary Syndrome based on two criteria of the three diagnostic criteria of the disease based on Rotterdam: 1.Bleeding is reduced or discontinued (as Delay more than 35 days or less than 8 bleeding episodes per year) 2. Clinical symptoms including hirsutism or Ferriman-Gallway (MGF) score above 8, acne and male pattern baldness and biochemical symptoms of increased androgenesis. 3. Polycystic ovary (12 or more of 12 follicles per ovary with a diameter of 2 to 9 mm, or an increase in ovarian volume to more than 310 ml). Patients with age between 20 to 40 years old. patient's acceptance of taking part in the study.
Exclusion criteria:
Those who take drugs of anticoagulants and hyperlipidemia Use Tobacco Having kidney disease, diabetes, liver disease, cardiovascular disorders, hypothyroidism, inflammatory and rheumatic diseases, hyperprolactinemia, Cushing's syndrome, and congenital adrenal hyperplasia Follow a particular diet in the last three months. Take medications that affect insulin sensitivity, inflammation, or lipid profile and hormonal profile, including glucocorticoid drugs, ovulation induction drugs, anti-obesity, anti-diabetes, antihypertensive, estrogenic, anti-androgen, over the past 3 months Unwilling to participate in the study Use of Nutrition Supplements in the last 2 months Pregnancy or breastfeeding Sensitization or allergy to sumac
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 88
Actual sample size reached: 75
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the method of block randomization will be used with quadrilateral blocks. According the sample size of 88, the 22 quadruple blocks will be produced. For the purpose of concealment in the randomization process, individual codes will be used on supplements boxes that code is also generated by the software. By intering each persons to study, Based on the generated sequence, Supplementary box that code has been registered on that, will allocate to the person.
Blinding (investigator's opinion)
Double blinded
Blinding description
For the purpose of concealment in the randomization process, individual codes will be used on supplements boxes that code is also generated by the software. This study is a two-blind study in which participants, principal investigator and health care personnel are keeping blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Iran University of Medical Science
Street address
Iran University of Medical Science, Next to Milad tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-12-10, 1398/09/19
Ethics committee reference number
IR.IUMS.REC.1398.193

Health conditions studied

1

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

Primary outcomes

1

Description
serum malondialdehyde
Timepoint
Before intervention and 3 months after intervention
Method of measurement
colorimetric method

2

Description
glutathione peroxidase
Timepoint
Before intervention and 3 months after intervention
Method of measurement
colorimetric method

3

Description
superoxide dismutase
Timepoint
Before intervention and 3 months after intervention
Method of measurement
colorimetric method

4

Description
total antioxidant capacity
Timepoint
Before intervention and 3 months after intervention
Method of measurement
elisa method

5

Description
uric acid
Timepoint
Before intervention and 3 months after intervention
Method of measurement
turbiditymetery method

Secondary outcomes

1

Description
Dietry intake
Timepoint
Before intervention and 3 months after intervention
Method of measurement
24-hour questionnaire food intake for 3 days and analysis with N4 software

2

Description
Anthropometric indices
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Meters, scales and computing

3

Description
Physical activity
Timepoint
Before intervention and 3 months after intervention
Method of measurement
International Physical Activity Questionnaire

Intervention groups

1

Description
Control group: Patients referring to Akbar Abadi Hospital who are willing to cooperate and have inclusion criteria will recieve starch. They will use 3 gram Starch from Golha factory ( 3 capsules of 1 gram) for 3 months.
Category
Placebo

2

Description
Intervention group: Patients referring to Akbar Abadi Hospital who are willing to cooperate, have inclusion criteria. and receive sumac powder. They will consume 3 gram sumac making by the Golha factory ( 3 capsules of 1 gram) for 3 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Akbar Abadi Hospital
Full name of responsible person
Dr maryam Kashanian
Street address
Shahid Akbar Abadi Hospital, Baghe Ferdows station, Molavi street
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Fax
Email
maryamkashanian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevallian
Street address
Iran University of Medical Science, Next to Milad tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
n-aryaeian@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research deputy of Iran University of Medical Science
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
Iran University of Medical Sciences
Full name of responsible person
Dr Naheed Aryaeian
Position
Faculty member(Associate professor)
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition group, School of health, Iran University Of Medical Science, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4750
Fax
+98 21 8862 2707
Email
n-aryaeian@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Naheed Aryaeian
Position
Faculty member(Associate professor)
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition group, School of health, Iran University Of Medical Science, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4750
Fax
+98 21 8862 2707
Email
n-aryaeian@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Naheed Aryaeian
Position
Faculty member(Associate professor)
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition group, School of health, Iran University Of Medical Science, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4750
Fax
+98 21 8862 2707
Email
aryaeian.n@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the questionnaires includes demographic information, 24-hour recall, physical activity, as well as clinical and biochemical outcomes after unidentifiable individuals will be publish.
When the data will become available and for how long
The start of access period is from 1399 solar year equivalent to 2020 A.D
To whom data/document is available
All individuals, including researchers who working in university and scientific places, physicians, nutritionists and those engaged in the industry, can use these documentations.
Under which criteria data/document could be used
Use of the documentation is permitted if there is no copyng and no citation or inappropriate citation.
From where data/document is obtainable
Dr Nahid Aryaeian
What processes are involved for a request to access data/document
If the journal is free, the documents is availabe at the scientific search bases. Otherwise will need to pay money.
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