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The Effect of Fennel Supplements and Water Exercises on Esterogen Levels and some Metabolic Parameters in Diabetic Menopausal Women

Protocol summary

Study aim
The study of the effect of fennel supplements and exercise on estrogen and insulin levels and glucose and lipid profiles and physical signs of menopause in women with type 2 diabetes پیشنهاد ویرایش درباره ‏‫مترجم Google‬انجمنتلفن همراه درباره Googleحریم خصوصی و شرایطراهنما
Design
The controlled clinical trials, community based and action-oriente parallel group,tree-blind, randomized,
Settings and conduct
Shahroud University of Technology
Participants/Inclusion and exclusion criteria
Female gender, history of type 2 diabetes, according to doctor's diagnosis, medical records, at least one year and no more than 5 years of menopause, no history of cardiovascular disease, and non-use of herbal remedies or complementary medicine, no use Sedation or anti-depressant drugs, no drug addiction or smoking, insulin use and no complications of diabetes, including diabetic foot ulcers, menopause, and post-menopausal hormone therapy
Intervention groups
Exercise and placebo group, Supplemental group, Supplement and exercise group, Placebo group. Consumption: Soft FENNELIN capsule containing 100 mg of active ingredient in fennel and dumplings, the manufacture of Barij Essence, will be used in capsules of the same name labeled with R and H twice a day plus breakfast and dinner.
Main outcome variables
Insulin serum levels, Estrogen levels and level of serum glucose in postmenopausal women with type 2 diabetes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180709040404N1
Registration date: 2019-01-08, 1397/10/18
Registration timing: prospective

Last update: 2019-01-08, 1397/10/18
Update count: 0
Registration date
2019-01-08, 1397/10/18
Registrant information
Name
Shahrbanoo Rabiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3223 0457
Email address
Sh.rabiei@shahroodut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-15, 1397/10/25
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Fennel Supplements and Water Exercises on Esterogen Levels and some Metabolic Parameters in Diabetic Menopausal Women
Public title
The impact of fennel and Aquatic supplement on menopausal symptoms and diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes who are postmenopausal women with menopausal symptoms
Exclusion criteria:
Age
From 50 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants and researchers and data analyst have been blinded to drugs and drugs
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences
Street address
Shahrood University of Technology, University Boulevard, Shahrood
City
shahrood
Province
Semnan
Postal code
3619995161
Approval date
2018-05-23, 1397/03/02
Ethics committee reference number
IR.SHMU.REC.1397.380

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Estrogen levels in postmenopausal women with type 2 diabetes after 8 weeks of exercise in water and supplementation with fennel.
Timepoint
To measure the research variables, blood sampling is performed one day before the beginning of the training period, with 12 hours of fasting and 48 hours after the last session of the exercise.
Method of measurement
A blood sample of 5 centimeters of anti-cubital vein per person will be sitting in rest and resting. After 8 weeks of training in water, with fennel supplementation, the amount of estrogen, insulin and glucose will be measured. To determine estrogen levels, the radioimmune method (RIA) and the human estradiol kit will be used.

2

Description
Insulin serum levels in postmenopausal women with type 2 diabetes after 8 weeks of exercise in water and supplementation with fennel.
Timepoint
To measure the research variables, blood sampling is performed one day before the beginning of the training period, with 12 hours of fasting and 48 hours after the last session of the exercise.
Method of measurement
A blood sample of 5 centimeters of anti-cubital vein per person will be sitting in rest and resting. After 8 weeks of training in water, with fennel supplementation, the amount of estrogen, insulin and glucose will be measured. To measure insulin from methods A laboratory routine will be used

3

Description
The level of serum glucose in postmenopausal women with type 2 diabetes after 8 weeks of exercise in water and supplementation with fennel
Timepoint
To measure the research variables, blood sampling is performed one day before the beginning of the training period, with 12 hours of fasting and 48 hours after the last session of the exercise.
Method of measurement
A blood sample of 5 centimeters of anti-cubital vein per person will be sitting in rest and resting. After 8 weeks of training in water, with fennel supplementation, the amount of estrogen, insulin and glucose will be measured.To measure glucose from methods A laboratory routine will be used

Secondary outcomes

1

Description
Lipid Profile (Includes Cholesterol, Triglyceride, HDL.LDL), Type 2 Methicillic-Type Postmenopausal Women. Study of Menopausal Symptoms of Type 2 Diabetic Women
Timepoint
To determine the level of lipid profile, blood transfusion is performed one day before the beginning of the exercise, with 12 hours of fasting and 48 hours after the last training session. Filling in the questionnaire for physical symptoms of menopause includes 11 questions (MRS) one day before the beginning of the exercise and 48 hours after the last training session
Method of measurement
In order to determine the lipid profile, blood sampling at 8:10 am to 5 centimeters of anticyclical vein from each patient will be performed in sitting position. A laboratory routine test will be used to measure serum lipid concentrations. For examination of the physical symptoms Menopause The MRS questionnaire will include 11 questions

Intervention groups

1

Description
First intervention group: water treatment group and fennel supplementation. Consumption: Soft FENNELIN capsule containing 100 mg effective ingredient in fennel and placebo, manufactured by «Barij Essence» , as capsules of the same name as R and H twice daily, plus breakfast and dinner. Will be consumed.
Category
Treatment - Other

2

Description
Second intervention group: Group exercise in water and placebo.
Category
Treatment - Other

3

Description
Third intervention group: Fennel supplement group. Consumption: Soft FENNELIN capsule containing 100 mg effective ingredient in fennel and placebo, manufactured by «Barij Essence» , as capsules of the same name as R and H twice daily, plus breakfast and dinner. Will be consumed.
Category
Treatment - Other

4

Description
Control group: Group of placebo or comparison group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center of Azima Shahrud
Full name of responsible person
Dr Ehsan Binesh
Street address
Ferdowsi street
City
Shahrood
Province
Semnan
Postal code
3616713543
Phone
+98 23 3222 2065
Fax
+98 23 3222 2065
Email
sh.rabiei1357@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Dr Ali Hassani
Street address
7th Square
City
shahrood
Province
Semnan
Postal code
3616713432
Phone
+98 23 3445 5645
Fax
+98 23 3445 5646
Email
sh.rabiei@shahroodut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrood University of Technology
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
Shahroud University of Technology
Full name of responsible person
Dِr Ali Hassani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
7th Square
City
Shahrood
Province
Semnan
Postal code
3614513654
Phone
+98 232233208
Fax
Email
sh.rabiei@shahroodut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Dr Ali Hassani
Position
Assossiate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
7th Square
City
Shahrood
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
sh.rabiei@shahroodut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Technology
Full name of responsible person
Shahrbanoo Rabiei
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiology of Exercise
Street address
Shahrood University of Technology, Shahrood blvd, Shahrood.
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
+98 23 3239 2209
Email
sh.rabiei@shahroodut.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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Effectiveness of fennel supplements and water exercises on menopausal symptoms and diabetes mellitus in diabetic menopause
When the data will become available and for how long
8 months after the intervention
To whom data/document is available
Researchers working in academic and academic institutions
Under which criteria data/document could be used
Academic research
From where data/document is obtainable
Sharbanoo Rabiei
What processes are involved for a request to access data/document
Contact by email: sh.rabiei1357@gmail.com Review and answer up to a week
Comments
does not have
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