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A Comparison of Effect of Aerobic Exercise with Saffron Pills on CRP levels and Quality of Life in Fibromyalgia Patients

Protocol summary

Study aim
Determining the Effects of Aerobic Exercise and Saffron Consumption on CRP and Quality of Life in Fibromyalgia Patients
Design
Clinical trial with control group, with factorial groups, randomized, phase 3 on 32 patients.
Settings and conduct
The research method is quasi-experimental with pretest-post test design.Population of this study consisted of women with the age of25-50 years with fibromyalgia referring to Imam Khomeini Hospital in Sari.The placebo and Saffron are placed inside the capsule in exactly the same way, participants and researchers will not be aware of the type of medication received. Finally, study hypotheses in the study groups were examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being infected to Fibromyalgia ,Lack of Metabolic Diseases , Menopause ,Do not consume energetic substances such as: Vitamins ,Dietary Supplements, Herbs Exclusion criteria:Consumption Cigarettes and Alcoholic beverages ,Having Regular Exercise ,Consumption history Antidepressants
Intervention groups
1- Aerobic training group-Placebo, 2-Drug Intervention Group, 3-Drug-exercise group (Combined), 4- Control group( placebo) Aerobic exercise for six weeks (three sessions per week) consisted of 60-70% of maximal heart rate training for 24 to 39 minutes, under the control of a physician. The intervention time for all 4 groups were 6 weeks. The Drug group and the Drug-exercise group took 30 mg once daily for 6 weeks. The aerobic-placebo and control group took a placebo capsule (30 mg of starch) prepared by Green Plants Company once a day for 6 weeks according to the doctor's instructions.
Main outcome variables
Measuring resting heart rate Measuring the waist to hip ratio

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191125045496N2
Registration date: 2021-01-16, 1399/10/27
Registration timing: retrospective

Last update: 2021-01-16, 1399/10/27
Update count: 0
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
Mostafa Behzad Khamslo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3310 9230
Email address
mostafabehzadkh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2019-10-23, 1398/08/01
Trial completion date
2020-11-21, 1399/09/01
Scientific title
A Comparison of Effect of Aerobic Exercise with Saffron Pills on CRP levels and Quality of Life in Fibromyalgia Patients
Public title
Evaluation of the Effect of Aerobic Exercise and Saffron Consumption in Fibromyalgia Patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Being infected to Fibromyalgia Lack of Metabolic Diseases, Menopause Do not consume energetic substances such as: Vitamins, Dietary Supplements, Herbs
Exclusion criteria:
Consumption Cigarettes and Alcoholic beverages Having Regular Exercise Consumption history Antidepressants
Age
From 25 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 48
Actual sample size reached: 32
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random method was used to determine the sample of each group. First, the names of all patients who entered the study were obtained, assigned to each of the numerical patients, and then a lottery was conducted between them.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
No. 3, Mahyar St., Maulam Blvd., Sari Town
City
Sari
Province
Mazandaran
Postal code
4817875816
Approval date
2019-12-18, 1398/09/27
Ethics committee reference number
IR.MAZUMS.REC.1398.1166

Health conditions studied

1

Description of health condition studied
Fibromyalgia
ICD-10 code
H35.17
ICD-10 code description
fibromyalgia

Primary outcomes

1

Description
Quality of Life
Timepoint
At baseline (before intervention) and 6 weeks after intervention
Method of measurement
Short Form Quality of Life Questionnaire (SF-36)

2

Description
C-reactive-protein
Timepoint
At baseline (before intervention) and 6 weeks after intervention
Method of measurement
By Eliza's research kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Aerobic exercise-placebo group:Aerobic exercise for six weeks (three sessions per week) consisted of 60-70% of maximal heart rate training for 24 to 39 minutes, under the control of a physician.In addition to training, the group took a placebo capsule (30 mg of starch) prepared by Green Plants Company once a day for 6 weeks according to the doctor's instructions.
Category
Treatment - Other

2

Description
Intervention group: Drug Intervention Group:In this group of safrotin capsules containing standardized dry extract of saffron, made by Green Plants Company, 30 mg once a day was prescribed according to the doctor's instructions for 6 weeks.
Category
Treatment - Other

3

Description
Intervention group: Drug-exercise group (Combined):In addition to aerobic exercise for six weeks (three sessions per week), this group includes exercise with an intensity of 60 to 70% of maximum heart rate for 24 to 39 minutes per session, from Safrotin capsule containing standardized dry extract of saffron, made by Green Plants Company ,Received 30 mg once daily during the intervention as directed by the treating physician.
Category
Treatment - Other

4

Description
Control group: Control group: This group took a placebo capsule (30 mg of starch) prepared by Green Plants Company once a day for 6 weeks according to the doctor's instructions.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Sari
Full name of responsible person
Mehri Behzad Khamslo
Street address
Imam Khomeini Hospital., Amir Boulevard., Sari Town
City
Sari
Province
Mazandaran
Postal code
4817875816
Phone
+98 11 3310 9231
Email
mehribehzadkh@gamil.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Seyed Hamzeh
Street address
Imam Khomeini Hospital., Amir Mazandaran St., Sari Town
City
Sari
Province
Mazandaran
Postal code
4817875816
Phone
+98 11 3310 9230
Email
hosseinish20@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
5
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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Hamzeh Hosseini
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
mam Khomeini Hospital., Amir Mazandaran St., Sari Town
City
Sari
Province
Mazandaran
Postal code
4817875816
Phone
+98 11 3310 9231
Email
hosseinish20@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mostafa Behzad Khamslo
Position
Teaching
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 3, Mahyar St., Maulam Blvd., Sari Town
City
Sari
Province
Mazandaran
Postal code
4817875816
Phone
+98 11 3310 9230
Email
mostafabehzadkh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mostafa Behzad Khamslo
Position
Teaching
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 3, Mahyar St., Maulam Blvd., Sari Town
City
Sari
Province
Mazandaran
Postal code
4817875816
Phone
+98 11 3310 9230
Email
mostafabehzadkh@yahoo.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
No - There is not 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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