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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: IRCT
Last refreshed on: 22 February 2018
Main ID:  IRCT2015052622416N1
Date of registration: 2016-08-15
Prospective Registration: No
Primary sponsor: Vice chancellor for research of Islamic Azad University, Science and Research
Public title: Effect of one section strenuous physical activity & Crocus stavus Supplementation on HSP 70 , IL-6, TNF a in male mountain climbers
Scientific title: Effect of one section strenuous physical activity & Crocus stavus Supplementation on HSP 70 , IL-6, TNF a in male mountain climbers
Date of first enrolment: 2015-11-06
Target sample size: 11
Recruitment status: Complete
URL:  http://en.irct.ir/trial/19336
Study type:  interventional
Study design:  Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.  
Phase:  N/A
Countries of recruitment
Iran (Islamic Republic of)
Contacts
Name: Fatemeh Jan Bozorgi   
Address:  Islamic Azad University, Science and Research, Boulevard of Martyrs HESARAK, University Square, the martyr Stari highway, Tehran 1477893855 Tehran Iran (Islamic Republic of)
Telephone: +98 214486517982
Email: Fattima25jb@gmail.com
Affiliation:  Islamic Azad University, Science and Research
Name: Farshad Gazalian   
Address:  Islamic Azad University, Science and Research, Boulevard of Martyrs HESARAK, University Square, the martyr Stari highway, Tehran 1477893855 Tehran Iran (Islamic Republic of)
Telephone: +98 214486517982
Email: Phdghazalian@gmail.com
Affiliation:  Islamic Azad University, Science and Research
Key inclusion & exclusion criteria
Inclusion criteria: Inclusion criteria : with minimum 2 years mountaineering ; Climbing experience at minimum height of 4000 meter ; A minimum height of 3500 m bivouac; who were not smoking; No overweight ;No history of endocrine diseases;No diabetes;No heart disease and chronic disease
exclusion criteria : Endocrine diseases ; Diabetes; Heart disease and any disease
lack of taking the supplements for any reason; Failure to observe the test conditions such as altitude sports

Exclusion criteria:

Age minimum: 27 years
Age maximum: 37 years
Gender: Male
Health Condition(s) or Problem(s) studied
Z00.6,Z00
Effect of one section strenuous physical activity & Crocus stavus Supplementation.
Examination for normal comparison and control in clinical research programme
Examination for normal comparison and control in clinical research programme
Intervention(s)
Saffron supplementation; dose of 300 mg per day; once per day; for 10 days.
Saffron supplementation; dose of 300 mg per day; once per day; for 10 days
Primary Outcome(s)
TNFa. Timepoint: Before Saffron supplementation: Before physical activity , Immediately after physical activity , 1 hour post-physical activity - After supplementation Saffron : Before physical activity , Immediately after physical activity , 1 hour after physical activity. Method of measurement: Using blood, serum TNFa value in Picograms per deciliter by Kit.
IL-6. Timepoint: Before Saffron supplementation: Before physical activity , Immediately after physical activity , 1 hour post-physical activity - After supplementation Saffron : Before physical activity , Immediately after physical activity , 1 hour after physical activity. Method of measurement: Using blood, serum IL-6 value in Picograms per deciliter by Kit.
Hsp 70. Timepoint: Before Saffron supplementation: Before physical activity , Immediately after physical activity , 1 hour post-physical activity - After supplementation Saffron : Before physical activity , Immediately after physical activity , 1 hour after physical activity. Method of measurement: Using blood, serum Hsp70 value in Nanograms per deciliter by Kit.
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Vice chancellor for research of Islamic Azad University, Science and Research
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Committee Ethics in biomedical research Science and Research Branch of Islamic Azad University
Results
Results available:
Date Posted:
Date Completed:
URL:
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