Investigating the effect of zedoary medicinal plant (Curcuma zedoaria) on the fatigue of soldiers in military training course in Shiraz: a randomized double blind placebo-controlled clinical trial
Determination of fatigue in the intervention group before the study
Determination of fatigue in the intervention group after the study
Determination of fatigue in the placebo group before the study
Determination of fatigue in the placebo group after the study
Comparison of fatigue between the intervention and placebo groups before the study
Comparison of fatigue between the intervention and placebo groups after the study
Design
A hundred of soldiers will randomly be selected from a garrison and divided into two 50 person groups of intervention and placebo. As for the randomization, The method of permutation blocks with 25 quadruple blocks will be used .
Settings and conduct
In the intervention group, each person will receive 2 capsules of zedoary powder (500 mg) per day for 15 days. In contrary, subjects in the placebo group will receive placebo capsules contain 500 mg of starch powder with a completely similar appearance twice a day for 15 days.
The capsules of drug and placebo have the same size, color, and smell; thus, the trial will be double blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Training soldiers living in military garrison in Shiraz; Lack of chronic diseases; Signing the informed consent Exclusion criteria: Sensitivity to zedoary
Intervention groups
In the intervention group, each person will receive two 500 mg capsules of zedoary powder per day for 15 days.
In the control group, each person will receive two 500 mg capsules of starch powder per day for 15 days.
Main outcome variables
Score of Multidimensional Fatigue Inventory questionnare
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130216012486N3
Registration date:2018-01-01, 1396/10/11
Registration timing:prospective
Last update:2018-01-01, 1396/10/11
Update count:0
Registration date
2018-01-01, 1396/10/11
Registrant information
Name
Babak Daneshfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 8867
Email address
daneshfard@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of zedoary medicinal plant (Curcuma zedoaria) on the fatigue of soldiers in military training course in Shiraz: a randomized double blind placebo-controlled clinical trial
Public title
Effect of zedoary on fatigue
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Training soldiers living in military barracks in Shiraz
Lack of chronic diseases
Signing the informed consent
Exclusion criteria:
Sensitivity to zedoary
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization using statistical software will be done. The capsules of the drug and the placebo have the same size, color, and smell; thus neither soldiers nor the researcher will know the allocation and the trial will be conducted double blind.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the soldiers and the researcher will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
Shahid Fatemi St., Col. Etemadzadeh St., AJA University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14185/611
Approval date
2017-11-29, 1396/09/08
Ethics committee reference number
IR.AJAUMS.REC.1396.84
Health conditions studied
1
Description of health condition studied
Relationship of the zedoary medicinal plant with the fatigue of soldiers in military training course
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score of Multidimensional Fatigue Inventory questionnare
Timepoint
At the beginning of the study and 15 after the start of taking the capsule
Method of measurement
Multidimensional Fatigue Inventory questionnare
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
2
Description
Control group:
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Military Education Garrison
Full name of responsible person
Babak Daneshfard
Street address
Zand St., Setad Sq., Shiraz Medical School
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3234 5145
Fax
+98 71 3234 5145
Email
babakdaneshfard@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Babak Daneshfard
Street address
Zand St., Setad Sq., Shiraz Medical School, Shiraz, Iran