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IRCT20140804018677N20 IRCT 2022-05-17 Shahid Beheshti University of Medical Sciences Effect of ginseng in reducing the severity of fatigue in individuals with idiopathic chronic fatigue Assessing the effect of ginseng in reducing the severity of fatigue in individuals with idiopathic chronic fatigue 2022-05-05 anticipated 80 Complete https://irct.ir/trial/63105 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will have equal chance to be assigned to studied groups. We will use random digits table to make random sequence. After determining the first number, we will continue downward and allocate even numbers to cases and odd numbers to placebo. As in small sample sizes, it would be probable that one group be completed earlier, if one group completed earlier, we will allocate the other assigned numbers to other group. A person out of study group will put her figure on one digit of the table with closed eyes and according to assumed agreement will go downward through the table and write the numbers down until completing the sample size in each group. Code "A" will allocated to even numbers and considered as "intervention group" and code "B" will allocated to odd numbers and considered as "placebo group". At the end we will have the sequence of 80 specific numbers and A&B codes. A person out of study team will put the numbers in sealed packets till the time of sampling, Blinding description: It is a double blind study. A third person out of study team have the sequence of codes that provide the team with sealed pockets containing allocation code (supplement and placebo) at the time of sampling. The following groups of people: participants, research team including principle investigator, data collectors, and outcome assessors will be blind. 1-2 Chronic fatigue. Intervention 1: Intervention group: 500 mg Ruginseng (Ghaem Daro) capsule two times daily for 4 weeks. Intervention 2: Control group: Placebo contain maltodextrine, 500 mg, (Ghaem darou company), two times daily for 4 weeks. Yes - There is a plan to make this available What will be shared: All data would be available to public When: Starting 6 months after publication To whom: To all Conditions: No other criteria Where to obtain: Email to soodehrazeghi@gmail.com How to obtain: Sending email Comments:
public Soodeh Razghei Jahromi
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
Tehran Iran (Islamic Republic of) 193954741 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences scientific Soodeh Razghei Jahromi
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
Tehran Iran (Islamic Republic of) 193954741 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 18-65 years Willing to participate in the study Having chronic idiopathic fatigue based on internist diagnosis 18 years 65 years Both Pregnancy and lactation Having diabetes Having known cardiovascular disease Having known renal disease Having any types of cancer R53.82 Chronic fatigue, unspecified Treatment - Other Placebo Intervention group: 500 mg Ruginseng (Ghaem Daro) capsule two times daily for 4 weeks Control group: Placebo contain maltodextrine, 500 mg, (Ghaem darou company), two times daily for 4 weeks Fatigue severity. Timepoint: Before and after 4 weeks of intervention. Method of measurement: fatigue severity scale (FSS) questionnaire. Shahid Beheshti University of Medical Sciences Approved 2022-02-27 Ethics committee of Shahid Beheshti medical university No. 46, West Arghavan St., Farahzadi Blv., Qods Town Tehran Tehran Iran (Islamic Republic of)