]>
IRCT20201108049306N1 IRCT 2021-01-29 Hamedan University of Medical Sciences Evaluation of ginger as an adjunct therapy in Generalized Anxiety Disorder Evaluation of the effect of ginger as an adjunct therapy along with SSRIs to reduce anxiety inpatients with Generalized Anxiety Disorder (GAD) 2021-03-05 anticipated 80 Complete https://irct.ir/trial/53072 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of block randomization with individual units by preparing four sheets of paper. On the two sheets we write the letter "I" meaning "Intervention" and on the other two sheets we write the letter "P" meaning "Placebo". Mix the sheets together and place them in the desk drawer. With the referral of each eligible patient, one of the sheets is randomly pulled out and based on this sheet whether it is "I" or "P", they will be assigned to one of the two intervention or control groups, Blinding description: Patients are blinded that they are taking ginger or starch capsules and all of them are told they are taking ginger capsules along with the prescribed SSRI. The researcher is also blind to whether patients are receiving ginger or not (Only the doctor or clinical caregiver is not blinded). The method of blinding is that the doctor who has four sheets in his desk drawer (two "i" sheets that means "Intervention" and two "p" sheets that means "Placebo") by referring to each of the eligible patients, one of the sheets Randomly taken out and based on this sheet, I or P, will be assigned to one of the two intervention or control groups, and the doctor will record that each patient belongs to intervention group or placebo group. It should be noted that the pulled out sheets will not be returned to the drawer until all four sheets have been pulled out. After accidentally pulling out all four sheets, all the sheets are returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size is reached. 2-3 Generalized Anxiety Disorder (GAD). Intervention 1: Forty people in intervention group: Patients under treatment with SSRI at a specific dose (Sertraline oral tablets at the dose of 25 mg once daily and may be increased to 100 mg daily, or Citalopram 10 mg oral tablets once daily and may be increased to 40 mg daily) for 12 weeks + two 500 mg ginger capsules per day for 12 weeks Patients' visits may last from 20 minutes to an hour long of doctor's visit and questions and answers (filling out questionnaires) by the researcher. These visits will occur at the time of diagnosis, two weeks later, and also 4, 8, and 12 weeks after the first visit and diagnosis of GAD. Intervention 2: Control group: Patients under treatment with SSRI at a specific dose (Sertraline oral tablets at the dose of 25 mg once daily and may be increased to 100 mg daily, or Citalopram oral tablets 10 mg once daily and may be increased to 40 mg daily) for 12 weeks + two starch capsules per day (placebo) for 12 weeks Patients' visits may last from 20 minutes to an hour long of doctor's visit and questions and answers (filling out questionnaires) by the researcher. These visits will occur at the time of diagnosis, two weeks later, and also 4, 8, and 12 weeks after the first visit and diagnosis of GAD. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I need to talk more about this with my professors, there is no more information
public Sara Ataei
School of Pharmacy, Hamadan University of Medical Science, Shahid Fahmideh Blvd., Hamadan
Hamedan Iran (Islamic Republic of) 6517838678 +98 81 3838 1591 s.ataei@umsha.ac.ir Hamedan University of Medical Sciences scientific Sara Ataei
School of Pharmacy, Hamadan University of Medical Science, Shahid Fahmideh Blvd., Hamadan
Hamedan Iran (Islamic Republic of) 6517838678 +98 81 3838 1591 s.ataei@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of Generalized Anxiety Disorder by a physician based on the Hamilton Anxiety Rating Scale The patient has filled in the consent form and consciously enters the study and cooperates Age group 18 to 65 years old 18 years 65 years Both The patient is pregnant or breastfeeding The patient has a major co-morbid psychological disorder (including depressive disorder, bipolar disorder, psychosis, and drug use) The patient has taken any antioxidant medication or supplement in the past month Taking medicine that has interaction with ginger The patient has co-morbid disease (other than neurological diseases) F41.1 Generalized anxiety disorder Treatment - Drugs Placebo Forty people in intervention group: Patients under treatment with SSRI at a specific dose (Sertraline oral tablets at the dose of 25 mg once daily and may be increased to 100 mg daily, or Citalopram 10 mg oral tablets once daily and may be increased to 40 mg daily) for 12 weeks + two 500 mg ginger capsules per day for 12 weeks Patients' visits may last from 20 minutes to an hour long of doctor's visit and questions and answers (filling out questionnaires) by the researcher. These visits will occur at the time of diagnosis, two weeks later, and also 4, 8, and 12 weeks after the first visit and diagnosis of GAD. Control group: Patients under treatment with SSRI at a specific dose (Sertraline oral tablets at the dose of 25 mg once daily and may be increased to 100 mg daily, or Citalopram oral tablets 10 mg once daily and may be increased to 40 mg daily) for 12 weeks + two starch capsules per day (placebo) for 12 weeks Patients' visits may last from 20 minutes to an hour long of doctor's visit and questions and answers (filling out questionnaires) by the researcher. These visits will occur at the time of diagnosis, two weeks later, and also 4, 8, and 12 weeks after the first visit and diagnosis of GAD. Score of anxiety based on the Hamilton Anxiety Rating Scale. Timepoint: Measurement of severity and extent of improvement of anxiety at the beginning of the study (before the intervention) and 14, 28, 56 and 84 days after the start of use. Method of measurement: Hamilton Anxiety Rating Scale. Hamedan University of Medical Sciences Approved 2020-11-07 Ethics committee of Hamedan University of Medical Sciences Research Ethics Committees, Vice Chancellor for Research and Technology, Hamedan University of Medical Sciences Hamedan Hamadan Iran (Islamic Republic of)