Evaluation of the effect of ginger as an adjunct therapy along with SSRIs to reduce anxiety inpatients with Generalized Anxiety Disorder (GAD)

Determining the adjuvant effects of ginger capsules on the reduction of generalized anxiety disorder in concomitant use of SSRIs compared with placebo, which means in comparison with the reduction of generalized anxiety disorder in patients taking SSRIs and starch capsules

This study is a phase 2 3 clinical trial with eighty participants. Forty patients in intervention group: SSRI drug with specific dose + two capsules of 500 mg of ginger per day Forty patients in control group: SSRI drug with specific dose + two starch capsules per day For randomization, we will use the method of foursome Block Randomization. (Two intervention sheets and two control sheets and random selection between these four sheets for each patient until the completion of four sheets then repeating this procedure)

This study is a randomized clinical trial which will be performed on patients with generalized anxiety disorder referred to the psychiatric clinic of Sina Hospital or a psychiatrist's private office within 12 weeks (while taking given SSRI drug with ginger or starch). The patients will be blinded whether they are taking ginger or placebo beside the SSRI drug

Diagnosis of generalized anxiety disorder by the physician and the patient's informed consent to participate in the study, the participants being in the age group of 18 to 65 years old and not having an accompanying disease, and also the participants should not be pregnant or breastfeeding

Eighty patients with generalized anxiety disorder with study criteria are randomly divided into two intervention or control groups, the first group is given SSRI drug and ginger rhizome powder capsules and the group Second, we give SSRIs and placebo capsules

The severity and extent of recovery from anxiety according to Hamilton Anxiety Rating Scale

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.

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.