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Clinical anxiolytic effect of Sitadi Agada and Imipramine (TCAs) in the management of Generalized Anxiety Disorders

Phase 2
Conditions
Health Condition 1: F411- Generalized anxiety disorder
Registration Number
CTRI/2022/10/046915
Lead Sponsor
I
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

a)Patient willing to sign the consent form.

b)Patients of either sex with age between 18 to 60 years.

c)Patient fulfilling the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM â?? IV).

e)Patient who score at least 14 on the Hamilton Anxiety Rating Scale (HARSâ?? A) at baseline visit.

Exclusion Criteria

a)Patient who suffers Anxiety due to direct physiological effect of a substance (e.g. alcohol etc) or a general medical condition (e.g. Hyperthyroidism).

b)Occurrence of anxiety exclusively during mood disorder, a psychotic disorder or a pervasive development disorder.

c)Patients having history of chronic diseases like Diabetes Mellitus, Ischemic Disease, Dyslipidemia, Hypertension, Malignancies, Chronic Renal Failure,

Any Endochrinological disorders etc. will be excluded.

d)Patients who have completed participation in any other clinical trial during the past six months.

e)Pregnant or lactating women.

f)Any other condition which the investigator thinks may jeopardize the study.

g)Patients receiving Anxiolytic Drugs will be excluded.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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