Effect of Curcumin as Nutraceutical in Patients of Depression
NCT ID: NCT01022632
Last Updated: 2010-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2009-03-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fluoxetine
Fluoxetine : 20 mg Once a day in morning after taking food for 6 weeks
Fluoxetine
Fluoxetine ; 20 mg Once a day in morning after taking food for 6 weeks
Curcumin
Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks
Curcumin
Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks
Curcumin and Fluoxetine
Curcumin 500 12 hourly after taking food in morning and evening and Fluoxetine 20 mg Once a day in morning after taking food for 6 weeks
Curcumin and Fluoxetine
Curcumin 500 12 hourly after taking food in morning and evening and Fluoxetine 20 mg Once a day in morning after taking food for 6 weeks
Interventions
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Curcumin
Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks
Fluoxetine
Fluoxetine ; 20 mg Once a day in morning after taking food for 6 weeks
Curcumin and Fluoxetine
Curcumin 500 12 hourly after taking food in morning and evening and Fluoxetine 20 mg Once a day in morning after taking food for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* Score greater than 7 but less then 35 on the 17-item Hamilton Depression (HAM-D) Scale at screening.
* The patient has relative(s) to care for him/her
* Informed consent obtained from the patient or relative
Exclusion Criteria
* Current suicidal or homicidal risk, as determined by the investigator.
* Clinically significant liver disease (such as hepatitis, cirrhosis, etc); or clinically significant elevation of liver enzyme tests (two times the upper limit of normal.
* History of seizure disorder (other than febrile).
* Patient who has had monoamine oxidase inhibitor , any selective serotonin reuptake inhibitor or any other antidepressant in last 15 days
* Any of the following DSM-IV diagnoses current (within past 3 months) schizophrenia, schizo-affective, or other psychotic disorder; bipolar disorder; current panic disorder or obsessive compulsive disorder; history of psychotic features of affective disorder (mood congruent or incongruent)
* Patient with history of untreated or unstable thyroid disorder
* Failed to respond to at least two adequate antidepressant trials (defined as 6 weeks or more treatment with either greater than or equal to 150 mg imipramine, or tricyclic equivalent), or greater than or equal to 60 mg of phenelzine, or MAOI equivalent, or greater than or equal to 100 mg of sertraline, or its SSRI equivalent.
* Have had other investigational drugs within 30 days or other psychotropic medication within 21 days.
* Known allergy or hypersensitivity to the study medications.
* Receiving psychotherapies which are specifically designed to treat depression, eg, interpersonal psychotherapy during the study period.
* Mental retardation or cognitive impairment, or any disorder that might interfere with their ability to give consent or follow study procedures and requirements.
* In case of female patients, Abstinence or effective method of contraception throughout the study
18 Years
65 Years
ALL
No
Sponsors
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Health and Family Welfare Department, Government of Gujarat, India
UNKNOWN
Arjuna Natural Extracts Ltd.
INDUSTRY
Government Medical College, Bhavnagar
OTHER
Responsible Party
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Government Medical College, Bhavnagar-364001, Gujarat, India
Principal Investigators
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Dr. Bharat Panchal, MD
Role: PRINCIPAL_INVESTIGATOR
Professor and Head, Department of Psychiatry, Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India
Locations
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Sir Takthasinhji General Hospital
Bhavnagar, Gujarat, India
Countries
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Other Identifiers
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Pharmacol no.01 /2008 Research
Identifier Type: -
Identifier Source: org_study_id