Schizophrenic patients are at greater risk of premature death which is mostly due to cardio vascular diseases. A major risk factor for cardiovascular accidents is metabolic syndrome . Metabolic syndrome frequency is about 30% in schizophrenic patients that is due to a basic change in body metabolism of this group or as a major side effect of neuroleptic drugs. Up to now studies failed to introduce a single ingredient for treatment of metabolic syndrome in this population that is both effective on all the aspects of this disorder( hyper-lipidemia, hyper-glycemia, high blood pressure, central obesity) and does not worsen patients psychiatric symptoms either. After studying previous reviews on the efficacy of herbal medicine on metabolic syndrome and lack of previous reports on considerable psychiatric side effects of these ingredients. We considered a double blind Randomized controlled Trial evaluating the efficacy of Celery, Dill, and Green tea on the metabolic syndrome in 60 chronic schizophrenic patients who were admitted in one of the wards of Razi psychiatry hospital. patients must have been stable for the last two month and the need for change in patients medication would exclude them from the trial. Patients were categorized into two ‘case’ and ‘control’ groups. We evaluated patients’ weight, waist circumference, BP, TG, FBS, and HDL as variables indicator of metabolic syndrome prior to intervention and in 3 interval,Also patients were evaluated for side effects during the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102915206N1
Registration date:2014-02-24, 1392/12/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-24, 1392/12/05
Registrant information
Name
Emytis Tavakoli
Name of organization / entity
University of social welfare and rehabilitation sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0050
Email address
em.tavakoli@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of social welfare and rehabilitation sciences
Expected recruitment start date
2013-06-26, 1392/04/05
Expected recruitment end date
2013-09-27, 1392/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing theraputic effects of celery, dill and green tea combination with placebo in treatment of metabolic syndrome in patients with schizophrenia
Public title
theraputic effects of celery, dill and green tea combination in treatment of metabolic syndrome in patients with schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of schizophrenia and metabolic syndrome; age between 18 and 65 years; female; agreement of patient and her guardian towards participation in the trial. Exclusion criteria: any change in the schizophrenia medication within two months prior to the trial; coexistence of another major mental disorder; any hyper sensitive reaction to the medication; exacerbation of mental symptoms.
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
university of welfare and rehabilitation sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Postal code
1985713834
Approval date
2013-06-10, 1392/03/20
Ethics committee reference number
8392
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Weist circumference
Timepoint
3 months
Method of measurement
By a regular meter,cm
2
Description
Blood pressure
Timepoint
3 months
Method of measurement
Pressure guage,mmHg
3
Description
Fasting blood sugar
Timepoint
3 months
Method of measurement
md/ml, evaluation of venous blood sample by spectrophotometer
4
Description
HDL(high density lipoprotein)
Timepoint
3 months
Method of measurement
mg/ml, evaluation of venous blood sample by spectrophotometer
5
Description
TG(triglycerides)
Timepoint
3 months
Method of measurement
mg/ml, evaluation of venous blood sample by spectrophotometer
Secondary outcomes
1
Description
Gastrointestinal dyscomfort
Timepoint
3 months after intervention
Method of measurement
Personal interview
Intervention groups
1
Description
Intervention group: prescription of tablet composed of extracts of celery, dill, and green tea three times a day half an hour before meal for 3 consecutive months.
Category
Treatment - Drugs
2
Description
Control group: prescription of a tablet with identical appearance to the herbal combination tablet three times a day half an hour before meal for 3 consecutive months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi mental hospital
Full name of responsible person
Street address
City
Shahr e Rey
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mrs Cheraghi
Street address
Kkodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Emytis Tavakoli
Position
Psychiatry resident
Other areas of specialty/work
Street address
Shahid Rastegari Blvd. Razi mental hospital
City
Shahr-E-Rey
Postal code
Phone
+98 21 3340 1604
Fax
Email
tavakoli79@yahoo.com; em.tavakoli@uswr.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Emytis Tavakoli
Position
Psychiatry resident
Other areas of specialty/work
Street address
Shahid Rastegari blvd. Razi mental hospital
City
Shahr -e- Rey
Postal code
569 - 18735
Phone
+98 21 3340 1604
Fax
Email
tavakoli79@yahoo.com; em.tavakoli@uswr.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Emytis Tavakoli
Position
psychiatry resident
Other areas of specialty/work
Street address
Razi mental hospital,Aminabad
City
Shahr e rey
Postal code
56918735
Phone
+98 21 3340 1604
Fax
Email
em.tavakoli@uswr.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)