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Evaluation of the effect of Saffron Aqueous Extract and its active constitute crocin on prevention of metabolic syndrome in people with schizophrenia on olanzapin treatment

Protocol summary

Summary
The objective of this study is to assess the efficacy and safety of administration of Saffron aqueous extract (SAE) and its active constitute crocin for 12 week in patients with schizophrenia. This study will be undertaken in Razi Psychiatry Hospital, Tehran, Iran. Male inpatients with schizophrenia aged between 18-65, without prior history of metabolic syndrome or using any herbal treatment or special food diet will be treated with olanzapine 5-20 mg per day. After 4 to 6 weeks, in maintenance phase of treatment, they will be randomized to receive either Capsule of SAE (30 mg/day) or crocin (30 mg/day) or placebo with the same shape beside olanzapine. The main efficacy measures are: change in Metabolic Syndrome Criteria. The Metabolic Syndrome will be evaluated in week 6 and 12;Fasting blood glucose, serum lipids will be assessed at the baseline and will be repeated in weeks 2, 6 and 12. Waist circumference and blood pressure would be assessed at the baseline and will be repeated in weeks 6 and 12. Fasting blood level of insulin and HgbA1c would be measured at baseline and week12. while complete blood test, TFT, RFT, LFT would be checked at baseline and in weeks 2, 6 and 12 for assessment of side effects. In addition, general satisfaction of treatment,and any unwanted side effects like GI disturbances or abnormal bleeding or hypersensitivity will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013020312351N1
Registration date: 2013-03-27, 1392/01/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-03-27, 1392/01/07
Registrant information
Name
Seiedeh Bentolhoda Mousavi
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3340 1220
Email address
be.mousavi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2013-03-05, 1391/12/15
Expected recruitment end date
2013-10-07, 1392/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Saffron Aqueous Extract and its active constitute crocin on prevention of metabolic syndrome in people with schizophrenia on olanzapin treatment
Public title
saffron and metabolic syndrome, general, positive, negative an cognitive symptomes in schizophrenic patients treated with olanzapin.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:diagnosis of schizophrenia according to DSM-IV-TR criteria; clinical stability without acute phase; no acute medical problem; no coronary heart disease or metabolic syndrome; no neurological disease; no substance abuse or dependency accept nicotine; no usage of anti platelets drugs or ASA or herbal medicines; not being mental retarded; no special slimming or obesity diets Exclusion criteria: Any unwanted side effects that interfere with standard treatment or cause patient refusal of treatment; Need to change olanzapine in the course of treatment for any reason
Age
From 18 years old to 65 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
Koodakyar Ave, Daneshjoo Blvd, Evin.
City
Tehran
Postal code
1985713834
Approval date
2012-12-24, 1391/10/04
Ethics committee reference number
25128 / 2 / آ / 801 /91

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

Primary outcomes

1

Description
Metabolic Syndrome Parameters (FBS, TGL,HDL, BP, Waist circumstance)
Timepoint
weeks 2,6,12
Method of measurement
Blood Sample Test and Physical Examination

Secondary outcomes

1

Description
Changes in Insuline Resistance, General, Positive and Negative and Cognitive Symptomes
Timepoint
Insuline Resistence: week 0 and 12, others weeks 0, 6 and 12
Method of measurement
HOMA-IR, BPRS, MMSE.

Intervention groups

1

Description
Intervention group 1: Olanzapin, 5 mg oral Tablets, 1 to 4 times per day for 4 mounts Aqua Extract of saffron, 15 mg oral Capsules,2 times per day for 3 mounts
Category
Treatment - Drugs

2

Description
Intervention group 2: Olanzapin, 5 mg oral Tablets, 1 to 4 times per day for 4 mounts placebo, capsules with the same shape, 2 times per day for 3 mounts
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Psychiatry Hospital
Full name of responsible person
Dr. Farbod Fadai
Street address
Amin Abad St. Shahre Rey
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr. Farbod Fadai
Street address
Koodakyar Ave. Daneshjoo 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
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

2

Sponsor
Name of organization / entity
Added at 2013-08-19: Tarbiat Modares University
Full name of responsible person
Added at 2013-08-19: Dr.S.Zahra Bathai
Street address
Added at 2013-08-19: Jalale Ale Ahmad
City
Added at 2013-08-19: Tehran
Grant name
بروزرسانی 1392/5/28:
Grant code / Reference number
Added at 2013-08-19:
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Added at 2013-08-19: Tarbiat Modares University
Proportion provided by this source
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
Dr. Seyedeh Bentolhoda Mousavi
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Koodakyar Ave, Daneshjoo Blvd, Evin
City
Tehran
Postal code
1985713834
Phone
+98 212218008392
Fax
+98 21 3340 1604
Email
be.mousavi@uswr.ac.irb_mousavi@ymail.com
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
Dr. Farbod Fadai
Position
Associated Professor of Psychiaty, Geriatric Fellowship
Other areas of specialty/work
Street address
Koodakyar Ave, Daneshjoo Blvd, Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0140
Fax
+98 21 3340 1604
Email
farbodfadai@uswr.ac.irfarbodfadai@gmail.com
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
Dr. Seyedeh Bentolhoda Mousavi
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Koodakyar Ave. Daneshjo Blvd. Evin
City
Tehran
Postal code
1985713834
Phone
+98 212218008392
Fax
+98 21 3340 1604
Email
be.mousavi@uswr.ac.irb_mousavi@ymail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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