saffron and metabolic syndrome, general, positive, negative an cognitive symptomes in schizophrenic patients treated with olanzapin.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013020312351N1

Enrollment

Registered

2013-03-27

Start date

2013-03-05

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia. Schizophrenia

Interventions

Intervention 1: 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. Intervention 2: Inter

Treatment - Drugs

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

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

Eligibility

Sex/Gender

Male

Age

18 Years to 65 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Metabolic Syndrome Parameters (FBS, TGL,HDL, BP, Waist circumstance). Timepoint: weeks 2,6,12. Method of measurement: Blood Sample Test and Physical Examination.	—

Secondary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Seyedeh Bentolhoda Mousavi

University of Social Welfare and Rehabilitation Sciences

be.mousavi@uswr.ac.irb_mousavi@ymail.com+98 212218008392

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026