Saffron Vs duloxetine in the treatment of Fibromyalgia

Saffron Vs doluxetine in the treatment of Fibromyalgia: a randomized , double blind controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201604261556N91

Enrollment

Registered

2016-07-26

Start date

2016-08-22

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

Fibromyalgia. Fibromyalgia

Interventions

Intervention 1: Intervention group 1: capsule Duloxetine 30 mg paer day in the first week and then 30 mg BID for 7 weeks. Intervention 2: Intervention group 2: capsule saffron 15 mg per day in the fir

Treatment - Drugs

Intervention group 1: capsule Duloxetine 30 mg paer day in the first week and then 30 mg BID for 7 weeks

Intervention group 2: capsule saffron 15 mg per day in the first week and then 15 mg BID for 7 weeks

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: age at least 18 years old; meeting ACR criteria for Fibromyalgia; severity of pain at least 40 based on visual analogue scale. Exclusion criteria: receiving Duloxetine at present or in the past; any psychiatric disorder except for MDD; osteoarthritis, multiple sclerosis; history of multiple surgeries, infectious disease, uncontrolled endocine disease, hepatic disease, cardiovascular disease, AIDS, epilepsy, malignancy; pregnancy; nursing women; receiving serotonergic agents or MAOIs; active suicidal thoughts; abuse of alcohol or substances in the previous two years; receiving anticonvulsants, muscle relaxants, opioids, steroids, benzodiazepines in the last week; receiving thioridazine.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Severity of pain. Timepoint: Baseline and weeks: 2, 4, 6 and 8 after beginig of the treatment. Method of measurement: Breif Pain Index(BPI).;Severity of fatigue. Timepoint: Baseline and weeks: 2, 4, 6 and 8 after beginig of the treatment. Method of measurement: Global Fatigue Index.;Severity of fibromyalgia symptoms. Timepoint: Baseline and weeks: 2, 4, 6 and 8 after beginig of the treatment. Method of measurement: Fibromyalgia Impact Questionnaire(FIQ).	—

Measure

Time frame

Severity of pain. Timepoint: Baseline and weeks: 2, 4, 6 and 8 after beginig of the treatment. Method of measurement: Breif Pain Index(BPI).;Severity of fatigue. Timepoint: Baseline and weeks: 2, 4, 6 and 8 after beginig of the treatment. Method of measurement: Global Fatigue Index.;Severity of fibromyalgia symptoms. Timepoint: Baseline and weeks: 2, 4, 6 and 8 after beginig of the treatment. Method of measurement: Fibromyalgia Impact Questionnaire(FIQ).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactProf. Shahin Akhondzadeh

Tehran University of Medical Sciences

s.akhond@sina.tums.ac.ir+98 21 5541 2222

Outcome results

None listed

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