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Saffron stigma in women with no major postpartum depression

Evaluation of the antidepressant effect of saffron stigma in women with postpartum depression

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015121714477N2
Enrollment
56
Registered
2016-02-11
Start date
2016-01-21
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

postpartum depression. Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified

Interventions

Intervention 1: The patients in Intervention group will orally receive tablet of saffron 30 ml /day (BD) for 8 weeks. Intervention 2: Control group will orally receive placebo tablet that looks quite
Treatment - Drugs
Placebo
The patients in Intervention group will orally receive tablet of saffron 30 ml /day (BD) for 8 weeks.
Control group will orally receive placebo tablet that looks quite similar to saffron tablets. Only the code written on the containers are different from each other. Frequency and duration of using pl

Sponsors

Mashhad university of medical sciences? Vice chancellor for research
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Subjects for this study will meet the following criteria: Age 18 to 40 years; A history of at least two weeks with postpartum-related mood disturbances of mild or moderates, and self-report of the onset of depression within three months of a normal vaginal delivery or uncomplicated Caesarean section; A current episode of no major depression (meeting 3-4 criterion symptoms determined by clinical interview). Additionally, to ensure that subjects meet a minimum threshold for severity of depression, subjects will have scores greater than or equal to 11 on the Beck Depression Inventory (BDI-II). During at least two clinic visits during the screening phase; Not greater than six months post delivery; In good medical health, and not taking any medication or dietary and herbal supplements on a regular basis (with the exception of multivitamins or calcium supplements). Subjects will be excluded if they meet any of the following criteria: Severe major depression with postpartum psychosis, suicidal ideation or anyone requiring immediate treatment after clinical assessment; Current treatment with antidepressant medications or prior hormonal therapy for the treatment of postpartum-related mood or physical symptoms within the last six months; History of psychiatric illness during the two years before the reported onset of the current episode of depression or a history of either mania or postpartum psychosis at any time in the past; History of anticoagulant therapy; Renal disease; Patients with a known hypersensitivity of saffron.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The mean decrease in BDI-II score. Timepoint: weeks 0,4,8. Method of measurement: self-rating BDI-II scales.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSobhani Farzaneh

Mashhad University of Medical Sciences

SobhaniF891@mums.ac.ir+98 51 3882 3255

Outcome results

None listed

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