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Comparison between the effectiveness of Crocus sativus and Crocin in the treatment of patients with major postpartum depression under common medical care.

Investigation into the effectiveness of Crocus savitus and its active ingredient Crocin as a complementary approach in the treatment of patients with major postpartum depression receiving treatment, using triple blind random clinical trial controlled with placebo, plus assessment of the change in patients' Beck II score.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130826014477N5
Enrollment
45
Registered
2018-08-01
Start date
2018-08-06
Completion date
Unknown
Last updated
2018-09-11

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

Conditions

major postpartum depression. Severe mental and behavioural disorders associated with the puerperium, not elsewhere classified Puerperal psychosis NO

Interventions

Intervention 1: Control group: Using placebo alongside the patient's main drug regimen. Intervention 2: Second intervention group: Tablets containing five mg Crocin (prepared in the Pharmacy faculty o

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Nursing mothers after their delivery up to the passage of six months Nursing mothers in the 18-50 age range Delivery of full-term, healthy, singleton baby Acceptance of completion of the informed consent form after providing the necessary information on the investigation Obtaining of an exact diagnosis of the major depressive disorder using Edinburgh questionnaire by a psychiatrist during a clinical examination

Exclusion criteria

Exclusion criteria: Patients with a history of chronic, systemic diseases Patients with a history of medical disorders such as preeclampsia and diabetes Patients allergic to saffron Smoking cigarettes, drinking alcohol and taking drugs Patients with a history hepatic and renal disorders

Design outcomes

Primary

MeasureTime frame
Change in mean score of BDI-II. Timepoint: Every two weeks for12 weeks. Method of measurement: BDI_II Questionnaire.

Secondary

MeasureTime frame
Monitor of, investigation into and finding evidence for completing probable adverse effects of using Corcus Sativus and Crocin in nursing mothers to add to drug's information in herbal pharmacopeia. Timepoint: Beginning of intervention and end of every months during patient's visit for a period of twelve weeks. Method of measurement: Observation and clinical examination of the patient.;Examining patients' response to the alternative medicine. Timepoint: At the end of intervention. Method of measurement: Assessment of patients' number with fifty percent decrease in average score Beck II questionnaire in comparison with the base line.;Examining patient's remission under treatment. Timepoint: The end of intervention. Method of measurement: Assessment of patients' number with seventy percent decrease in average score Beck II questionnaire in comparison with the base line.;Assessment of the effects of such interfering factors as age, treatment protocol, type of delivery and etc. Timepoint: The end of intervention. Method of measurement: Statistical analysis of collected data with SPSS software.;Investigation on alternative medicine on females' sexual function. Timepoint: Beginning of intervention and end of every months. Method of measurement: FSFI Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZhila Taherzadeh

Mashhad University of Medical Sciences

taherzadehzh@mums.ac.ir+98 51 1882 3255

Outcome results

None listed

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