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Saffron and Alzheimer

Saffron extract in the treatment of mild to moderate Alzheimer’s disease: A double blind randomized controlled trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT138711051556N1
Enrollment
50
Registered
2009-02-12
Start date
2006-11-10
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

Mild to moderate Alzheimer. Dementia in Alzheimer's disease

Interventions

Intervention 1: Intervention: Capsule of Saffron 30 mg/day. Intervention 2: Control: Tab Donepezil 10 mg/day.
Treatment - Drugs
Intervention: Capsule of Saffron 30 mg/day
Control: Tab Donepezil 10 mg/day

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: A diagnosis of probable Alzheimer’s disease according to the criteria of National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA); Presence of mild to moderate dementia [score of = 12 on the cognitive subscale of Alzheimer’s Disease Assessment Scale (ADAS-cog) and = 2 on Clinical Dementia Rating Scale (CDR)]. Exclusion Criteria: Concomitant diseases such as hypertension, congestive heart failure, non-insulin dependent diabetes mellitus and hypothyroidism; Patients with evidence of other neurodegenerative disorders; Any cardiovascular disease likely to prevent completion of the study; Clinically significant psychiatric diseases; Urinary outflow obstruction; Active peptic ulcer; Any history of epilepsy; Significant drug or alcohol misuse; Drugs with anticholinergic effects or cholinomimetic effects.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of Alzheimer. Timepoint: Every month. Method of measurement: ADAS-cog.

Secondary

MeasureTime frame
Severity of Alzheimer. Timepoint: Every Month. Method of measurement: CDR-SB.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Apr 2, 2026