Saffron - Adults
Study: The Effects of a Saffron Extract on Menopausal Symptoms in Women during Perimenopause: A Randomised, Double-Blind, Placebo-Controlled Study 12-week, parallel-group, double-blind, randomised controlled trial 86 female participants.
What was the study about?
Researchers wanted to find out if saffron extract (affron®) could help improve menopausal symptoms, especially mood-related ones, in perimenopausal women (those going through the transition to menopause).
How the study worked:
- 86 women were randomly given either:
- A saffron supplement (14 mg, twice daily)
- Or a placebo (dummy pill)
- The study lasted 12 weeks.
- Participants completed questionnaires about their mood, menopause symptoms, and quality of life.
What did they find?
- Women taking saffron showed greater improvements in mood than those on a placebo.
- Anxiety reduced by 33%
- Depression reduced by 32%
- Saffron also helped lower negative emotions overall.
Was it safe?
Yes. No major side effects were reported, and the saffron was well tolerated.
Study: Comparison of petal of Crocus sativus L. and fluoxetine in the treatment of depressed outpatients: a pilot DB RCT by Akhondzadeh Basti A et al, 2007RCT Randomised placebo controlled— Double Blind— 40 Human participants— P value: <0.0001.
What was the study about?
Researchers wanted to see if saffron petals (from the same plant that gives us saffron spice) could work as well as fluoxetine (Prozac) in treating mild to moderate depression.
How was the study done?
- 40 adults with diagnosed major depression took part.
- They were split into two groups:
- One group took saffron petal extract (15 mg, twice a day)
- The other took fluoxetine (10 mg, twice a day)
- The study lasted 8 weeks.
- Doctors measured depression symptoms using a common scale (HAM-D).
What did they find?
- Both treatments worked equally well.
- Around 25% of people in each group saw their symptoms fully go into remission.
- No major side effects were noted in either group.
What does this mean?
Saffron petals might be a natural, well-tolerated alternative to antidepressants like fluoxetine, especially for people with mild to moderate depression who don’t want to deal with typical medication side effects.
Study: Crocin, the main active saffron constituent, as an adjunctive treatment in major depressive disorder: RCT, DB, pilot clinical trial by Talaei A et al, 2014— RCT Randomised placebo controlled— Double Blind— 40 Human participants— P value: <0.0001.
What was this study about?
Researchers tested whether crocin, a key active compound in saffron, could help reduce depression and anxiety when added to standard antidepressant treatment.
How was it done?
- 40 adults with major depressive disorder took part.
- All were already taking a standard SSRI (like fluoxetine, sertraline, or citalopram).
- Participants were split into two groups:
- One group received crocin tablets (30 mg/day) alongside their SSRI.
- The other group received placebo tablets alongside their SSRI.
- The trial lasted 4 weeks.
- Depression, anxiety, and general well-being were tracked using validated questionnaires.
What did they find?
After 4 weeks:
- The crocin group improved significantly more than the placebo group.
Average symptom score reductions:
Depression (BDI):
- Crocin: ↓17.6 points
- Placebo: ↓6.15 points
Anxiety (BAI):
- Crocin: ↓12.7 points
- Placebo: ↓2.6 points
General health (GHQ):
- Crocin: ↓17.2 points
- Placebo: ↓10.3 points
Conclusion
Crocin enhanced the effectiveness of antidepressants, significantly reducing depression, anxiety, and improving overall wellbeing in just 4 weeks. It may be a promising natural add-on therapy for people with depression.
Study: A DB, RCT and placebo-controlled trial of Saffron (Crocus sativus L.) in the treatment of anxiety and depression by Mazidi M et al, 2016— RCT Randomised placebo controlled— Double Blind— 60 Human participants— P value: <0.001.
Background
Depression and anxiety are common mental health disorders often treated with drugs that can have serious side effects. Herbal alternatives like saffron are being explored for safer treatments.
Study Design
- 60 adults with anxiety and depression participated.
- Randomised, double-blind, placebo-controlled trial lasting 12 weeks.
- Participants took either 50 mg saffron capsules or a placebo twice daily.
- Symptoms were measured using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI) at baseline, 6 weeks, and 12 weeks.
Results
- 54 participants completed the study.
- Saffron significantly reduced both depression and anxiety scores compared to placebo after 12 weeks (p < 0.001).
- Side effects were rare.
Conclusion
Saffron supplementation shows a significant positive effect on anxiety and depression symptoms with minimal side effects, supporting its potential as a natural treatment option.
Study: Efficacy of Crocus sativus (saffron) in treatment of major depressive disorder associated with post-menopausal hot flashes: a double-blind, randomized, placebo-controlled trial— RCT Randomised placebo controlled— Double Blind— 60 Human participants— P value: <0.001.
Why the study was done:
Many women going through menopause experience hot flashes and mood problems like depression. Hormone therapy can help, but it has some unwanted side effects. So, researchers wanted to see if saffron, a natural herb, could safely help with both hot flashes and depression without those side effects.
What they did:
They took 60 women who had hot flashes after menopause and gave half of them saffron pills and the other half fake pills (placebo) for 6 weeks. They checked how bad their hot flashes were and how depressed they felt before and during the study.
What they found:
56 women finished the study. Those who took saffron had a clear improvement in both their hot flashes and mood compared to the placebo group. The number of side effects was about the same in both groups, meaning saffron was safe.
What this means:
Saffron looks like a safe and effective natural option to help women reduce hot flashes and depression symptoms after menopause, without the risks that come with hormone treatments.
Study: An investigation into an evening intake of a saffron extract on sleep quality, cortisol, and melatonin concentrations in adults with poor sleep: A randomised, double-blind, placebo-controlled, multi-dose study. Lopresti AL, Smith SJ, Drummond PD (published 14 Jan 2022)— RCT Randomised placebo controlled— Double Blind— 102 Human participants— P value: <0.001.
What the study wanted to find out:
The researchers wanted to confirm whether taking saffron can help adults who don’t sleep well.
What they did:
They ran a 28-day study with 120 adults who had poor sleep. The participants were split into three groups: one took a fake pill (placebo), one took 14 mg of saffron, and one took 28 mg of saffron each night before bed. They measured sleep quality, mood, insomnia symptoms, and certain hormones related to sleep.
What they found:
People who took saffron reported better sleep quality, felt better in the morning, and had fewer insomnia symptoms compared to those taking the placebo. Both saffron doses worked similarly well. Saffron also increased melatonin levels (a hormone that helps regulate sleep) but didn’t change cortisol (a stress hormone). No significant side effects were reported.
What it means:
Taking saffron for 28 days can improve sleep quality in adults who have trouble sleeping. More studies are needed to check how well saffron works over a longer time and to understand exactly how it helps with sleep.
Study: Saffron for treatment of fluoxetine-induced sexual dysfunction in women: randomised double-blind placebo-controlled study Ladan Kashani et al. 2012
What the study wanted to find out:
The researchers wanted to see if saffron can help women who are experiencing sexual problems caused by the antidepressant fluoxetine.
What they did:
They conducted a 4-week study with 38 women who had depression and were taking fluoxetine. The women were randomly given either saffron capsules (30 mg per day) or a placebo. Their sexual function was measured at the start, after 2 weeks, and after 4 weeks.
What they found:
By the end of the study, women taking saffron showed significant improvements in overall sexual function, especially in areas like arousal, lubrication, and pain during sex. However, there was no significant change in sexual desire, satisfaction, or orgasm. Side effects were similar in both the saffron and placebo groups.
What it means:
Saffron may be a safe and helpful option to improve some sexual problems in women taking fluoxetine, particularly in aspects like arousal and discomfort.
Saffron - Children
Study: Crocus sativus L. Versus Methylphenidate in Treatment of Children with Attention-Deficit/Hyperactivity Disorder: A Randomised, Double-Blind Pilot Study. RCT Randomised, double-blind, parallel-group, 54 children aged 6–17 years with ADHD.
What it’s about:
ADHD is commonly treated with stimulant medicines like methylphenidate, but these can have side effects or may not be tolerated by all children. Researchers wanted to test whether saffron capsules, a natural extract with mood-balancing and neuroprotective properties, could be as effective as methylphenidate for managing ADHD symptoms.
What they did:
54 children were randomly assigned to receive either:
- Saffron extract (20–30 mg/day, depending on weight)
- Methylphenidate (20–30 mg/day)
The study lasted 6 weeks. Symptom changes were measured using standard parent and teacher ADHD rating scales.
What they found:
Saffron was as effective as methylphenidate in reducing both inattentive and hyperactive-impulsive symptoms. The degree of improvement was similar between the groups, and side effects were mild and comparable.
What it means:
Saffron extract may be a safe and effective alternative to stimulant medicines for children with ADHD, though larger and longer studies are needed to confirm.
Study: Effectivity of Saffron Extract on Children and Adolescents with ADHD: A Randomised Clinical Trial by López-Hernández J et al, 2022.
RCT Open-label, comparative trial, 72 children/adolescents aged 7–17 with ADHD.
What it’s about:
Not all children respond equally to stimulant medications, and some families seek natural alternatives. This study compared a saffron extract (Saffr’Activ) with methylphenidate in children and adolescents with ADHD to see how the treatments differed in effects on inattention and hyperactivity.
What they did:
72 participants were allocated to receive either:
- Saffron extract (30 mg/day)
- Methylphenidate (average therapeutic dose)
Treatment lasted 12 weeks. ADHD symptoms were measured with both clinical tests and parent/teacher reports.
What they found:
Overall efficacy was similar between groups. Saffron appeared more effective in reducing hyperactivity symptoms, whereas methylphenidate was slightly stronger for inattentive symptoms. Safety and tolerability were good in both groups.
What it means:
Saffron could be a useful natural option for ADHD management, particularly for hyperactivity. It may also appeal to families seeking alternatives to stimulants or concerned about side effects.
Study: Saffron Extract Kozanis, Metformin, and Placebo for Weight Management in Obese Prediabetic Adolescents: A Randomised, Double-Blind, Placebo-Controlled Trial by Stagiannis KD et al, 2023.
RCT Randomised, double-blind, three-arm trial, 80 obese prediabetic adolescents.
What it’s about:
Obesity and prediabetes in adolescence increase the risk of type 2 diabetes and heart disease later in life. Metformin is often prescribed, but researchers explored whether saffron extract could provide similar benefits as a natural supplement for weight and metabolic health.
What they did:
80 obese adolescents with pre-diabetes were randomised into 3 groups:
- Saffron extract capsules (dose equivalent to 30 mg/day crocin)
- Metformin (standard therapeutic dose)
- The Placebo
Treatment lasted 12 weeks. Researchers measured body mass index (BMI z-score), waist circumference, lipid profile, and glucose metabolism.
What they found:
Saffron supplementation significantly reduced BMI z-score, waist circumference, and LDL cholesterol compared to placebo. The metabolic benefits were not as strong as metformin, but saffron still showed a clear advantage over placebo. No serious adverse events were reported.
What it means:
Saffron may be a promising natural aid for weight management and metabolic health in adolescents with obesity and pre-diabetes, with a favourable safety profile.
