Perimenopausal DisorderNCT06227858
Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated With Perimenopause in Healthy Women
A study testing Safr'Inside supplement (Activ'Inside, SAS) and Plcebo in people with Perimenopausal Disorder, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
Trial summary
The aim of the present study is to assess the effects of a normalised saffron extract supplementation, which is an extract of the flower Crocus sativus, on perimenopausal symptoms. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopausal Disorder
- What is being tested?
- Safr'Inside supplement (Activ'Inside, SAS) and Plcebo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Aug 2025to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Biological Female which identify themselves as Women
- Aged ≥ 40 years
- Irregular menstrual cycle for at least 3 months
- Presenting typical symptoms of perimenopause with GCS score over 20
- BMI range between 18-35 kg/m2
- Healthy woman
Who cannot join
- Less than 40 years old
- Pregnant
- Diagnosed with diseases related to reproductive system such as PCOS or endometriosis
- Taking anti-depressant medication or sleeping pills
- Taking hormonal replacement therapy (HRT)
- Taking conventional drug treatment or dietary supplementation
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- Having medical history or medical/surgical event in the last 6 months, or has been treated for cancer or any other ongoing treatment for the past 3 months,
- Current and/or past history of hyper/hypotension, CVD, diabetes, autoimmune diseases, musculoskeletal disorder or endocrine or immunocompromised or neurological or psychological disorders,
- Being medicated for these conditions,
- History of allergic reactions to saffron intake,
- Decisionally challenged subjects or unable to comply to the study
- Any conditions that could contraindicates the use of saffron
- Currently smoking or ceased smoking in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Psychological and Physiological Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated to Perimenopause in Healthy Older Women: A Randomised Double-blind, Placebo-Controlled, Parallel-group Clinical Trial
The aim of the present study is to assess the effects of a normalised saffron extract supplementation, which is an extract of the flower Crocus sativus, on perimenopausal symptoms.
Read the detailed description
After being informed about the study protocol aim and potential risks, healthy volunteer woman (walk-in outpatients) will undergo a pre-screening to determine eligibility for study entry. At the visit 1, patients who meet the pre-screening criteria will undergo a second screening to confirm their eligibility based on inclusion and exclusion criteria. After signing the inform consent form, patient who meet eligibility criteria will be randomised in a double-blind manner (participants and investigators) in a 1:1 ratio to saffron extract supplementation (15mg, twice daily) or matched placebo (twice daily) for a period of 3-months (12 weeks).
- Conditions
- Perimenopausal Disorder
- Being tested
- Safr'Inside supplement (Activ'Inside, SAS), Plcebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safr'Inside supplement (Activ'Inside, SAS)Dietary supplement
Dietary supplementation will be taken in addition to habitual diet of the patients
PlceboOther
Placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron)
| Study group | Role | What they receive |
|---|---|---|
| Saffron extract supplementation (15mg, twice daily) | Experimental | The experimental group will take a single capsule containing: 15mg of of saffron extract (stigma of the flower Crocus sativus), 340mg of Maltodextrin, encapsulated in hydroxypropyl methyl cellulose (HPMC), twice daily (one morning and one evening after the meal). Receives: Dietary Supplement: Safr'Inside supplement (Activ'Inside, SAS) |
| Control group | Placebo comparator | The Control group will take a single placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron) twice daily (one morning and one evening after the meal). Receives: Other: Plcebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on overall perimenopause clinical symptoms severity
Changes in Greene Climacteric Scale (GCS) score
Measured: 6-weeks, 12-weeks
Secondary outcomes (8)
Effect on sleep quality
Changes in Pittsburg sleep quality index (PSQI) score
Measured: 6-weeks, 12-weeks
Effect on mood
Changes in Profile of Mood State (POMS) score
Measured: 6-weeks, 12-weeks
Effect on quality of life
Changes in Short Form Health Survey (SF-36) score
Measured: 6-weeks, 12-weeks
Exploratory measures
Changes in fasting plasma glucose level
Measured: 12-weeks
Exploratory measures
Changes in gut microbiome (16S RNA Seq)
Measured: 12-weeks
Exploratory measures
Changes in FSH levels
Measured: 12-weeks
Exploratory measures
Changes in LH levels
Measured: 12-weeks
Exploratory measures
Changes in TSH levels
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start20 Aug 2025
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimenopausal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 x 2 factorial design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia, Activ'inside
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227858
- Sponsor's protocol ID
- LUMHS/REC/-221
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Psychological and Physiological Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated to Perimenopause in Healthy Older Women: A Randomised Double-blind, Placebo-Controlled, Parallel-group Clinical Trial
- ClinicalTrials.gov ID
- NCT06227858
- Acronym / sponsor ID
- LUMHS/REC/-221
- Conditions
- Perimenopausal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- University of East Anglia, Activ'inside
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to assess the effects of a normalised saffron extract supplementation, which is an extract of the flower Crocus sativus, on perimenopausal symptoms.
Detailed description
After being informed about the study protocol aim and potential risks, healthy volunteer woman (walk-in outpatients) will undergo a pre-screening to determine eligibility for study entry. At the visit 1, patients who meet the pre-screening criteria will undergo a second screening to confirm their eligibility based on inclusion and exclusion criteria. After signing the inform consent form, patient who meet eligibility criteria will be randomised in a double-blind manner (participants and investigators) in a 1:1 ratio to saffron extract supplementation (15mg, twice daily) or matched placebo (twice daily) for a period of 3-months (12 weeks).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 x 2 factorial design
| Arm | Type | Receives |
|---|---|---|
| Saffron extract supplementation (15mg, twice daily) | Experimental | Dietary Supplement: Safr'Inside supplement (Activ'Inside, SAS)The experimental group will take a single capsule containing: 15mg of of saffron extract (stigma of the flower Crocus sativus), 340mg of Maltodextrin, encapsulated in hydroxypropyl methyl cellulose (HPMC), twice daily (one morning and one evening after the meal). |
| Control group | Placebo comparator | Other: PlceboThe Control group will take a single placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron) twice daily (one morning and one evening after the meal). |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Biological Female which identify themselves as Women
- Aged ≥ 40 years
- Irregular menstrual cycle for at least 3 months
- Presenting typical symptoms of perimenopause with GCS score over 20
- BMI range between 18-35 kg/m2
Key exclusion criteria (13 listed)
- Less than 40 years old
- Pregnant
- Diagnosed with diseases related to reproductive system such as PCOS or endometriosis
- Taking anti-depressant medication or sleeping pills
- Taking hormonal replacement therapy (HRT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safr'Inside supplement (Activ'Inside, SAS)Dietary supplementation will be taken in addition to habitual diet of the patients | Dietary supplement | Saffron extract supplementation (15mg, twice daily) |
| PlceboPlacebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron) | Other | Control group |
Primary outcome
Effect on overall perimenopause clinical symptoms severity
Time frame: 6-weeks, 12-weeks
Changes in Greene Climacteric Scale (GCS) score
8 secondary outcomes
Effect on sleep quality
Time frame: 6-weeks, 12-weeks
Effect on mood
Time frame: 6-weeks, 12-weeks
Effect on quality of life
Time frame: 6-weeks, 12-weeks
Exploratory measures
Time frame: 12-weeks
Exploratory measures
Time frame: 12-weeks
Exploratory measures
Time frame: 12-weeks
Exploratory measures
Time frame: 12-weeks
Exploratory measures
Time frame: 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safr'Inside supplement (Activ'Inside, SAS) and Plcebo in people with Perimenopausal Disorder, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on overall perimenopause clinical symptoms severity (time frame: 6-weeks, 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.