General Anxiety DisorderLEONORUSNCT06954038
Evaluate the Beneficial Effects of an Oral Nutritional Supplement Based on Leonurus Cardiaca for the Improvement of Mood and Anxiety
A study testing Leonurus cardiaca extract 250 mg and Leonurus cardiaca extract 500 mg in people with General Anxiety Disorder, run by Azienda di Servizi alla Persona di Pavia.
Trial summary
This study aims to evaluate the efficacy and safety of Leonurus cardiaca extract in reducing anxiety symptoms in adults with Generalized Anxiety Disorder (GAD). Sixty drug-free participants aged 20-50 years with a diagnosis of GAD will be randomly assigned to receive either Leonurus cardiaca extract or placebo for 30… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- General Anxiety Disorder
- What is being tested?
- Leonurus cardiaca extract 250 mg and Leonurus cardiaca extract 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 20 to 50 years
- Diagnosis of a generalised anxiety disorder (GAD), with manifestations occurring for >= 6 months that include excessive worry, poor concentration, restlessness, muscle tension, irritability, fatigue and difficulty sleeping
Who cannot join
- Women who are pregnant or breastfeeding
- Use of hormonal contraceptives in the last 3 months
- Current diagnosis of major psychiatric disorders (e.g., major depressive disorder, severe anxiety disorders, schizophrenia, bipolar disorder)
- Known endocrine disorders (e.g., hypothyroidism, hyperthyroidism, diabetes)
- Use of medications that could affect mood or the menstrual cycle (e.g., SSRIs, anxiolytics, antipsychotics)
- Severe hepatic or renal impairment
- Any other serious or unstable medical condition that, in the investigator's judgment, could interfere with study participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double Dummy, Placebo-controlled Pilot Study to Evaluate the Beneficial Effects of an Oral Nutritional Supplement Based on Leonurus Cardiaca for the Improvement of Mood and Anxiety
This study aims to evaluate the efficacy and safety of Leonurus cardiaca extract in reducing anxiety symptoms in adults with Generalized Anxiety Disorder (GAD). Sixty drug-free participants aged 20-50 years with a diagnosis of GAD will be randomly assigned to receive either Leonurus cardiaca extract or placebo for 30 days. The primary outcome is the reduction in anxiety symptoms assessed by the SCAG scale. Secondary outcomes include changes in quality of life (SF-12), perceived stress (PSQ), anxiety severity (HAM-A), and anthropometric measures. Safety will be assessed through liver, kidney, and thyroid function tests. Assessments will be conducted at baseline, day 14, and day 30.
- Conditions
- General Anxiety Disorder
- Being tested
- Leonurus cardiaca extract 250 mg, Placebo, Leonurus cardiaca extract 500 mg
- Keywords
- Leonurus cardiaca, Herbal extract, Anxiety, SCAG scale, Herbal remedy for GAD, HAM-A, PSQ, SF-12
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leonurus cardiaca extract 250 mgDietary supplement
Participants will receive a dietary supplement containing 250 mg of Leonurus cardiaca extract formulated in phospholipids. The supplement is administered as a single oral capsule, once daily in the morning, for 30 consecutive days.
PlaceboDietary supplement
Participants will receive a placebo capsule identical in appearance to the active supplement, administered twice daily for 30 consecutive days.
Leonurus cardiaca extract 500 mgDietary supplement
Participants will receive a dietary supplement containing 500 mg of Leonurus cardiaca extract formulated in phospholipids. The supplement is administered as a single oral capsule, once daily in the morning, for 30 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Leonurus 250 mg | Experimental | Participants in this arm will receive a standardized oral supplement containing 250 mg of Leonurus cardiaca formulated in phospholipids, taken once daily in the morning for 30 days. Receives: Dietary Supplement: Leonurus cardiaca extract 250 mg |
| Placebo | Placebo comparator | Participants in this arm will receive a placebo identical in appearance to the active supplement, taken once daily in the morning for 30 days. Receives: Dietary Supplement: Placebo |
| Leonurus 500 mg | Experimental | Participants in this arm will receive a standardized oral supplement containing 500 mg of Leonurus cardiaca formulated in phospholipids, taken once daily in the morning for 30 days. Receives: Dietary Supplement: Leonurus cardiaca extract 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SCAG (Sandoz Clinical Assessment-Geriatric) score
Anxiety and neurovegetative symptoms will be assessed using the SCAG scale at baseline, 14 days, and 30 days. The SCAG includes items scored from 0 (absent) to 4 (very severe), providing a composite measure of mood, anxiety, headache, and sleep quality.
Measured: Baseline, week 1 and week 4
Secondary outcomes (11)
Change in Perceived Stress Questionnaire (PSQ) score
Stress perception will be assessed across four domains (worries, tension, joy, and demands) using the PSQ ( Perceived Stress Questionnaire), a 14-item survey. The total score ranges from a minimum of 0 to a maximum of 56. Higher scores on the scale indicate higher perceived stress and generally reflect a worse outcome in terms of stress-related well-being.
Measured: Baseline, week 1 and week 4
Change in Hamilton Anxiety Rating Scale (HAM-A) score
The severity of anxiety symptoms will be evaluated using the HAM-A scale, which consists of 14 items each scored from 0 to 4. Total score ranges from 0 (no anxiety) to 56 (severe anxiety).
Measured: Baseline, week 1 and week 4
Change in SF-12 Health Survey score
The Short Form Health Survey (SF-12) will be used to evaluate physical and mental well-being. Two summary scores (Physical and Mental Component) will be analyzed. It measures health status through summary scores for the physical (PCS-12) and mental (MCS-12) components. PCS-12 and MCS-12 summary scores are standardised to have mean 50 and standard deviation 10 in the general US population
Measured: Baseline, week 1 and week 4
Change in body weight
Body weight (kg) will be measured at baseline and at day 30.
Measured: Baseline and week 4
Change in Body Mass Index (BMI)
BMI (kg/m²) will be calculated from measured weight and height at baseline and after 30 days.
Measured: Baseline and week 4
Change in liver function tests (AST, ALT, gamma-GT)
Blood tests will be performed at baseline and after 30 days to monitor liver safety through AST, ALT, and GGT levels (U/L).
Measured: Baseline and week 4
Change in creatinine levels
Serum creatinine will be measured at baseline and day 30 to assess renal function.
Measured: Baseline and week 4
Change in thyroid-stimulating hormone (TSH) levels
Thyroid-stimulating hormone (TSH) levels will be evaluated through blood samples collected at baseline and after 30 days to assess the effect of the intervention on pituitary-thyroid axis activity.
Measured: Baseline and week 4
Change in free triiodothyronine (FT3) levels
Free triiodothyronine (FT3) levels will be assessed through blood samples collected at baseline and after 30 days to evaluate peripheral thyroid hormone activity.
Measured: Baseline and week 4
Change in free thyroxine (FT4) levels
Free thyroxine (FT4) levels will be assessed from blood samples taken at baseline and after 30 days in order to monitor thyroid gland function.
Measured: Baseline and week 4
Change in Cortisol levels
Salivary cortisol assessment: 3 evaluation tests on the day x 3 times (first visit = baseline, after 7 days, after 28 days)
Measured: Baseline, week 1 and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anxiety 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954038
- Sponsor's protocol ID
- 2312/01092024
- Other IDs
- Leonurus
- Acronym
- LEONORUS
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Dummy, Placebo-controlled Pilot Study to Evaluate the Beneficial Effects of an Oral Nutritional Supplement Based on Leonurus Cardiaca for the Improvement of Mood and Anxiety
- ClinicalTrials.gov ID
- NCT06954038
- Acronym / sponsor ID
- LEONORUS / 2312/01092024
- Conditions
- General Anxiety Disorder
- Keywords
- Leonurus cardiaca, Herbal extract, Anxiety, SCAG scale, Herbal remedy for GAD, HAM-A, PSQ, SF-12
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 1 May 2025 (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.
This study aims to evaluate the efficacy and safety of Leonurus cardiaca extract in reducing anxiety symptoms in adults with Generalized Anxiety Disorder (GAD). Sixty drug-free participants aged 20-50 years with a diagnosis of GAD will be randomly assigned to receive either Leonurus cardiaca extract or placebo for 30 days. The primary outcome is the reduction in anxiety symptoms assessed by the SCAG scale. Secondary outcomes include changes in quality of life (SF-12), perceived stress (PSQ), anxiety severity (HAM-A), and anthropometric measures. Safety will be assessed through liver, kidney, and thyroid function tests. Assessments will be conducted at baseline, day 14, and day 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Leonurus 250 mg | Experimental | Dietary Supplement: Leonurus cardiaca extract 250 mgParticipants in this arm will receive a standardized oral supplement containing 250 mg of Leonurus cardiaca formulated in phospholipids, taken once daily in the morning for 30 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants in this arm will receive a placebo identical in appearance to the active supplement, taken once daily in the morning for 30 days. |
| Leonurus 500 mg | Experimental | Dietary Supplement: Leonurus cardiaca extract 500 mgParticipants in this arm will receive a standardized oral supplement containing 500 mg of Leonurus cardiaca formulated in phospholipids, taken once daily in the morning for 30 days. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 20 to 50 years
- Diagnosis of a generalised anxiety disorder (GAD), with manifestations occurring for >= 6 months that include excessive worry, poor concentration, restlessness, muscle tension, irritability, fatigue and difficulty sleeping
Key exclusion criteria (7 listed)
- Women who are pregnant or breastfeeding
- Use of hormonal contraceptives in the last 3 months
- Current diagnosis of major psychiatric disorders (e.g., major depressive disorder, severe anxiety disorders, schizophrenia, bipolar disorder)
- Known endocrine disorders (e.g., hypothyroidism, hyperthyroidism, diabetes)
- Use of medications that could affect mood or the menstrual cycle (e.g., SSRIs, anxiolytics, antipsychotics)
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 |
|---|---|---|
| Leonurus cardiaca extract 250 mgParticipants will receive a dietary supplement containing 250 mg of Leonurus cardiaca extract formulated in phospholipids. The supplement is administered as a single oral capsule, once daily in the morning, for 30 consecutive days. | Dietary supplement | Leonurus 250 mg |
| PlaceboParticipants will receive a placebo capsule identical in appearance to the active supplement, administered twice daily for 30 consecutive days. | Dietary supplement | Placebo |
| Leonurus cardiaca extract 500 mgParticipants will receive a dietary supplement containing 500 mg of Leonurus cardiaca extract formulated in phospholipids. The supplement is administered as a single oral capsule, once daily in the morning, for 30 consecutive days. | Dietary supplement | Leonurus 500 mg |
Primary outcome
Change in SCAG (Sandoz Clinical Assessment-Geriatric) score
Time frame: Baseline, week 1 and week 4
Anxiety and neurovegetative symptoms will be assessed using the SCAG scale at baseline, 14 days, and 30 days. The SCAG includes items scored from 0 (absent) to 4 (very severe), providing a composite measure of mood, anxiety, headache, and sleep quality.
11 secondary outcomes
Change in Perceived Stress Questionnaire (PSQ) score
Time frame: Baseline, week 1 and week 4
Change in Hamilton Anxiety Rating Scale (HAM-A) score
Time frame: Baseline, week 1 and week 4
Change in SF-12 Health Survey score
Time frame: Baseline, week 1 and week 4
Change in body weight
Time frame: Baseline and week 4
Change in Body Mass Index (BMI)
Time frame: Baseline and week 4
Change in liver function tests (AST, ALT, gamma-GT)
Time frame: Baseline and week 4
Change in creatinine levels
Time frame: Baseline and week 4
Change in thyroid-stimulating hormone (TSH) levels
Time frame: Baseline and week 4
Change in free triiodothyronine (FT3) levels
Time frame: Baseline and week 4
Change in free thyroxine (FT4) levels
Time frame: Baseline and week 4
Change in Cortisol levels
Time frame: Baseline, week 1 and week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Leonurus cardiaca extract 250 mg and Leonurus cardiaca extract 500 mg in people with General Anxiety Disorder, run by Azienda di Servizi alla Persona di Pavia.
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariangela Rondanelli (+39 0382381749, mariangela.rondanelli@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SCAG (Sandoz Clinical Assessment-Geriatric) score (time frame: Baseline, week 1 and week 4). 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 25 Nov 2025.