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An innovative nutraceutical formulation for appetite control and premenstrual syndrome symptom management

Randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluating the efficacy of a nutraceutical containing Cinchona bark, Chicory root, Gentian root, Griffonia simplicifolia and Vitex agnus-castus in women with premenstrual syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12142665
Enrollment
150
Registered
2026-03-25
Start date
2024-01-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Premenstrual syndrome in women of reproductive age Urological and Genital Diseases

Interventions

Participants were assigned through 1:1 randomization using a computer-generated randomization list to receive either Agrigenina® or a placebo. Agrigenina® was administered as gastro-resistant capsules

Sponsors

NGN Healthcare—New Generation Nutraceuticals s.r.l.
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 46 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 18–46 years 2. Presence of premenstrual syndrome defined as recurrent somatic, psychological, or behavioral symptoms occurring during the premenstrual and/or menstrual phase in at least four of the previous six menstrual cycles, including the most recent one 3. Regular menstrual cycle 4. Willingness to maintain usual dietary habits and physical activity levels throughout the study period

Exclusion criteria

Exclusion criteria: 1. History of chronic diseases such as coagulopathies, diabetes, cardiovascular or renal disorders 2. Cigarette smoking or alcohol consumption 3. Use of nutritional supplements or hormonal medications during the study period 4. Allergy or hypersensitivity to dietary supplements or study product components 5. Irregular menstruation 6. Pregnancy or breastfeeding 7. History of psychological or psychiatric disorders 8. Stressful events occurring in the three months prior to the beginning of the study that could represent a confounding factor

Countries

Italy

Contacts

Public ContactFortuna Iannuzzo
fortuna.iannuzzo@libero.it+39 (0)3385257346

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026