Clinical Studies
Clinical Studies on Food Supplements, Medical Devices, and Cosmetics
At Gruppo FarmaImpresa, we believe that scientific validation is essential to ensure the safety and efficacy of our products. We design and conduct clinical studies on food supplements, substance-based medical devices (compliant with European Regulation 2017/745 – MDR), and cosmetics, collecting ongoing market data to support the quality of our solutions.
Our cross-functional expertise enables us to directly manage every phase of the studies, collaborating with participants, ethics committees, competent authorities, and scientific and academic societies. We operate in full accordance with the latest regulations and international guidelines, ensuring the highest level of compliance, transparency, and reliability.
Our Clinical Studies
Clinical Study in Children with Asthenia
The study in 71 children with asthenia showed that the supplement Cresko (iron, royal jelly, glutamine, B vitamins) significantly improves psychosocial and emotional status. Efficacy was positively correlated with age, treatment duration, and weight gain, with no short-term adverse events.
Clinical Study on Infant Colic
The clinical study on Rilefast Ace, a medical device based on simethicone and silicon dioxide, showed a significant reduction in infant colic symptoms. Treated infants experienced less pain and crying, with particularly positive results in cases with greater initial distress.
Rilefast CE and Infant Colic: Ultrasound Analysis of Intestinal Gas
This study complements research on the effectiveness of the Rilefast CE medical device, based on simethicone and silicon dioxide, for the treatment of infant colic, assessing outcomes through ultrasound examination to measure intestinal gas content.
Clinical Study on Pulmonary Conditions
This clinical study evaluated the efficacy of the supplement Broncofurin, containing NAC, Althaea, Drosera, red poppy, and vitamin C, in improving lung function and reducing respiratory symptoms in elderly patients with stable COPD. The results show a significant improvement in symptoms after 1 and 3 months of administration.
Study on the Efficacy of Simethicone in Water in Treating Gastrointestinal Disorders in Infants
The clinical study on Secol, a medical device based on simethicone in water, demonstrated a significant reduction in gastrointestinal symptoms in infants. After two weeks of treatment, there was a marked improvement in abdominal pain, bloating, and aerophagia, with a positive impact on the quality of life of the young patients.
Revaginal Gel: Efficacy from a Vulvovaginal Clinical Study
Our clinical study confirms its efficacy in treating vulvovaginal disorders in postmenopausal women, improving comfort and quality of life. Discover Revaginal Gel, a clinically tested vaginal gel.
Clinical Study: Vulvovaginal Regeneration
Gruppo FarmaImpresa presents the results of the clinical study on the vaginal medical device FT.CE.110, formulated to regenerate vulvovaginal tissues and improve women’s intimate health. Thanks to a composition based on hyaluronic acid, lactic acid, vitamins, and botanical extracts, FT.CE.110 has demonstrated clinically significant efficacy in reducing dryness, burning, irritation, and pain during sexual activity.
Clinical Study on Fertilifast – Nutraceutical support for male infertility
Gruppo FarmaImpresa conducted an observational clinical study to evaluate the effectiveness of Fertilifast in improving seminal parameters in men affected by idiopathic infertility for more than 12 months. After 90 days of treatment, results showed a statistically significant improvement in total and progressive sperm motility, an increase in sperm concentration, and a reduction in leukocyte count, an indicator of decreased oxidative stress and inflammation.
Clinical Study on Revilan – Immune support in children with recurrent respiratory infections
Gruppo FarmaImpresa conducted a multicenter observational clinical study involving 270 children diagnosed with recurrent respiratory infections (RRI) to evaluate the effectiveness of Revilan in preventing respiratory tract infections. After 3 months of treatment, the results demonstrated a statistically significant reduction (p < 0.001) in respiratory infections, fever days, antibiotic use, and school and parental work absences.
Clinical Study on Lattawin Ovules – Clinically proven efficacy in vulvovaginal disorders
Gruppo FarmaImpresa conducted an observational clinical study to evaluate the effectiveness of Lattawin Ovules, a vaginal medical device, in the treatment of vulvovaginal disorders. After 4 weeks of treatment, patients showed a statistically significant reduction in symptoms assessed using the validated Vulvovaginal Symptoms Questionnaire (VSQ), with marked improvement in dryness, itching, burning, irritation, and dyspareunia.
Clinical Study on Reflucalm – Effectiveness in the treatment of gastroesophageal reflux in infants
Gruppo FarmaImpresa conducted a multicenter observational clinical study to evaluate the effectiveness of Reflucalm, a medical device indicated for the treatment of gastroesophageal reflux in infants. After 4 weeks of treatment, results showed a statistically significant reduction in symptoms assessed using the validated I-GERQ-R questionnaire, with marked improvement in regurgitation, crying, irritability, and feeding difficulties.
Clinical Study on Reflucalm – Efficacy in gastroesophageal reflux disease (GERD) in adults
Gruppo FarmaImpresa conducted a multicenter observational clinical study in adult patients affected by gastroesophageal reflux disease (GERD) to evaluate the effectiveness of Reflucalm, a medical device designed to protect the esophageal mucosa. After 4 weeks of treatment, results showed a statistically significant reduction in symptoms, assessed using the validated GERD-HRQL questionnaire, with a marked improvement in quality of life.
Clinical study on Artox Syringes – statistically significant improvement in pain, stiffness and function in osteoarthritis
Gruppo FarmaImpresa conducted an observational clinical study on 20 patients with knee and hip osteoarthritis to evaluate Artox Syringes. After 4 weeks, the mean WOMAC score decreased significantly from 57.1 to 19.9 (p < 0.001), with a clinically meaningful improvement in 95% of patients and no adverse events reported.
Clinical Study on Aleman – significant improvement of constipation in Parkinson’s patients
A 6-week observational clinical study on 20 Parkinson’s patients with constipation (Rome II criteria) evaluated Aleman (FOS + D-mannitol). After 30 days, weekly bowel movements nearly doubled (IR 1.97; p < 0.001), laxative use decreased markedly (IR 0.39; p = 0.004), and subjective discomfort improved significantly (−3.5 points; p < 0.001).
Clinical Study on Caregyn Ovules – symptom remission in over 89% of patients with vaginal dryness and altered pH
A clinical study on 19 women (18–72 years) with vaginal dryness and altered pH evaluated Caregyn Ovules, a vaginal medical device (FT.CE.111). After 1 week, the mean VSQ score dropped from 5.11 to 0.16 (Δ −4.95; p < 0.001), and 89% of patients achieved complete symptom remission (VSQ = 0), with improvements in itching, burning, pain, dryness, and intimate discomfort.
Rinofast: clinical efficacy in nasal congestion
The observational clinical study on Rinofast, a medical device for the treatment of nasal congestion and symptoms associated with rhinitis and rhinosinusitis, demonstrated a significant reduction in symptoms assessed through the SNOT-22 scale. Patients showed improvements in breathing, nasal secretions, sleep quality, and overall well-being, with statistically significant results