Source :　Acad J Gastroenterol & Hepatol. 4(2): 2025. AJGH.

Design:　A three-arm, randomised controlled study was designed. 75 adults with low fibre intake and meeting the Rome IV criteria for functional　constipation were recruited. The effect of the intake of Malva sylvestris extract (500 mg/day or 1000 mg/day of MALLOLAXTM capsules taken in　water) during 3 weeks was compared vs placebo in the management of mild constipation.

Methods : Primary outcome was the change in frequency of complete spontaneous bowel movements (CSBM). Secondary outcomes were　stool consistency, gastrointestinal symptoms, quality of life and mood using the Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of Life (PAC-QoL), and Depression Anxiety and Stress Scale (DASS-21). Safety and tolerability were assessed through. Safety and tolerability were evaluated through the self-reported adverse effect data collected at clinic interviews. The compliance of treatments was monitored using a delivery of diary sheet.

Conclusion : The results showed that MALLOLAXTM formulations assumed for 21 days represents a safe and effective choice for the improvement of functional constipation and associated symptoms in individuals reporting a low fibre intake. Future larger and longer randomised clinical trials are needed to confirm the properties of the extract in functional constipation and to evaluate both efficacy and safety in medium- and long-term treatments.