A Clinical study to evaluate efficacy and safety of Softovac Liquifibre in the Management of Functional Constipation and Irregular Bowel Habit-An Open Label, Randomized, Comparative, Multi centric, Interventional, Prospective, Clinical Study

It is an open label, randomized, comparative, multi centric, interventional, prospective, clinical study to evaluate efficacy and safety of Softovac Liquifibre in the management of functional constipation and Irregular Bowel Habit. The study will be carried out in two cohort. Cohort 1 will have adult population and cohort 2 will have children and teenagers. The study will be carried out at three to four centers in India. In cohort 1, subjects will be randomized to either Softovac Liquifibre group or milk of magnesia + Liquid paraffin group. Subjects in Softovac Liquifibre group will be given 20 ml Softovac Liquifibre at bedtime with water for 14 days and subjects in milk of magnesia + Liquid paraffin group will be given 10 ml of milk of magnesia + Liquid paraffin at bedtime with water for 14 days.  All the subjects will be asked to stop given medication after 14 days and will be followed for next seven days to observe recurrence of symptoms of functional constipation and irregular bowel habit. In cohort 2, subjects will be given 5 to 10 ml Softovac Liquifibre at bedtime with water for 14 days. All the subjects will be asked to stop given medication after 14 days and will be followed for next seven days to observe recurrence of symptoms of functional constipation and irregular bowel habit. Primary objective of cohort 1 and 2 will be to assess change in frequency of bowel movements. Secondary objectives of cohort 1 and 2 will be to assess change in stool form, changes in symptoms of functional constipation including straining on defecation, sensation of incomplete evacuation, sensation of ano-rectal blockage, manual maneuvers required & average time spent for bowel evacuation, changes in associated clinical symptoms including headache, belching, flatulence, abdominal distension/bloating, acidity, average duration of action (from the time of consuming tablets to first bowel movement), global assessment of overall change as per the investigator and subject, assessment of tolerability of study products as per the investigator and subject. Additionally in cohort 1, assessment of laboratory investigations such as CBC, ESR, Hb%, Blood sugar fasting, Liver profile and Renal Profile will be done. 

Summary of Results:

It can be concluded from the results of the study that Softovac Liquifibre was significantly effective in increasing frequency of bowel movements in adults and children suffering from functional constipation and irregular bowel habit. Softovac Liquifibre was significantly effective in softening stool, reliving straining on defecation, sensation of anorectal blockage and requirement of manual maneuvers in children and adults. Time spent for defecation was significantly reduced after usage of Softovac Liquifibre in adults and children. Symptoms associated with constipation, viz. headache, acidity, belching, flatulence, and abdominal bloating/distension significantly improved after usage of Softovac Liquifibre in adults and children. Symptoms and associated symptoms of functional constipation did not recur on day 21 after stoppage of treatment from day 14 onwards both in adults as well as in children suggesting non-habit-forming nature of Softovac Liquifibre. The results of the study also showed all parameters comparable (non significantly different) with current market leading formulation for functional constipation. Softovac Liquifibre can be recommended as a safe and effective remedy for functional constipation and irregular bowel habit in adults and children.