A randomized, comparative, open clinical trial for evaluating the efficacy of PP/JLN/107/09-10 Syrup in the management of Functional Constipation

Abstract

Context: Functional constipation which has no underlying organic causes is difficult to be allopathic treatment for long term due to its side effects and undeniable effect, thus a natural balanced and compatible formulation needs to be validated. Objectives: Current study aimed to assess a poly-herbal formulation in management of functional constipation. Material and Methods: This study was 28 days, two armed, randomized, open labeled, prospective clinical study. 60 clinically confirmed cases of functional constipation patients randomized to receive orally either 2 teaspoonful of PP/JLN/107/09-10 Syrup or 1 teaspoonful of 5- 6 gm of Isabgol powder. Results were analyzed as per Rome II criteria and other associated symptoms like headache, acidity, belching, barborgysmy, flatulence and abdominal dis tension or bloating which are recorded on VAS score. Results: PP/JLN/107/09-10 scored over Isabgol on four out of six parameters of Rome II Criteria viz., frequency of bowel movement, straining at defecation, lumpy I har dstool formation, feeling of incomplete evacuation, feeling of ano-rectal blockage and manual maneuvers (p less than 0.001). Trial drugs showed comparable effects (p > 0.05) in reducing the mean scores of associated symptoms like headache, acidity, belching, borgorgysmy, flatulence and abdominal distension. However, trial drug was found to perform statistically significant result in more number of parameters in comparison to Isabgol. Conclusion: PP/JLN/107/09-10 was found to be effective and safe in reliving functional constipation.