An Open-labeled Clinical Study to Evaluate the Safety and Efficacy of “Anuloma DS” in Improving Constipation

ABSTRACT

Background: Constipation is a common gastrointestinal problem in the general population. Despite a plethora of well-established and safe treatment options, the improvement is not satisfactory for many patients. This has prompted interest in alternative therapeutic strategies for constipation. Methods: This open-label, non-comparative single-arm clinical study evaluated the efficacy and safety of the polyherbal formulation “Anuloma DS”, 1 tablet daily at bedtime, in improving bowel movements in 30 adult patients with functional constipation. Patients were evaluated at baseline (Visit 1, Day 0) and follow-ups during Visit 2 (Day 7 ± 2), Visit 3 (Day 14 ± 2) and Visit 4 (End of the Study) at Day 30 ± 2. Results: There was a significant increase in the mean of spontaneous bowel movement every week from day 7 to days 14 and 30. All constipation symptoms such as abdominal bloating (aadmana), abdominal pain/discomfort (aanaha), feeling of incomplete evacuation and straining during passing stool improved significantly as did the SGA and the PGA scores. Conclusion: Anuloma DS is highly effective for the treatment of chronic functional constipation. No treatment-related side effects were reported by the study participants.