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

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.

An Open-label Prospective Noncomparative Clinical Study to Evaluate the Efficacy and Safety of Beliv: An Ayurvedic Medicine in Improving Liver Function

An open-label prospective noncomparative study was conducted to examine the efficacy and safety of Beliv tablet, a polyherbal Ayurvedic medicine, in 30 adult patients suffering from liver disorders. Two tablets were administered daily for 56 days. Patients were evaluated at Day 0, Day 21, Day 42 and at Day 56. The primary end point of the study was a change in liver function test parameters measured by the levels of serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and total bilirubin at all assessment points. Results showed a significant reduction in the serum levels of SGOT, SGPT and total bilirubin from baseline to 21 days, 42 days and 56 days. The total icterus symptom score was also significantly reduced from 5.17 ± 2.26 (baseline) to 2.6 ± 1.48, 1.37 ± 1.13 and 0.77 ± 0.73 at Days 21, 42 and 56, respectively. The Subjective Global Assessment (SGA) decreased significantly from 3.33 ± 1.16 (Day 21) to 2.33 ± 1.16 and 1.80 ± 0.76 at Days 42 and 56, respectively. The Physician Global Assessment (PGA) score was also significantly reduced from 3.0 ± 1.02 (Day 21) to 2.07 ± 0.83 and 1.70 ± 0.79 at Days 42 and 56, respectively. A significant reduction in serum creatinine level was observed at Day 56. No adverse effects or serious adverse effects were observed during the study period. The study concluded that Beliv tablet was highly effective for the treatment of liver disorders, as evidenced by the reduction in serum levels of SGOT, SGPT, total bilirubin, icterus symptoms and PGA and SGA scores. No treatment-related side effects were reported by any of the study participants suggesting that it was safe for clinical use in humans for the treatment of liver disorders.