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

Varuni BG
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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.
一项开放标签临床研究评估“无瘤DS”改善便秘的安全性和有效性
背景:便秘是普通人群中常见的胃肠道疾病。尽管有大量完善和安全的治疗方案,但对许多患者来说,这种改善并不令人满意。这引起了人们对便秘替代治疗策略的兴趣。方法:这项开放标签、非比较单组临床研究评估了多草药制剂Anuloma DS(每天睡前1片)改善30例功能性便秘成年患者排便的疗效和安全性。患者在基线(第1次访问,第0天)进行评估,并在第30±2天的第2次访问(第7天±2天)、第3次访问(第14天±2天)和第4次访问(研究结束)期间进行随访。结果:从第7天到第14天和第30天,每周自发排便的平均次数显著增加。所有便秘症状,如腹胀(aadmana)、腹痛/不适(aanaha)、排便不完全的感觉和排便时的紧张感,以及SGA和PGA评分都得到了显著改善。结论:空肠肿治疗慢性功能性便秘疗效显著。研究参与者没有报告与治疗相关的副作用。
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