A prospective, randomized, open label, parallel group, comparative clinical trial to evaluate the safety and efficacy of combination of herbal oral capsule and rectal medication to improve gut health of type 2 diabetic patients having chronic kidney disease (CKD)

Background

Chronic kidney disease (CKD) is a major health concern globally, with more than 850 million people suffering from it. Several studies have been carried out to reduce inflammation in CKD patients; and to study the relationship between gut microbiota and inflammation.

Objective

The effect of herbal formulations to improve the gut flora and reduce inflammation has not been studied earlier. The study aims to evaluate effect of herbal formulation combined with standard of care (SOC) treatment compared to SOC.

Methods

A prospective, randomized, parallel group clinical trial was planned on 90 patients split equally into standard of care (SOC) with herbal treatment (IP) and only SOC groups. The change in the abdominal pain score, percent change in the pathogenic and non-pathogenic microbiome were the key endpoints of interest. The safety assessment was in terms of adverse events, changes in hematological and biochemical parameters.

Results

The demographic and other patient characteristics showed statistically non-significant differences between two groups. On day 90, the median abdominal score in SOC + IP group (2.00) was significantly lower than that of SOC group (3.00) (p = 0.002). The quality of life score improved significantly in SOC + IP group (p < 0.001), unlike SOC group. There was significant reduction in pathogenic microbes in SOC + IP group; however, the reduction in non-pathogenic microbes was non-significant in this group. The adverse events (AEs) were in mild form, and the proportion of patients with AEs differed non-significantly between two groups.

Conclusion

The IP supplementation along with SOC significantly improved the GUT micro flora, and improved the overall quality of life of CKD patients. This treatment combination can be practiced for effective patient management.