AN OPEN LABEL, NON-RANDOMIZED, CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF HOMEOPATHIC FORMULATION “KIDFLAME TABLET” IN PATIENT WITH KIDNEY STONE.

Abstract

Background:

Urolithiasis is the course or process of formation of a stone in the kidney or anywhere in the urinary tract. The development of the stones is associated with a reduced urine volume or an augmented excretion of stone-forming components such as calcium, cystine, oxalate, xanthine, urate, and phosphate. The primary outcome of this study is to assess efficacy of Kidflame tablet in Urolithiasis and overall compliance to the drug treatment. The secondary outcome is to assess the efficacy of kidflame tablets by symptomatic relief from clinical symptoms of urolithiasis and reduction or expulsion of the stone size by ultrasonography.

Methods:

This study was an open label, non-randomized, clinical study to evaluate the efficacy and safety of homeopathic formulation “Kidflame tablets” in patients with kidney stones. The Inclusion criteria was adult-Above 18 years to 60 years, both male and female. All eligible subjects who meet the Inclusion and Exclusion was enrolled into the study and were visited the study site on screening day, Day 0 (Baseline visit), Day 30 and Day 60. The 123 subjects were enrolled in this study. The primary endpoint was mean of the reduction in the size of the stone/expulsion of stone. The primary endpoint was analyzed using the p-trend test .The secondary efficacy of kidflame tablets by symptomatic relief from clinical symptoms of urolithiasis and reduction or expulsion of the stone size by ultrasonography and endpoint reduction in symptoms of Urolithiasis and percentage change in Urolithiasis Symptom Score. The secondary endpoint was analyzed using p-trend test. The p-value for trend was found out to be statistically significant.

Results:

A total of 123 samples was included in this study among them, 44 (35.8%) were female and 79 (64.2%) were male patients. The average age was 41.67± 8.67 (range, 23 – 60) years. The change over the time in vital measure was found out not to be statistically significant (p=NS). A summary of adverse events, adverse events that occurred or not worsened during treatment. Most of the patients were reported with pain, however, a smaller number of the patients expressed with worsening pain. The results show that a significant decrease in pain/colic, dysuria, number of stones, size of the stones (mm), position of stones in the kidney. Efficacy results from this study was shown more significant results with kidflame.

Conclusion:

Kidflame at dose at least three times daily had more efficacious. The adverse event was not a  higher incidence also the serious adverse event was not found. This is needed as this will help in bringing forward the positive effects of this medicine to worldwide physicians so that more patients of kidney stones can be benefitted. The Pelvis of Kidney/ Calyces of the kidney were not worsened during the treatment. The incidence rate of adverse events was low and no patients reported serious adverse events, hence demonstrating the favorable tolerability profile of Kidflame. Data from this study demonstrated the favorable safety profile of Kidflame.