A randomized, double-blind, placebo-, and positive-controlled clinical pilot study to evaluate the efficacy and tolerability of standardized aqueous extracts of Terminalia chebula and Terminalia bellerica in subjects with hyperuricemia

Abstract

ObjectivesTo evaluate the efficacy and tolerability of standardized aqueous extracts of Terminalia chebula and Terminalia bellerica versus febuxostat and placebo on reduction in serum uric acid levels in subjects with hyperuricemia.Materials and methodsA total of 110 eligible subjects with hyperuricemia were enrolled and randomized to either of the five treatment groups – T. chebula 500 mg twice a day (BID), T. bellerica 250 mg BID, T. bellerica 500 mg BID, placebo BID, and febuxostat 40 mg once daily plus an identical placebo – for a duration of 24 weeks. Serum uric acid levels were measured at baseline and at the end of 4, 8, 12, 16, 20, and 24 weeks. Statistical analysis was done using GraphPad Prism Software 4.Results and interpretationAll active treatment groups showed a reduction in serum uric acid levels compared to baseline and placebo. Significant reduction in mean serum uric acid levels started as early as 4 weeks following treatment, compared to baseline, with T. bellerica (500 and 250 mg), febuxostat (P<0.001), and T. chebula 500 mg (P<0.01); an increase in serum uric acid levels was seen with placebo (P<0.05). The serum uric acid levels became steady after 16 weeks of treatment and remained the same until the end of 24 weeks. The reduction of serum uric acid levels in the T. bellerica 500 mg group was nearly twice that of the T. chebula 500 mg group as well as T. bellerica 250 mg group at all time points. T. bellerica 500 mg reduced serum uric acid levels from 8.07±0.87 to 5.78±0.25 compared to febuxostat, which reduced serum uric acid levels from 8.53±0.97 to 4.28±0.67 (P<0.001) at the end of 24 weeks. The efficacy of T. bellerica appeared to be dose dependent. All the formulations were well tolerated.ConclusionT. bellerica has the potential for treating hyperuricemia as it was devoid of any serious adverse effects in the present study. Further studies are needed to confirm this potential.

A randomized, double-blind, positive-controlled, prospective, dose-response clinical study to evaluate the efficacy and tolerability of an aqueous extract of Terminalia bellerica in lowering uric acid and creatinine levels in chronic kidney disease subjects with hyperuricemia

“…In a previous study [11] done at our department, we have reported that T. bellerica inhibited uric acid formation, which was indicative of its xanthine oxidase enzyme inhibitory activity. In our present study, it is observed that serum uric acid and serum creatinine levels have significantly improved, which in turn has led to the improvement in estimated glomerular filtration rate with all the treatment groups.…”

“…The commonly preferred agents in both overproducers and under-secretors of uric acid include xanthine oxidase (an enzyme involved in the synthesis of uric acid) inhibitors such as allopurinol and febuxostat [10]. In our previous study, we have demonstrated that Terminalia bellerica (TB) significantly decreased serum uric acid levels with no serious adverse effects, thus showing its xanthine oxidase inhibiting property and potential for the treatment of hyperuricemia [11]. Considering this, we carried out the present study to evaluate the effect of TB when compared to febuxostat in preventing the progression of CKD in subjects with hyperuricemia.…”

Evaluating the effect of black myrobalan on cognitive, positive, and negative symptoms in patients with chronic schizophrenia: A randomized, double‐blind, placebo‐controlled trial

“…It should also be noted that Terminalia chebula has been used in other clinical trials for treating hyperuricemia (Usharani, Nutalapati, Pokuri, Kumar, & Taduri, 2016), decreasing cardiovascular risk factors in patients with type 2 diabetes mellitus (Pingali, Sukumaran, & Nutalapati, 2020), and improving joint mobility in healthy overweight subjects (Lopez et al, 2017). The reported adverse effects in the previous studies were mild gastrointestinal intolerance, dyspepsia, and cramps (Lopez et al, 2017; Pingali et al, 2020; Usharani et al, 2016). But in the present study, increased libido, dry mouth, colic, and confusion were found as adverse effects of black myrobalan.…”

Majoon Halaila: A Potential Compound Formulation to Counter Premature Ageing-A Review

“…7,8,9,10 Due to its anti-ageing activity, it is recommended for the promotion of health in elderly. Hypoglcaemic effect and hypolipidemic effect 11 Anti-oxidant effect 12 Anti arthritic activity 13,14 Neuroprotective effect 15 Antigastritis effect 16 Hypourecemic effect 17 improving gastrointestinal motility 18 Cardiotonic activity , 19,20 Hepatoprotective effect 21…”