Clinical evaluation of AYUSH-SL in patients receiving mass drug administration for the treatment of chronic inflammatory lymphedema, a double blind, placebo controlled, multicentric study.

Abstract

Background objectives: A 2.5-year placebo controlled double blind trial was conducted to investigate the safety and efficacy of AYUSH- SL, a poly- herbal Ayurvedic formulation on filarial lymphedema in different endemic areas of India. Lymphatic filariasis (LF) is caused by parasitic nematodes from Wuchereria bancrofti, Brugia malayi, or B. timori that are transmitted through mosquitoes. In Ayurveda, LF has been elaborately narrated under the heading Shlipada, and the literature also includes detailed therapeutic measures.

Methods: The multicenter, prospective, parallel group interventional study of a total of 180 participants were recruited within the duration through competitive enrollment. Diagnosed cases of grade I and grade II filarial lymphedema of Grade I and Grade II (lower extremities) were included in the trial. The study group was treated with MDA and AYUSH-SL or its placebo tablet.

Results: The control group had received MDA and a matching placebo. The primary outcome measure was the reduction in edema calculated for analysis by percentage reduction from baseline at the 4th, 12th and 24th week. Secondary outcome measures included improved quality of life (QoL), which was assessed using the Lymphatic Filariasis Specific QoL Questionnaire, and prevention of recurrence of acute episodes, which was evaluated by investigating the presence and severity of episodes in the past 4 weeks. The water displacement method for the evaluation of the efficacy of the intervention was shown to be highly significant compared to the baseline value (right leg; 3071.60 ± 970.482, 2828.40±829.339, p<0.001and Left leg; 3158.69 ± 1136.391, 2890.73 ±1077.475, p<0.001).

Interpretation conclusion: There was significant improvement of Quality of Life in the LF QoL Questionnaire (p <0.001) at each follow-up visit in both groups. Safety estimations on hematologic and biochemical parameters were within limits and or changes were not significant. The results revealed that AYUSH- SL is safe and effective for FL due to its comprehensive anti-inflammatory, antimicrobial, and anti-allergic activities.