Clinical evaluation of AYUSH-SL in patients receiving mass drug administration for treatment of chronic inflammatory lymphedema: A doubleblind placebo-controlled multicentric study

dc.contributor.authorMitra, Achintyaen_US
dc.contributor.authorBhuyan,, Gurucharanen_US
dc.contributor.authorMuralikrisha, Cen_US
dc.contributor.authorNaser, SMen_US
dc.contributor.authorRatha, KKen_US
dc.contributor.authorBabu, Gen_US
dc.contributor.authorVenkateswarlu, Ben_US
dc.contributor.authorDhoke, Sujataen_US
dc.contributor.authorBagchi, Chiranjiben_US
dc.contributor.authorSingh, Renuen_US
dc.contributor.authorTripathi, Arunabhen_US
dc.contributor.authorRana, Rakeshen_US
dc.contributor.authorSharma, BSen_US
dc.contributor.authorKhanduri, Shrutien_US
dc.contributor.authorGupta, Bhartien_US
dc.contributor.authorRao, BCSen_US
dc.contributor.authorKumar, Adarshen_US
dc.contributor.authorPadhi, MMen_US
dc.contributor.authorSrikanth, Nen_US
dc.contributor.authorDhiman, KSen_US
dc.contributor.authorTripathi, Santanu Ken_US
dc.date.accessioned2025-08-13T09:35:51Z
dc.date.available2025-08-13T09:35:51Z
dc.date.issued2025-06
dc.description.abstractBackground & 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 literature also includes detailed therapeutic measures. Methods: The multicenter, prospective, parallel group interventional study in which 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 mass drug administration and AYUSH-SL or its placebo tablet. Results: The control group had received mass drug administration 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 four 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 lymphatic filariasis due to its comprehensive anti-inflammatory, antimicrobial, and anti-allergic activities.en_US
dc.identifier.affiliationsRegional Ayurveda Research Institute, Ranikhet, Uttarakhand, Indiaen_US
dc.identifier.affiliationsRegional Ayurveda Research Institute, Itanagar, Arunachal Pradesh, Indiaen_US
dc.identifier.affiliationsRegional Ayurveda Research Institute, Vijayawada, Andhra Pradesh, Indiaen_US
dc.identifier.affiliationsCalcutta National Medical College & Hospital, Beniapukur, Kolkata, West Bengal, Indiaen_US
dc.identifier.affiliationsCentral Ayurveda Research Institute, Bharatpur, Bhubaneswar, Odisha, Indiaen_US
dc.identifier.affiliationsCentral Ayurveda Research Institute, Kolkata, West Bengal, Indiaen_US
dc.identifier.affiliationsRegional Ayurveda Research Institute, Vijayawada, Andhra Pradesh, Indiaen_US
dc.identifier.affiliationsRegional Ayurveda Research Institute, Vijayawada, Andhra Pradesh, Indiaen_US
dc.identifier.affiliationsSchool of Tropical Medicine, Kolkata, West Bengal, Indiaen_US
dc.identifier.affiliationsCentral Council for Research in Ayurvedic Sciences, New Delhi, Indiaen_US
dc.identifier.affiliationsCentral Council for Research in Ayurvedic Sciences, New Delhi, Indiaen_US
dc.identifier.affiliationsCentral Council for Research in Ayurvedic Sciences, New Delhi, Indiaen_US
dc.identifier.affiliationsCentral Council for Research in Ayurvedic Sciences, New Delhi, Indiaen_US
dc.identifier.affiliationsCentral Council for Research in Ayurvedic Sciences, New Delhi, Indiaen_US
dc.identifier.affiliationsCentral Ayurveda Research Institute, New Delhi, Indiaen_US
dc.identifier.affiliationsCentral Council for Research in Ayurvedic Sciences, New Delhi, Indiaen_US
dc.identifier.affiliationsCentral Council for Research in Ayurvedic Sciences, New Delhi, Indiaen_US
dc.identifier.affiliationsCentral Council for Research in Ayurvedic Sciences, New Delhi, Indiaen_US
dc.identifier.affiliationsCentral Council for Research in Ayurvedic Sciences, New Delhi, Indiaen_US
dc.identifier.affiliationsCentral Council for Research in Ayurvedic Sciences, New Delhi, Indiaen_US
dc.identifier.affiliationsJagannath Gupta Institute of Medical Sciences & Hospital, Nishchintapur, Kolkata, West Bengal, Indiaen_US
dc.identifier.citationMitra Achintya, Bhuyan Gurucharan, Muralikrishna C, Naser SM, Ratha KK, Babu G, Venkateswarlu B, Dhoke Sujata, Bagchi Chiranjib, Singh Renu, Tripathi Arunabh, Rana Rakesh, Sharma BS, Khanduri Shruti, Gupta Bharti, Rao BCS, Kumar Adarsh, Padhi MM, Srikanth N, Dhiman KS, Tripathi Santanu K. Clinical evaluation of AYUSH-SL in patients receiving mass drug administration for treatment of chronic inflammatory lymphedema: A doubleblind placebo-controlled multicentric study. Journal of Vector Borne Diseases . 2025 Jun; 62(2): 202-210en_US
dc.identifier.issn0972-9062
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/252554
dc.languageenen_US
dc.publisherWolters Kluwer – Medknowen_US
dc.relation.issuenumber2en_US
dc.relation.volume62en_US
dc.source.urihttps://doi.org/10.4103/JVBD.JVBD_61_24en_US
dc.subjectFilarial lymphedemaen_US
dc.subjectAyurvedaen_US
dc.subjectMDAen_US
dc.subjectAYUSH-SLen_US
dc.titleClinical evaluation of AYUSH-SL in patients receiving mass drug administration for treatment of chronic inflammatory lymphedema: A doubleblind placebo-controlled multicentric studyen_US
dc.typeJournal Articleen_US
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