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PROTOCOL
Year : 2021  |  Volume : 5  |  Issue : 3  |  Page : 139-147

A multi-center collaborative double-blind study on clinical evaluation of AYUSH-SL in patients receiving mass drug administration for management of chronic filarial lymphedema—study protocol


1 Department of Clinical and Experimental Pharmacology, Calcutta School of Tropical Medicine, Kolkata, India
2 CCRAS, New Delhi, India
3 Central Ayurveda Research Institute (CARI), Bhubaneswar, Odisha, India
4 Central Ayurveda Research Institute (CARI), Kolkata, India
5 Regional Ayurveda Research Institute (RARI), Vijayawada, Andhra Pradesh, India
6 Central Ayurveda Research Institute (CARI), Punjabi Bagh, New Delhi, India

Correspondence Address:
Dr. Renu Singh
Central Council for Research in Ayurvedic Sciences (CCRAS), 6165, opp. D' Block, Janakpuri Institutional Area, Janakpuri, New Delhi 110058
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jras.jras_46_21

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BACKGROUND: Lymphatic filariasis (LF) is caused by Wuchereria bancrofti, Brugia malayi, or B. timori, the parasitic nematodes that are transmitted through mosquitoes. The World Health Organization has recommended mass drug administration (MDA) as preventive chemotherapy strategy. In Ayurveda, LF has been narrated under the heading Shlipada, and the literature also includes detailed therapeutic measures. AYUSH-SL is a formulation prepared based on the classical information of herbs used in treating LF. MATERIALS AND METHODS: This is a multi-center, prospective, parallel-group, placebo-controlled, double blind interventional study. A total of 180 participants are planned to be recruited, and the duration of the study will be 2.5 years. Diagnosed cases of filariasis (as evidenced by a positive immune-chromatographic card test or enzyme-linked immunosorbent assay or microfilariae (MF) test report) of either sex within the age group of 18–65 years present with features of filarial lymphedema of Grade I and Grade II (lower limbs) will be included in the trial. The study group will be treated with MDA and AYUSH-SL tablet. The control group will receive MDA and a matching placebo. The duration of the therapy will be of 12 weeks, and a last follow-up will be done at the 24th week. OUTCOME MEASURES: The primary outcome measure is reduction of edema computed for analysis by percentage reduction from the baseline at 4th, 12th, and 24th week. The secondary outcome measures include improvement in quality of life (QoL), which will be assessed using the Lymphatic Filariasis Specific QoL Questionnaire, and prevention of recurrence of acute episodes, which will be assessed by probing the presence and severity of episodes in the past 4 weeks. DISCUSSION: The deformities and disability due to filarial lymphedema vanquish physically as well as mentally leading to hardships in normal life. Management of filarial lymphedema is required for preventing disease progression and episodes of adenolymphangitis. The study is expected to provide evidence on the coded Ayurveda drug AYUSH-SL in the management of chronic filarial lymphedema.


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