| PROTOCOL |
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| Year : 2021 | Volume
: 5
| Issue : 3 | Page : 131-138 |
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Clinical evaluation of the efficacy of Shadbindu Taila and Chitraka Haritaki in the management of chronic rhinosinusitis: Protocol for a prospective, open-label multicenter single-arm trial
Shweta Mata1, Harbans Singh2, Deepa Makhija3, Babita Yadav3, Richa Singhal3, Bhogavalli Chandrasekhara Rao3, Rajput Shivshankar1, Bharti Gupta1, Narayanam Srikanth3
1 Central Ayurveda Research Institute (CARI), Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi, India
2 Central Ayurveda Research Institute (CARI), Central Council for Research in Ayurvedic Sciences (CCRAS), Patiala, India
3 Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi, India
Correspondence Address:
Dr. Shweta Mata
Central Ayurveda Research Institute (CARI), Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi.
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jras.jras_43_21
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BACKGROUND: The disease Pinasa (chronic rhinosinusitis disease) is a chronic nasal disease, which affects nasal canal and paranasal sinuses and the symptoms of this disease are similar to that of chronic rhinosinusitis. In Ayurvedic classics, the internal administration of Chitraka Haritaki Avaleha (CHA) and nasal instillation of Shadbindu Taila (SBT) are mentioned for the management of Pinasa. In view of the literary indication, the present work was carried out with the objective to evaluate the clinical efficacy and safety of CHA and SBT in the management of chronic rhinosinusitis. MATERIALS AND METHODS: A multicenter, single-arm, open-label clinical trial was proposed for the assessment of therapeutic efficacy of oral administration of CHA and nasal instillation of SBT. A total of 60 patients with chronic rhinosinusitis from Central Ayurveda Research Institute (CARI), New Delhi and CARI, Patiala were enrolled in this study. SBT Nasya (nasal drop to be given for three sittings, 7 days in each, with the interval of 7 days between each sitting) and CHA (6 g, twice daily after food) in the form of Avaleha (semisolid confection) were given to all participants for 42 days and the follow-up period was 28 days. The primary outcome was to assess change in SNOT (Sino-Nasal Outcome Test) scores. The secondary outcome was to assess change in RSDI (Rhinosinusitis Disability Index) scores and change in Lund-Mackay scores of computed tomography (CT) scan of paranasal sinuses. CONCLUSION: The effect of CHA and SBT nasal drop in treatment of Pinasa with special reference to chronic rhinosinusitis may provide an evidence-based complementary therapeutic approach for the management of the said condition. |
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