Evaluation of the add-on effect of a traditional nutraceutical supplement ‘Nasaamrutam ’ with Anu Taila Pratimarsha Nasya and Shirishavaleha orally in the management of Vataja Pratishyaya (Allergic rhinitis) - An open-label double-arm randomized controlled clinical trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
研究概览
简要总结
Vataja Pratishyaya, described in Ayurveda as a Nasagata Roga, closely correlates with allergic rhinitis, a highly prevalent IgE-mediated inflammatory condition affecting the nasal mucosa. Allergic rhinitis significantly impairs quality of life and has a rising prevalence in India and globally, especially among adolescents. Conventional treatments provide symptomatic relief but are often associated with adverse effects and poor long-term compliance. Hence, there is a growing need for safe, effective, and holistic alternatives. Ayurveda offers well-established therapeutic modalities for Vataja Pratishyaya, including Anu Taila Pratimarsha Nasya for preventive and curative care of nasal disorders and Shirishavaleha for its anti-allergic, anti-inflammatory, and immunomodulatory properties. Previous clinical evidence has shown notable symptomatic improvement with this combination. The present study aims to evaluate the add-on effect of a traditional ready-to-drink nutraceutical supplement, Nasaamrutam, when combined with Anu Taila Pratimarsha Nasya and Shirishavaleha.
Nasaamrutam, formulated with ingredients such as poppy seeds, black pepper, almonds, nutmeg, cardamom, and muskmelon seeds, is traditionally valued for respiratory soothing, immune support, and anti-inflammatory actions. This open-label, double-arm randomized controlled clinical trial seeks to assess whether the addition of Nasaamrutam enhances therapeutic outcomes in Vataja Pratishyaya compared to the standard regimen alone, while also improving palatability and patient compliance with minimal side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Presence of Kshavathu (sneezing) as a mandatory symptom. 2.Patients having 3 or more diagnostic symptoms (either intermittent or persistent pattern) of Vataja Pratishyaya,i.e., i.Nasasrava (rhinorrhea) ii.Nasauparodha (nasal blockage) iii.Mukhashosha (dry mouth) iv.Shirashoola (headache) v.Nasa–bhru kandu (itchy nose –eyebrow).
- •for a minimum of one year immediately preceding the study- Screening Visit.
排除标准
- •1.Patients having lower respiratory tract infection.
- •2.Upper respiratory tract complaints such as nasal polyposis, nasal tumors, CSF rhinorrhea.
- •3.Patients with adenotonsillar hypertrophy, craniofacial syndromes, or neuromuscular diseases.
- •4.Patients with history of nasal surgery.
- •5.Other respiratory infectious conditions such as tuberculosis, pleural effusion, emphysema, lung abscess, bronchiectasis, pneumonia, pleurisy,etc.
- •6.Congenital anomalies of respiratory tract or rhinitis due to trauma.
- •7.Patients suffering from chronic debilitating diseases like HIV, Hepatitis-B, immuno- compromised patients etc.
- •8.Patients suffering from systemic diseases such as hypertension , diabetes mellitus etc.
- •9.Patients not willing to participate in the study.
研究者
Dr Aastha Agrawal
All India Institute of Ayurveda
