Clinical evaluation of an Ayurvedic formulation in the management of Allergic Rhinitis-A pilot study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To evaluate the effect of Ayurvedic formulation in terms of Control of Allergic Rhinitis and Asthma Test
研究概览
简要总结
The very fact that while describing the diseases of nose in Sushruta Samhita, one separate chapter has been devoted to Pratishyaya in Uttartantra iterates the importance of the same; classified into five types on the pathological basis viz. Vataja, Pittaja, Kaphaja, Raktaja and Sannipataja. Though it has been said that the disease Pratishyaya in the initial phase, is a curable entity, in chronic course it may lead to Dushta Pratishyaya and then present with many associated complications with changed prognosis as well.
On the basis of clinical features, Ayurvedic scholars today acknowledge to correlate Vataja Pratishyaya with Allergic Rhinitis (AR), a common ENT problem in modern literature. Because of being in direct contact with external environment nose is exposed to lot of microorganisms, allergens and environmental pollutants present in the atmosphere. If this stage is not properly treated, it will cause the mucosal changes in nostrils and result into turbinate hypertrophy, nasal polyps, allergic bronchitis etc.
Allergic rhinitis is also associated with otitis media, Eustachian tube dysfunction, sinusitis, nasal polyps, allergic conjunctivitis, and atopic dermatitis. It may also contribute to learning difficulties, sleep disorders etc.
The lack of curative treatment is necessitating the other health systems to provide a remedial treatment. The world has many expectations from Ayurvedic science in the treatment of AR.As mentioned earlier; AR is very much similar to Vataja Pratishyaya and as per the Ayurvedic literature, it is a curable disease. One research thesis work was carried out at I.P.G.T. & R.A., Jamnagar with the protocol of Ashwagandhadi compound, Shirishadi Kwatha and Anu Taila Nasya. Significant results were found in this research work. By keeping this fact in mind the same protocol has been proposed here.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients either sex aged between 18 to 65 years.
- •Clinical diagnosis persisting symptoms of Allergic rhinitis, X-ray (PNS), Nasal endoscopy and laboratory investigations etc.
- •Able and willing to participate and provide signed informed consent.
排除标准
- •1.History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis.
- •2.History of non allergic rhinitis, chronic sinusitis or serve asthma.
- •3.Patients with nasal anatomical defects (deviated nasal septum).
- •4.Patients with acute episodes i.e. fever/earache/headache.
- •5.Patients with associated tonsillitis or airway obstructions (adenoids).
- •6.Has a nasal condition likely to affect the outcome of the study.
- •Corticosteroids Nasal drops, Leukotriene antagonists, Nasal vasoconstrictors.
- •8.Pregnant ladies and Lactating mothers.
- •9.Patients suffering from any debilitating chronic disease like tuberculosis, Uncontrolled Diabetes mellitus 10.Any unstable cardio-vascular diseases 11.Patients with evidence of malignancy.
- •12.Patients with concurrent hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit or Renal Disorders (defined as S.
- •creatinine> upper limit of Lab.
- •value), Pulmonary Dysfunction (Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]) 13.Patient has an acute mental disorder 14.Patients who are currently participating in any other clinical trial.
结局指标
主要结局
To evaluate the effect of Ayurvedic formulation in terms of Control of Allergic Rhinitis and Asthma Test
时间窗: one month
次要结局
- Not applicable(Not applicable)