Effectiveness of Allergy Rakshak Avaleha alone and combination with Allergy Rakshak Ghee in managing allergic rhinitis: An open label randomized controlled study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Changes in Total Nasal Symptom Score (TNSS), serum IgE levels, and eosinophil count
研究概览
简要总结
This open-label, randomized, parallel-group trial will be conducted at Arogyam Ayurvedic Allergy Hospital located in Jalandhar, Punjab, India. This aims to evaluate the effectiveness of Allergy Rakshak Avaleha alone and in combination with Allergy Rakshak Ghee for managing allergic rhinitis. Participants aged 18 to 65 with two or more nasal symptoms and a Total Nasal Symptom Score (TNSS) ≥ 2 will be enrolled. The primary objective is to assess the change in TNSS over a 28-day treatment period, while the secondary objective is to evaluate health-related quality of life (HRQoL). Participants will be divided into three groups: Group I will receive Allergy Rakshak Avaleha orally twice daily, Group II will receive Allergy Rakshak Avaleha orally twice daily along with topical Allergy Rakshak Ghee in each nostril, and Group III will receive standard therapy with levocetirizine and montelukast orally. By exploring alternative approaches to allergic rhinitis management, this study aims to potentially improve the quality of life of patients with allergic rhinitis.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Allergic rhinitis patients of both genders, aged between 18 and 65 years at the time of enrollment Presence of 2 or more nasal symptoms (sneezing, watery rhinorrhea, nasal congestion, and nasal itching) Total Nasal Symptom Score (TNSS) greater or equal to 2 (TNSS is calculated by adding scores for each nasal symptom on a four-point scale (0 means no symptoms, 1 means mild symptoms, 2 means moderate symptoms, 3 means severe symptoms), with a maximum TNSS of 12).
排除标准
- •Patients with deviated nasal septum, nasal polyps, or any clinically significant nasal anomaly Presence of upper respiratory tract infections or severe asthma, impaired hepatic and renal functions, abnormal cardiovascular or cerebrovascular conditions, or anemia, or a history of known systemic disorders Currently or previously treated for malignancy Undergoing steroid therapy Already receiving medications for allergic rhinitis or receiving antihistamines Known allergies to investigational products or their ingredients Pregnant or lactating mothers Any other individuals deemed unsuitable for inclusion by the investigators.
结局指标
主要结局
Changes in Total Nasal Symptom Score (TNSS), serum IgE levels, and eosinophil count
时间窗: TNSS: 28 days and after 1 month of follow up; Serum IgE levels and eosinophil count: 28 days
次要结局
- Health-related quality of life (HRQoL)(28 days and after 1 month of follow up)
研究者
Dr Varun
Arogyam Ayurvedic Allergy Hospital, Jalandhar, Punjab