A randomised controlled parallel study to compare the efficacy of Haridrakhanda to combination of Haridrakhanda and Anutailanasya in allergic rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Nasal symptoms (watery rhinorrhea, sneezing, nasal obstruction, nasal itching) measured using the Total Nasal Symptom Score (TNSS) of allergic rhinitis patients at baseline and the end of intervention
研究概览
简要总结
This randomized controlled parallel study aims to evaluate the efficacy of Haridrakhanda alone compared to a combination of Haridrakhanda and Anutaila Nasya in managing allergic rhinitis (AR). AR, a Type 1 IgE-mediated hypersensitivity disorder, significantly impacts the quality of life by causing symptoms like sneezing, rhinorrhea, nasal congestion, and itching. Conventional treatments often fail to fully control these symptoms, leading patients to seek alternative therapies like Ayurveda.
Haridrakhanda, an Ayurvedic formulation with anti-allergic and immune-boosting properties, is widely used for AR. Nasya (nasal administration) with Anutaila, a classical Ayurvedic oil, is another traditional treatment for head and neck diseases, including AR. The study will assess the effectiveness of these treatments by measuring the Total Nasal Symptom Score (TNSS), serum IgE, and absolute eosinophil count (AEC) over four weeks.
The trial involves 140 participants, aged 18–60, who will be randomly assigned to two groups: one receiving only Haridrakhanda and the other receiving both Haridrakhanda and Anutaila Nasya. The study aims to determine whether the combination therapy is more effective than Haridrakhanda alone in reducing the severity of nasal symptoms and IgE/AEC levels. The trial will also include an analysis of the physicochemical properties of Anutaila. Outcomes will be assessed at baseline, 28 days, and 56 days post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group of 18 to 60 years at the time of enrolment, irrespective of gender.
- •Clinical symptoms for at least 1 month or more.
- •Presence of two or more nasal symptoms: watery rhinorrhoea, nasal obstruction, sneezing, and nasal itching.
- •Total Nasal Symptom Score (TNSS) of 6 or more (0 no symptoms, 1 mild symptoms, 2 moderate symptoms, 3 severe symptoms).
- •Willing to give written, informed consent to participate in this study and come for follow-ups as advised.
排除标准
- •Patients with deviated nasal septum/ nasal polyps/ nasal growth/ adenoids/ asthma.
- •Patients with impaired liver and kidney functions, anaemia, and unstable cardiovascular conditions or cerebrovascular conditions.
- •Currently or previously treated for any malignancy.
- •Patients on steroid therapy.
- •Pregnant or lactating mothers.
- •Those who have any history of drug allergy to any of the investigational products.
- •Illiterate patients without a literate relative/guardian who can explain the procedures and maintain the patient diary, • Patients suffering from chronic debilitating diseases like Uncontrolled DM, JDM, HIV, HBsAg, Non-consenting individuals Any other patients who are considered unsuitable for recruitment by the investigator.
结局指标
主要结局
Nasal symptoms (watery rhinorrhea, sneezing, nasal obstruction, nasal itching) measured using the Total Nasal Symptom Score (TNSS) of allergic rhinitis patients at baseline and the end of intervention
时间窗: Total Nasal Symptom at baseline,28th and 56th day. | IgE and AEC at Baseline and 28th day.Score
次要结局
- 1.Change in Serum Immunoglobulin E level(2.Change in Absolute Eosnophil Count (AEC))
研究者
Dr Krishna Rao S
Central Ayurveda Research Institute,Bhubaneswar