Evaluation of efficacy and safety of polyherbal unani formulation in Nazla Haar (Allergic Rhinitis)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.The level of Absolute Eosinophil Count and Non specific Serum IgE will be assessed by analysing the blood samples and result will be subjected to statistical analysis using paired t test.
研究概览
简要总结
Allergic rhinitis (AR) is a significant public health, medical, and economic problem in developing
countries and AR is also an important risk factor for many diseases and disorders. The incidence of
AR has been on the rise in recent years and has a significant impact on the general public. This large
increase is alarming, and it is important to better understand the prevalence status and
characteristics, sensitization patterns, and associated risk factors for AR in order to improve
treatment and develop effective prevention strategies. It emphasizes the urgent need for
understanding
. The study highlights the rising trend of allergic rhinitis and its impact on children
and adults simultaneously which in turn demand more focused studies to prevent allergic rhinitis.
In another study conducted on Indian rural population also pointed out the challenge to
otorhinolaryngologist even having facilities of advance treatment and diagnostic facilities in order
to treat the patients of allergic rhinitis
. In the modern medical treatment numerous medications is
available. However, Self-medication is widespread and leads to both over- and under-medication.
Over medication is associated with numerous side effects that lead to unnecessary costs and
increased morbidity, while under medication leads to suboptimal symptom control that
compromises quality of life . The most effective treatment is intranasal corticosteroids till date
.
Commonly available INCS are beclomethasone, triamcinolone, budesonide, fluticasone,
mometasone, and ciclesonide. INCS has been shown to improve nasal congestion and reduce sleep
disturbance and daytime sleepiness in patients. It aims to improve the quality of life during the day,
reduce fatigue and ultimately improve children’s school performance. However, dry nose, crusting
of mucous membranes, and bleeding are not uncommon. Other side effects of INCS include
transient symptoms such as nasal stinging, throat irritation, and even perforation of the nasal septum.
When it comes to the treatment of allergic rhinitis- It is a well-known fact that Continuous use of
anti-allergy and anti-inflammatory drugs always has many dangerous side effects. In order to
provide comprehensive approach to treat allergic rhinitis, Unani medicine, an alternative form of
treatment, comes forward with successful management of diseases and numerous historical
evidences available about the efficacy of Unani medicine in Nazla Haar (allegic rhinitis). These
drugs can be used for a long time without side effects. The Unani system offers a large number of
single and combination n drugs that can be administered to populations of different temperaments.
Keeping the above facts in view, it has been planned to conduct a clinical trial entitled "EVALUATION OF EFFICACY AND SAFETY OF POLYHERBAL UNANI
FORMULATION IN NAZLA HAAR (ALLERGIC RHINITIS)".
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
- 19.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient of any sex
- •Age group between 19 to 50 years
- •Patients clinically diagnosed with Nazla Haar(Allergic Rhinitis).
- •Patients with raised Total Eosinophil Count and Total Serum IgE.
排除标准
- •Age below 19 years and above 50 years.
- •Pregnancy and Lactation.
- •Patients with history of Comorbidities like Diabetes and Hypertension, Renal impairment, etc.
- •4.Patients with other disease of Nose.
结局指标
主要结局
1.The level of Absolute Eosinophil Count and Non specific Serum IgE will be assessed by analysing the blood samples and result will be subjected to statistical analysis using paired t test.
时间窗: Baseline, 1 and 2 weeks
2.The Total Nasal Symptoms Score (TNSS) will be used to assess the sum of score of the following symptoms, Nasal Congestion, Sneezing, Nasal itching, and Rhinorhoea at each time point, using four point scale (0-3).
时间窗: Baseline, 1 and 2 weeks
次要结局
- Other Allergic disorders like skin allergy may be assessed(0 and 3 weeks)
