PHARMACEUTICO- ANALYTICAL AND CLINICAL STUDY OF PIPPALYADI NASAL SPRAY IN VATAJA PRATISHYAYA WITH SPECIAL REFERENCE TO ALLERGIC RHINITIS
试验速览
- 阶段
- 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
- Relief of Symptoms of Vataja Pratishyaya(Allkergic Rhinitis
研究概览
简要总结
Ayurveda is a science which deals with many unique therapies, which is intended to remove the impurities from the roots. In this busy life, people do dislike to visit the hospitals and carry over the therapies for long period of time, which makes people attracted to the instant therapies which relieves the symptoms faster.
In charaka samhitha, Shira is considered as uttamanga (1), which includes Nasa, Netra, Karna and Mukha. One such disease pertaining to Nasa is Vataja Pratishyaya, which is characterized under nasagata rogas. It is described from samhitha kala in bruhatrayee as well as laghutrayee.
Worldwide prevelance is 10-30% in adults, 40% in children(2).The nasal route of drug delivery can be used for both local and systematic drug delivery. For instance, localized nasal drug delivery is usually used to treat conditions related to nasal cavity, such congestion, rhinitis, sinusitis and allergic condition etc. A diverse range of drugs including corticosteroids, anti-histamines, anticholinergic and vasoconstrictors can be administered locally. The nasal delivery seems to be a favourable way to circumvent the obstacles of blood-brain barrier.
The formulation Pippalyadi Nasya is chosen from Yogaratnakara (3), where in the drugs contain teekshna guna which is responsible for the action of decongestion. The pharmacological activity of the drugs shows its potent Immune stimulatory, Cough suppressor, Anti- histamine. Hence this formulation has been chosen in Pratishyaya.
The modification of the dosage form i.e, Nasal spray helps the mankind with the easy administration. It also helps the peoples who have busy schedule and who are not able to visit the hospitals, an easy method which can be administered immediately. As per the reference the dosage form of the formulation is swarasa. The same has to be converted into another dosage form with same ingredients i.e, Arka. This arka is further modified into nasal spray to increase its shelf life and also for easy administration. The Nasal spray dosage form is cost-effective, easy to carry. Hence “PHARMACEUTICO- ANALYTICAL AND CLINICAL STUDY OF PIPPALYADINASAL SPRAY IN VATAJA PRATISHYAYA WITH SPECIAL REFERENCE TO ALLERGIC RHINITIS” has been taken.
PLAN OF STUDY –
GROUP A (Trial group) – Pippalyadi Nasal spray to each nostril thrice a day
2 Sprays = 0.16ml (13)
GROUP B (Control group)- Bresol Nasal Spray to each nostril thrice a day
2 sprays= 0.16ml Intervention Period: 7 Days
Assessment schedule:
On 0th Day
On 8th Day
Follow Up: On 15th Day
Total study duration: 15 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •1.Subjects fulfilling the diagnostic criteria 2.Subjects of all gender aged between 18-60 years will be selected 3.Subjects fit for Vataja Pratishyaya(Allergic Rhinitis).
排除标准
- •1.Subjects with Nasal polyp, Epistaxis and previous history of surgery for Nasal and paranasal sinuses are excluded.
- •2.Subjects having any systemic diseases.
- •3.Other types of Rhinitis like Atrophic Rhinitis and Rhinitis Sicca, Rhinosporidiosis and Infective Rhinitis.
- •4.Pregnant Women and Lactating Mothers.
结局指标
主要结局
Relief of Symptoms of Vataja Pratishyaya(Allkergic Rhinitis
时间窗: 2nd day, 8th day, 15th day
次要结局
- TNSS Score reduction(Nasal Cytology cel count reduction)
研究者
Dr Chethan Kumar R
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL