A Pharmaceutical analytical and Clinical pilot trial to evaluate efficacy of Herbal nasal spray in Allergic Rhinitis.

Not yet recruiting

Conditions: Allergic rhinitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH,

Registration Number: CTRI/2022/08/044908

Lead Sponsor: Department of Rasashastra and Bhaishajya Kalpana

Brief Summary: Allergic Rhinitisis an atopic disease. Allergy is a type-1 hypersensitivity reaction thatproduces IgE antibodies to allergens i.e, pollen, dust, cold, and heat. In Ayurveda, varioussymptoms of *Vataja pratishaya*like *Tanu Nasa Srava,Shirashoola, and Kshavathu*are more relevant to symptoms of Allergicrhinitis. Multiple formulations are administered by differentroutes to treat allergic rhinitis. Nasal route act on systemic as well as localdrug delivery route. Different dosage form through nasal routes includes nasalspray, nasal drops, nasal powders, nasal gels, and nasal inserts. Long-termuse of modern nasal sprays can damage the tissue, causing infection and pain.Sometimes it swells even more than before. If the person continues to use it,this swelling can get more severe and lead to permanent swelling of the tissue.Hence Herbal nasal spray may help to overcome these side effects. Ayurvedamedicine makes up an important component of the trend toward alternativemedicine. *Bala* is an Ayurvedic medicine that is used to treatInfluenza, Headache, Nasal Congestion, Cough, and Wheezing. Secondly, Haridra has been used for ages in differentinflammatory conditions of the respiratory tract due to active ingredients likecurcumin. Previous research studies proved that Adaraka (Ginger) hasalkaloids Gingerol, gingerdione, and zingiberene which are anti-oxidant,antimicrobial, anti-inflammatory, anti-asthmatic, and Mucolytic in action. The merits of the Nasal delivery route are that it ensures rapid absorption byboth systemic and local drug delivery routes. Also, very few preparations ofNasal Spray are available in Ayurveda pharma companies that signify theindustrial applicability of the product. Hence, in this present study, anattempt will make to prepare an herbal nasal spray for symptomatic treatment ofallergic rhinitis.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 12

Inclusion Criteria

1. Subjects willing for the trial.
1. Mild to moderate cases of Allergic rhinitis.

Exclusion Criteria

1. Subjects not willing for the trial.
1. Subjects below 18 and above 60 years.
1. Cases which require surgical intervention like nasal polyps and deviated nasal septum would be excluded.
1. Patients suffering from any chronic debilitating disease like Tuberculosis, Diabetes mellitus type 2, Asthma and other respiratory or nasal problems.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the symptoms of Allergic Rhinitis	Efficacy of treatment will be analyzed by Assessment of symptoms on Gradation like 0, 1, 2, 3. Symptoms are 1)Running nose 2)Nasal blockage 3)Sneezing 4)Headache at baseline and at the end of 7 days.

Secondary Outcome Measures

Name	Time	Method
CBC	Absolute eosinophilic Count

Trial Locations

Locations (1): Parul Ayurved Hospital
🇮🇳
Vadodara, GUJARAT, India
Parul Ayurved Hospital
🇮🇳Vadodara, GUJARAT, India
Dr Neerja Thakur
Principal investigator
9780094524
neerjathakur8@gmail.com