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Clinical Trials/CTRI/2022/08/044908
CTRI/2022/08/044908Not yet recruitingNot Applicable

PHARMACEUTICAL ANALYTICAL AND CLINICAL STUDY OF HERBAL NASAL SPRAY FOR ALLERGIC RHINITIS – PILOT STUDY

Department of Rasashastra and Bhaishajya Kalpana1 site in 1 country12 target enrollmentStarted: January 9, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
12
Locations
1
Primary Endpoint
Assessment of the symptoms of Allergic Rhinitis

Study Overview

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 pratishayalike Tanu Nasa Srava,Shirashoola, and Kshavathuare 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.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Assessment of the symptoms of Allergic Rhinitis

Time Frame: 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 Outcomes

  • CBC(Absolute eosinophilic Count)

Investigators

Sponsor
Department of Rasashastra and Bhaishajya Kalpana
Sponsor Class
Private medical college

Study Sites (1)

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