Effect of Shatyadhi churna in the managment of allergic rhinitis (vataja pratisyaya ) among children.
- Conditions
- Health Condition 1: J309- Allergic rhinitis, unspecified
- Registration Number
- CTRI/2020/02/023517
- Lead Sponsor
- All India Institute of Ayurveda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Age group 6 to 16 years irrespective of their sex.
2. Patients having following 4 or more diagnostic symptoms of vatajapratishaya ie.
a)Kshavathu(sneezing),
b)nasa srava(rhinorrhea),
c)Nasauparodha(nasa blockage) ,
d)mukha shosha(dry mouth) ,
e)sirasoola(headache) ,
f)nasa –bru kandu(itchy nose –eyebrow)
-for a minimum of one year immediately preceding the study Screening Visit.
A minimum score of 4 on Vataja pratisyaya severity score index will be included in the study.
3. Gives written informed consent (parent/legal guardian) and assent (from the child), including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
1.Age under 6 years and above 16 years irrespective of sex.
2.Patients having lower respiratory tract infection.
3.Upper Respiratory complaints such as Nasal polyposis, Nasal tumours.
4.Patients with adenotonsillar hypertrophy, craniofacial syndromes, or neuromuscular diseases.
5.Patients with history of nasal surgery.
6.Other respiratory infectious conditions such as Tuberculosis, Plural effusion, Emphysema, Lung abscess, Bronchiectasis, pneumonia, Pleurisy.
7.Congenital anomalies of respiratory tract or rhinitis due to trauma.
8.Patients suffering from chronic debilitating diseases like JDM, HIV, HBsAg, immune compromised children etc.
9.Patients who are not willing to be included in the study protocol and also who are not willing to give the consent for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in the severity of cardinal feature of Vataja pratisyaya with respect to allergic rhinitis.Timepoint: 0 day, 8th day, 15th day, 22nd day, 29th day. allergic rhinitis and during follow up.
- Secondary Outcome Measures
Name Time Method 1.Decrease in the nasal smear eosinophil count and IgE level. <br/ ><br>2.Improvement in the Quality of Life of children in both the groups according to AdolRQLQ and PRQLQ. <br/ ><br>3.Improvement in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Treatment Period [Time Frame: Weeks 0 - 4 ]. <br/ ><br>4.Improvement in Average Daily Subject-reported AM and PM Reflective Total Ocular Symptom Scores (rTOSS) Over the 2-week Treatment Period. [Time Frame: Weeks 0 - 4].Timepoint: 0 day, 8th day, 15th day, 22nd day, 29th day and during follow up.