A Study to evaluate the efficacy of Guda Haritaki in prevention of Pratishyaya w.s.r to Rhinitis in childre
- Registration Number
- CTRI/2023/07/055321
- Lead Sponsor
- Dr Mahitha V
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Healthy children in the age group between 3-6 years, irrespective of the religion, gender,
and socio-economic status will be included.
2) Children with a history of 1 or more episodes of Rhinitis per month in past 3 months or more
than 6 episodes per year will be included.
3) Children whose parents are willing to sign the written consent form and follow the protocol
will be included
1) Children less than 3 years and more than 6 years of age will be excluded.
2) Children with the history of Nasal polyps, Deviated Nasal Septum, Bronchial asthma,
Pertussis, Tuberculosis, COPD, Bronchiectasis, Tropical eosinophilia, cerebrospinal fluid
rhinorrhoea, and other systemic illness and those who are on regular medication will be
excluded.
3) Children with Rhinitis secondary to Lupus, Diphtheria, Syphilis etc. will be excluded.
4) Children with Congenital anomalies of Respiratory and Cardiovascular system will be
excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of improvement in the composite overall important symptoms like <br/ ><br>1)Nasal congestion <br/ ><br>2)watery eyes <br/ ><br>3)sore throat <br/ ><br>4)sneezing <br/ ><br>5) headache etc <br/ ><br>and its intensity & frequency of recurrence in rhinitis attacks.Timepoint: Before intervention - 0th day <br/ ><br>During intervention - 30th day, 60th day <br/ ><br>After intervention - 75th day, 90th day
- Secondary Outcome Measures
Name Time Method Assessment of the improvement in recurrent rhinitis by Rhinitis Control Assessment Test (RCAT) & Pratishyaya Severity Scale in ChildrenTimepoint: Before intervention - 0th day <br/ ><br>During intervention - 30th day, 60th day <br/ ><br>After intervention - 75th day, 90th day