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A Clinical Study to see the effectiveness of Guda-Haritaki (Jaggery with Terminalia Chebula fruit) in Kaphaja Pratishaya (Allergic Rhinitis) in children ?

Phase 4
Completed
Conditions
Health Condition 1: J310- Chronic rhinitis
Registration Number
CTRI/2019/04/018778
Lead Sponsor
Dattatray Chavan
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
197
Inclusion Criteria

Children are with symptoms of Kaphaja Pratishaya (Allergic Rhinitis) of age 6 to 12 years1.

Patients will be selected irrespective of sex and religion.

Patients, whose parents are willing to participate their child in the study and

are ready to sign informed consent form will be selected for the study.

Children with symptoms of Allergic Rhinitis occur for > 4 days per week and / or for > 4 consecutive weeks at a time.

The laboratory finding of increased numbers of eosinophils in the nasal mucosal smear (presence of > 4 % eosinophils for 6 to 10 years of age and >10 % eosinophils for 11 to 12 years of age) and elevated Total Serum IgE concentration ( > 20 IU/ml)that patients will be selected.

Exclusion Criteria

Patients with nasal abnormalities like D.N.S., Nasal polyps, adenoid and tonsilar hypertrophy.

Patients with acute respiratory infection or severe concomitant disease (Tuberculosis, Pneumonia).

Malnourished child.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate the effect on change in symptoms (Nasal congestion, Nasal obstruction, Nasal itching, Clear Rhinorrhea, Sneezing and conjuntival irritation) of Allergic Rhinitis at 28th day. <br/ ><br> <br/ ><br>To evaluate the effect on change in eosinophils in nasal smear, serum IgE concentration and Absolute eosinophil count (AEC) at 28th day.Timepoint: 28th day.
Secondary Outcome Measures
NameTimeMethod
To evaluate the effect on change in symptoms (Nasal congestion, Nasal obstruction, Nasal itching, Clear Rhinorrhea, Sneezing and conjuntival irritation) of Allergic Rhinitis at 14th day. <br/ ><br> <br/ ><br>Quality of life in children with Allergic Rhinitis at the first follows up visit i.e. at 14th day, 28th day and on 45th day.Timepoint: 14th day, 28th day and on 45th day.
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