INTRODUCTION

Allergic rhinitis is the most common chronic disorder in the pediatric population which has a profound impact on the daily lives of children resulting in day-time fatigue, impairment of cognition and memory, irritability, sadness, impairment of sleep and limitation of activities at school as well as home. This trial is an attempt to provide an effective form of therapy among children by evaluating the efficacy of a herbal formulation of Sati, Amalaki and Trikatu in the form of churna along with guda and ghrita to be given orally in comparison to contemporary third generation drug Syrup Levocitirizine on Vataja pratisyaya with respect to allergic rhinitis.

OBJECTIVES OF THE RESEARCH

PRIMARY:

1.Reduction in the severity of cardinal feature of Vataja pratisyaya with respect to allergic rhinitis among children .

SECONDARY:

1.Reduction in nasal smear eosinophile count and IgE level. (Due to COVID-19 pandemic constraints, Nasal smear eosinphile count was not taken)

2.Improvement in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the Treatment Period. [Time Frame: Weeks 0 - 4]

Improvement in the Adolescent Rhinoconjunctivitis Quality of Life Questionnaire (AdolRQLQ) Overall Score at the End of the Treatment Period. [Time Frame: Weeks 0 - 4]

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 ].

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].

METHODOLOGY

STUDY DESIGN: OPEN LABEL RANDOMIZED CONTROLLED CLINICAL TRIAL

Sample size-60 (30 each group)

Group A: oral administration of Shatyadhi churna with guda and ghrita.

Age 6-11years- 5gm, daily in 2 divided doses

Age 12-16years – 6.5 gm, daily in 2 divided doses

Duration: 4 weeks.

Group B: oral administration of syrup Levocetirizine (2.5mg/5ml).

Age 6-11 years -5 ml once a day in evening

Age 12-16 years- 10ml once a day in evening

Duration: 2 weeks.

 Follow up: 1 month

RESULT 

The trial drug was found to be significantly effective in reducing the cardinal features of Vātaja PratiÅ›yāya within the group but on comparison with the control drug no significant difference was obtained.

In Group A IgE level significantly reduced within the groups, whereas no significant reduction was noted on comparison with the other group.

In Group-A, 10 out of 16 patients and in Group-B, 6 out of 14 patients belong to age group 6- 12 years, thus they were subjected to Pediatric Rhino-conjunctivitis Quality of life questionnaire. Whereas 6 out of 16 patients of Group-A and 6 out of 14 patients Group-B belong to age group 12- 16 years, thus they were subjected to Adolescent Rhino-conjunctivitis Quality of life questionnaire. There was significant improvement in Quality of life within each group but none of the group was found to be effective than the other.

Åšaá¹­yādhi cÅ«rṇa was able to effectively reduce the Total Nasal Symptom Score and Total Ocular Symptom Score within the trial group but could not be significantly effective than the Syrup Levocetirizine.

After the follow-up the symptoms reoccurred in many of the patients.