Effect of Shatyadhi churna in the managment of allergic rhinitis (vataja pratisyaya ) among children.

Phase 2/3

Completed

Conditions: Allergic rhinitis, unspecified,

Registration Number: CTRI/2020/02/023517

Lead Sponsor: All India Institute of Ayurveda

Brief Summary: **INTRODUCTION**

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

**OBJECTIVES OF THE RESEARCH**

**PRIMARY:**

1.Reduction in the severity of cardinal feature of Vatajapratisyaya 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 nottaken)

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

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

3.Improvement in Average Daily Subject Reported AM and PMReflective 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 PMReflective Total Ocular Symptom Scores (rTOSS) Over the 2-week TreatmentPeriod. [Time Frame: Weeks 0 - 4].

**METHODOLOGY**

**STUDY DESIGN**: OPEN LABEL RANDOMIZEDCONTROLLED CLINICAL TRIAL

**Sample size**-60 (30 each group)

Group A: oral administration of Shatyadhi churna with gudaand ghrita.

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

Age 12-16years â€“ 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 inreducing the cardinal features of *VÄtaja PratiÅ›yÄya*within thegroup but on comparison with the control drug no significant difference wasobtained.

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

In Group-A, 10 out of 16 patients and in Group-B, 6 out of14 patients belong to age group 6- 12 years, thus they were subjected toPediatric Rhino-conjunctivitis Quality of life questionnaire. Whereas 6 out of16 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 Qualityof life questionnaire. There was significant improvement in Quality of lifewithin each group but none of the group was found to be effective than theother.

*Åšaá¹yÄdhicÅ«rá¹‡a*wasable to effectively reduce the Total Nasal Symptom Score and Total OcularSymptom Score within the trial group but could not be significantly effectivethan the Syrup Levocetirizine.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Age group 6 to 16 years irrespective of their sex.
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 â€“bru kandu(itchy nose â€“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.
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.

Exclusion Criteria

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.	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.	2.Improvement in the Quality of Life of children in both the groups according to AdolRQLQ and PRQLQ.

Trial Locations

Locations (1): All India Institute of Ayurveda
🇮🇳
Delhi, DELHI, India
All India Institute of Ayurveda
🇮🇳Delhi, DELHI, India
Dr Mahapatra Arun Kumar
Principal investigator
8506821947
ayuarun@gmail.com