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

The efficacy of Shatyadhi churna in the management of vataja pratisyaya (allergic rhinitis) in children- A randomized controlled clinical trial.

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023517
Enrollment
60
Registered
2020-02-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J309- Allergic rhinitis, unspecified

Interventions

Intervention1: Shatyadhi churna: Shatyadhi churna -5gm for age group 6-11 years and 6.5gm for age group 12-16 years, daily in 2 divided doses for a period of 28 days. Control Intervention1: Syrup Levo

Sponsors

All India Institute of Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. 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].Timepoint: 0 day, 8th day, 15th day, 22nd day, 29th day and during follow up.

Countries

India

Contacts

Public ContactDr Mahapatra Arun Kumar

All India Institute of Ayurveda

ayuarun@gmail.com8506821947

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026