"Comparing the Effects of Ayurvedic Treatment vs. Normal Saline for Children with Sleep Breathing Problems Due to Enlarged Adenoids"

Comparative Efficacy of Shirishavaleha and Intranasal Administration of Shadbindu Taila versus Shirishavaleha and Intranasal Administration of Normal Saline in the Management of Sleep-Disordered Breathing SDB in Children due to Adenoid Hypertrophy A two arm randomized clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072757

Enrollment

Registered

2024-08-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: G479- Sleep disorder, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children between the ages of 3 and 12 years 2.Has symptoms of SDB as determined by a Brouillette score = -1 on screening. 3.Radiological Evidence of Adenoidal nasopharyngeal ratio between 0.60 to 0.79 (mild to moderate). 4.Parents/Caretaker providing consent on the participant’s behalf.

Exclusion criteria

Exclusion criteria: 1.Adenoidal Nasopharyngeal Ratio(ANR) greater than 0.79 (severe). 2.History of tonsillectomy and/or adenoidectomy. 3.Prior diagnosis of craniofacial, neuromuscular, syndromic, or defined genetic disorders. 4.History of hemorrhagic diathesis or recurrent i.e.daily or severe epistaxis. 5.History of nasal surgery or trauma that has not fully healed. 6.Active tonsillitis or nasal infection. 7.BMI over the 97th percentile for age and gender. 8.Snoring while awake at rest. 9.Known hypersensitivity to the study drug or its formulation. 10.Has used oral, intravenous or intranasal steroids, or oral montelukast in the past 6 weeks. 11.Is known to require systemic steroids prior to the completion of the study treatment period. 12.Had treatment with any other investigational drug within 6 months prior to randomization. 13.Children who are unable to comply with study procedures or follow-up visits, or whose guardians are unable to provide informed consent or comply with study requirements, may be excluded.

Design outcomes

Primary

Measure	Time frame
1.Improvement in sleep quality by using Pediatric Sleep Questionnaire- SDB subscale i.e.Timeframe: 2nd weeks, 4th weeks, 6th weeks, and 10th weeksTimepoint: 2nd weeks, 4th weeks, 6th weeks, and 10th weeks i.e.Timeframe: 2nd weeks, 4th weeks, 6th weeks, and 10th weeks	—

Secondary

Measure	Time frame
1.Reduction of ANR (Adenoidal nasopharyngeal ratio) in children with Sleep-Disordered Breathing (SDB) due to Adenoid Hypertrophy by using Radiological evidence i.e.Timeframe: 6th weeks & 10th weeks. 2.Improvement in the quality of life of the child by using OSA-18 Quality of Life Survey i.e. Timeframe: 2nd weeks, 4th weeks, 6th weeks, & 10th weeksTimepoint: 1.Reduction of ANR (Adenoidal nasopharyngeal ratio) in children with Sleep-Disordered Breathing (SDB) due to Adenoid Hypertrophy by using Radiological evidence i.e.Timeframe: 6th weeks & 10th weeks. 2.Improvement in the quality of life of the child by using OSA-18 Quality of Life Survey i.e.Timeframe: 2nd weeks, 4th weeks, 6th weeks, & 10th weeks	—

Measure

Time frame

1.Reduction of ANR (Adenoidal nasopharyngeal ratio) in children with Sleep-Disordered Breathing (SDB) due to Adenoid Hypertrophy by using Radiological evidence i.e.Timeframe: 6th weeks & 10th weeks. 2.Improvement in the quality of life of the child by using OSA-18 Quality of Life Survey i.e. Timeframe: 2nd weeks, 4th weeks, 6th weeks, & 10th weeksTimepoint: 1.Reduction of ANR (Adenoidal nasopharyngeal ratio) in children with Sleep-Disordered Breathing (SDB) due to Adenoid Hypertrophy by using Radiological evidence i.e.Timeframe: 6th weeks & 10th weeks. 2.Improvement in the quality of life of the child by using OSA-18 Quality of Life Survey i.e.Timeframe: 2nd weeks, 4th weeks, 6th weeks, & 10th weeks

—

Countries

India

Contacts

Public ContactDr Prashik Raybhan Gajbhiye

All India Institute of Ayurveda,New Delhi

ayuarun@gmail.com8506821947

Outcome results