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A multicenter randomized controlled clinical study on the XBYL prescription in the treatment of moderate to severe adenoids hypertrophy in children

A multicenter randomized controlled clinical study on the XBYL prescription in the treatment of moderate to severe adenoids hypertrophy in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000848
Enrollment
Unknown
Registered
2024-12-20
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Adenoid hypertrophy

Interventions

Chinese medicine group:XBYL prescription (granule), oral
Western medicine group:Mometasone furoate nasal spray, nasal, combined with montelukast sodium chewable tablets, oral

Sponsors

The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for moderate to severe adenoid hypertrophy in children and are unwilling to undergo surgical treatment; (2) Age 3 ~ 12 years old gender is not limited; (3) The informed consent process is in accordance with the regulations and the legal guardian or the participating children (> 8 years old) jointly sign the informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (1) Patients who have undergone adenoidectomy; (2) Patients with severe nasal septum deviation nasal polyps nasal masses laryngeal and tracheal diseases etc. that cause breathing difficulties; (3) Patients who have suffered from acute upper and lower respiratory tract infections in the past 2 weeks; (4) Patients with metabolic or immunodeficiency diseases as well as severe dysfunction of important organs such as the heart liver kidney and brain; (5) Patients who have used corticosteroids antibiotics or immunomodulatory drugs in the past 4 weeks; (6) Patients who are allergic to the experimental drugs; (7) Patients who in the judgment of the researchers have other diseases or conditions that reduce the possibility of enrollment or complicate enrollment such as unstable living environment inconvenient transportation etc. which are likely to cause loss to follow-up.

Design outcomes

Primary

MeasureTime frame
Points for primary symptoms;

Secondary

MeasureTime frame
Points for secondary symptoms;Adenoid size;OSA-18 Quality of life score;Operation rate;

Countries

China

Contacts

Public ContactLei Xiong and Xi Ming

The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)

xlluck@sina.com13987676677

Outcome results

None listed

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