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Clinical and Basic Research on Yinbei Granules in the Treatment of Children with Adenoid Hypertrophy and Phlegm Accumulation Syndrome

Clinical and Basic Research on Yinbei Granules in the Treatment of Children with Adenoid Hypertrophy and Phlegm Accumulation Syndrome

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083549
Enrollment
Unknown
Registered
2024-04-28
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

adenoidal hypertrophy

Interventions

Traditional Chinese Medicine Group:Honeysuckle 9g, Fritillaria thunbergii 9g, Forsythia suspensa 9g, oyster 15g, burdock 9g, magnolia 6g, mint 6g, Atractylodes macrocephala 9g, Astragalus membranaceus
Western medicine group:Oral administration of Montelukast sodium tablets: 3+~6 years old, 4mg each time, once every night
6+to 14 years old, 5mg per dose, once per night. Pingqi (Menglujite Sodium Tablets), Lunanbeite Pharmaceutical Co., Ltd., Product Approval Number: National Pharmaceutical Approval Letter H20083372. Ea

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria and traditional Chinese medicine syndrome differentiation criteria for adenoid hypertrophy; (2) Select children aged 3-14 years old, regardless of gender; (3) Those who have obtained informed consent from their legal guardians and are able to cooperate with treatment.

Exclusion criteria

Exclusion criteria: (1) Not meeting inclusion criteria (2) Individuals who have received other medications or surgical treatments in the past 2 weeks or have participated in clinical trials of other related medications. (3) Individuals with severe deviation of the nasal septum and respiratory distress caused by obesity, nasal polyps, upper airway neuromuscular tension, laryngeal and tracheal diseases, etc; (4) Individuals with severe liver and kidney diseases, cardiovascular diseases, endocrine disorders, hematological disorders, and neurological disorders; (5) Individuals who are known to have allergies to the drugs in this prescription.

Design outcomes

Primary

MeasureTime frame
Thickness of adenoids/width of nasopharyngeal cavity(A/N);

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Points;Disease specific quality of for children with obstructive sleep apnea 18 items survey(OSA-18);Apnea-HypopneaIndex(AHI);

Countries

China

Contacts

Public ContactZheng Xue/Lirong Huang

Shanghai Municipal Hospital of Traditional Chinese Medicine

hlrorpop@163.com+86 134 0209 9680

Outcome results

None listed

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