FindTrial
Sign In

Randomized, double-blind, placebo-controlled, multicenter clinical trial of Hanmian Granules in the treatment of adenoid hypertrophy-related pediatric snoring (lung-spleen qi deficiency and phlegm-blood stasis syndrome)

Randomized, double-blind, placebo-controlled, multicenter clinical trial of Hanmian Granules in the treatment of adenoid hypertrophy-related pediatric snoring (lung-spleen qi deficiency and phlegm-blood stasis syndrome)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002566
Enrollment
Unknown
Registered
2025-12-27
Start date
2024-04-22
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Adenoid hypertrophy-related pediatric snoring

Interventions

Experimental Group:<6 years: 1 packet Hanmian Granules bid with warm water
=6 years: 1 packet Hanmian Granules tid with warm water
Control Group:<6 years: 1 packet placebo bid with warm water
=6 years: 1 packet placebo tid with warm water

Sponsors

Shandong University of Traditional Chinese Medicine Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Aged 3-12 years (inclusive), any gender; (2) Meeting Western diagnostic criteria for adenoid hypertrophy-related pediatric obstructive sleep apnea; (3) Meeting TCM diagnostic criteria for lung-spleen qi deficiency and phlegm-blood stasis syndrome; (4) Persistent snoring >2 months, >3 nights per week; (5) Legal guardians provide informed consent. Children >8 years old must co-sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Known/suspected allergy to trial drug components or allergic constitution (2) Respiratory obstruction due to severe nasal septum deviation, obesity, nasal polyps, laryngeal/tracheal diseases (3) Comorbid upper respiratory infection, allergic rhinitis, chronic rhinosinusitis, asthma, secretory otitis media, or tonsil hypertrophy exceeding midline (4) AN ratio >0.9 or obstructive apnea-hypopnea index (OAHI) >10/hour and/or SpO2 1.5×ULN or renal function (SCr) >1.0×ULN (10) Neurological/psychiatric disorders affecting cooperation (11) Legal disabilities (blindness, deafness, mutism, intellectual/mental disorders) (12) Participation in other interventional trials within 3 months (13) Inability to take Chinese medicine or other investigator-determined exclusion criteria

Design outcomes

Primary

MeasureTime frame
Changes in sleep monitoring parameters after 4 weeks;Changes in snoring VAS score after 4 weeks;Changes in OSA-18 score after 4 weeks;TCM syndrome improvement rates after 4 weeks;—

Secondary

MeasureTime frame
AN ratio changes after 4 weeks;Emergency medication usage;—

Countries

China

Contacts

Public ContactNing Yunhong

Shandong University of Traditional Chinese Medicine Affiliated Hospital

nyh198181@126.com13793156268

Outcome results

None listed

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