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The value of treating refractory secretory otitis media with acupuncture and traditional Chinese medicine at the same time

Early Phase 1
Recruiting
Conditions
Otitis Media with Effusion
Registration Number
ITMCTR2024000003
Lead Sponsor
Peking University First Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Adult refractory secretory otitis media patients, as follows:
(1) Age 18-70 years old;
(2) Patients diagnosed with OME through otoscopy, pure tone audiometry, and acoustic immittance examination, and their medical history was less than 3 months;
(3) Eustachian tube pressure measurement score (TMM score) 0-1 score;
(4) refusal of invasive treatment, and TCM syndrome differentiation for spleen deficiency and dampness syndrome;
(5) Informed consent, can cooperate with treatment and follow-up, and sign informed consent

Exclusion Criteria

(1) fluctuating sensorineural deafness;
(2) Otoscopy examination of tympanic membrane and promontory adhesion or external otitis (external ear canal exudation, fungal infection, etc.);
(3) Abnormal opening of eustachian tube is clearly found;
(4) Eligible for surgical treatment due to other nasal, sinus or ear diseases;
(5) A history of middle ear, nasal cavity and nasopharyngeal surgery on the affected side;
(6) A history of cleft palate or other malformations or related surgical repair;
(7) A history of head or neck surgery or radiotherapy;
(8) Patients with ciliary immobility syndrome;
(9) The expected survival of malignant tumors was less than 12 months;
(10) The investigator believes that the patient has other conditions that are not suitable for participation in this study.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical response rate after 8 weeks of treatment;
Secondary Outcome Measures
NameTimeMethod
A-B gap;ETDQ-7 score;Valsalva action;Clinical response rate after 2 weeks of treatment;Clinical response rate after 4 weeks of treatment;TMM score;
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