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Acupuncture Combined with Medication for Patients with Idiopathic Sudden Sensorineural Hearing Loss: A Prospective Randomized Controlled Trial Protocol

Acupuncture Combined with Medication for Patients with Idiopathic Sudden Sensorineural Hearing Loss: A Prospective Randomized Controlled Trial Protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000170
Enrollment
Unknown
Registered
2026-01-24
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Idiopathic sudden sensorineural hearing loss

Interventions

experimental group:Acupuncture, once a day, for 1 week. Ginkgo diterpene lactone gluconate injection, intravenous injection, 5ml each time, once a day, for 7 consecutive days
Prednisolone sodium succinate for injection, intravenous injection, 120mg daily on days 1-3, 80mg daily on days 4-6, 40mg daily on day 7
Mecobalamin injection, intravenous push, 0.5mg each time, for 7 consecutive days. One week later, take Mecobalamin tablets orally, three times a day, 1 tablet each time, for 2 consecutive weeks.
control group:Ginkgo diterpene lactone gluconate injection: Intravenous injection, 5 ml each time, once a day, for 7 consecutive days
Methylprednisolone sodium succinate for injection: Intravenous injection, 120 mg daily on days 1-3, 80 mg daily on days 4-6, 40 mg daily on day 7
Mecobalamin injection: Intramuscular injection, 0.5 mg each time, for 7 consecutive days. One week later, take mecobalamin tablets orally, 1 tablet each time, 3 times a day, for 2 consecutive weeks.

Sponsors

Zhangjiagang City Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Ages 18 to 65; Meets the diagnostic criteria for unilateral sudden sensorineural hearing loss (SSNHL); Time from onset of symptoms to enrollment does not exceed 14 days; Capable of completing audiological assessments, questionnaire evaluations, and signing an informed consent form.

Exclusion criteria

Exclusion criteria: Bilateral sensorineural hearing loss; Known causative hearing loss conditions, such as Meniere's disease, acoustic neuroma, middle ear diseases, noise damage or ototoxic drug-induced deafness; Severe heart, liver, kidney, mental or coagulation dysfunction; Pregnancy or lactation; Recent regular use of potent sedative-hypnotic drugs that may significantly affect sleep assessment; Night shift or long-term shift workers; Those who have received acupuncture treatment within the last 1 month; Those who are unable to complete treatment or follow-up as per the plan.

Design outcomes

Primary

MeasureTime frame
pure tone test;

Secondary

MeasureTime frame
Tinnitus matching;Speech recognition rate in noise;Tinnitus Disorder Scale;36 Short Health Questionnaires;Pittsburgh Sleep Quality Index Questionnaire;self-rating anxiety scale;insomnia severity index;

Countries

China

Contacts

Public ContactJiang Xiaoting

Zhangjiagang City Traditional Chinese Medicine Hospital

1245127527@qq.com18550133946

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026