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NCT07505667
Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss
NA trial testing Standard treatment combined with Yiyuancong in Sudden Hearing Loss in 128 participants. Currently enrolling.
15 November 2027
Quick facts
| Lead sponsor | Guangdong Provincial People's Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 128 |
| Start date | 15 November 2025 |
| Primary completion | 15 November 2027 |
| Estimated completion | 15 November 2027 |
| Sites | 5 locations across China |
Drugs / interventions tested
- Standard treatment combined with Yiyuancong
- Standard treatment
Conditions studied
- Sudden Hearing Loss — all drugs for Sudden Hearing Loss →
- Sensorineural Hearing Loss — all drugs for Sensorineural Hearing Loss →
Sponsor
Guangdong Provincial People's Hospital
Who can join
Adults 18 to 60, any sex, with Sudden Hearing Loss or Sensorineural Hearing Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This project aims to evaluate the clinical efficacy of Yiyuancong, an independently developed traditional Chinese medicine (TCM) formula based on the homology of medicine and food, in participants with sudden sensorineural hearing loss (SSNHL) and to elucidate its potential underlying mechanisms. This study is designed as a multicenter, randomized controlled trial (RCT), utilizing dynamic randomization for participant allocation. Due to the requirement for the experimental group to continuously administer the TCM preparation for 1-2 months, this study is conducted as an open-label (non-blinded) trial. All participants will undergo audiological evaluations at baseline, day 7 of treatment, and upon completion of the first and second treatment courses. Based on previous research regarding integrated traditional Chinese and Western medicine for SSNHL, the estimated effect size (ES) for the improvement of pure-tone thresholds compared with Western medicine alone ranges from 0.5 to 0.8. Assuming an effect size of 0.5 for the difference in pure-tone audiometry (PTA) improvement between the experimental and control groups, with a significance level (α) of 0.05 (one-tailed) and a statistical power (1-β) of 0.8, the required sample size calculated via G\*Power software is 51 per group. Accounting for a 20% dropout rate, the investigators plan to enroll 64 participants per group (total N = 128).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other recruiting trials for Sudden Hearing Loss
Currently open trials in the same condition.
- NCT07235488 — Effectiveness of Integrative Medical Treatment in Sudden Hearing Loss · NA · recruiting
- NCT05474963 — Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital · recruiting
Other Guangdong Provincial People's Hospital trials
Trials by the same sponsor.
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- NCT07352930 — A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Can · NA · not yet recruiting
- NCT07472478 — Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12 · Phase 2 · not yet recruiting
- NCT07483398 — RELIEF-PD: Crisugabalin for Nociplastic Pain in Parkinson's Disease · Phase 4 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07505667 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Guangdong Provincial People's Hospital
- Last refreshed: 1 April 2026
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