Sudden Hearing LossNCT07505667
Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss
A study testing Standard treatment combined with Yiyuancong and Standard treatment in people with Sudden Hearing Loss and Sensorineural Hearing Loss, run by Guangdong Provincial People's Hospital at 5 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sudden Hearing Loss, Sensorineural Hearing Loss
- What is being tested?
- Standard treatment combined with Yiyuancong and Standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 5 sitesChina
- Study dates
- 15 Nov 2025to 15 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral sudden sensorineural hearing loss (SSNHL) occurring within 72 hours, with a hearing threshold decrease of 20 dB at at least two consecutive frequencies.
- Enrollment must be completed within 14 days of the onset of SSNHL.
- Males or females aged 18 to 60 years.
- Ability to understand the study protocol and comply with regular follow-up visits.
Who cannot join
- Pregnancy or lactation (breastfeeding).
- History of chronic ear disease, prior ear surgery, autoimmune hearing loss, or a confirmed diagnosis of Meniere's disease.
- Receipt of corticosteroid therapy for any reason within the previous 30 days.
- Presence of autoimmune diseases or chronic inflammatory diseases.
- Severe hepatic or renal impairment.
- Any other condition that, in the opinion of the investigator, renders the participant unsuitable for inclusion.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Guangdong Provincial People's Hospital Ganzhou Hospital
Ganzhou, Jiangxi
ZhuoYi Chen MD, +86 18737552662, 18737552662@163.com
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
ZhuoYi Chen MD, +86 18737552662, 18737552662@163.com
- Recruiting
Liuzhou Worker's Hospital
Liuzhou, Guangxi
ZhuoYi Chen MD, +86 18737552662, 18737552662@163.com
- Recruiting
Shenzhen Baoan People's Hospital
Shenzhen, Guangdong
ZhuoYi Chen MD, +86 18737552662, 18737552662@163.com
- Recruiting
Xiaolan People's Hospital of Zhongshan
Zhongshan, Guangdong
ZhuoYi Chen MD, +86 18737552662, 18737552662@163.com
About this study
Official title: Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss: A Multicenter, Randomized, Controlled Trial
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).
- Conditions
- Sudden Hearing Loss, Sensorineural Hearing Loss
- Being tested
- Standard treatment combined with Yiyuancong, Standard treatment
- Medical subject headings
- Hearing Loss, Sudden, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatment combined with YiyuancongDrug
Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals
Standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals | Experimental | Not described Receives: Drug: Standard treatment combined with Yiyuancong |
| Standard treatment | Active comparator | Not described Receives: Drug: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pure-Tone Audiometry Hearing Threshold (dB HL)
Change in hearing threshold levels measured in decibels hearing level (dB HL) across standard audiometric frequencies (0.25-8 kHz) using calibrated pure-tone audiometry. Lower dB HL values indicate improved auditory sensitivity.
Measured: baseline (day of enrollment), and Day 7, Month 1, and Month 2 post-treatment.
Secondary outcomes (6)
Speech Recognition Score (Word Recognition Percentage)
Speech recognition ability measured using standardized word recognition testing (e.g., NU-6 word lists). Scores range from 0-100%, with higher scores indicating better speech discrimination ability.
Measured: baseline, and Day 7, Month 1, and Month 2 post-treatment.
complete blood count (CBC)
Measured: baseline, and Day 7, Month 1, and Month 2 post-treatment.
Haematological index on kidney function
The investigators assess the changes in haematological index on kidney function levels compared to the baseline. The indicators for evaluating kidney function include biochemical parameters such as serum creatinine, urea nitrogen, uric acid, glomerular filtration rate, and urine protein.
Measured: baseline, Month 1, and Month 2 post-treatment.
Haematological index on liver function
The investigators assess the changes in haematological index on liver function and kidney function levels compared to the baseline. The indicators for evaluating liver function include biochemical indicators such as albumin, transaminases, and bilirubin.
Measured: baseline, Month 1, and Month 2 post-treatment.
Fecal composition analysis
16S rDNA sequencing and bioinformatic analysis were performed on fecal samples collected before and after treatment to identify significantly altered gut microbiota. By comparing microbial diversity, abundance, and function across these time points, the regulatory effects of the Yiyuancong compound on the intestinal microecology were preliminarily explored
Measured: baseline, and Month 2 post-treatment.
Peripheral venous blood composition analysis
Liquid chromatography-mass spectrometry (LC-MS) was employed to perform qualitative and quantitative analysis of the active constituents and metabolites in the patients' plasma. By integrating the results of metabolomics and transcriptomics, the primary active components and potential biological targets of the Yiyuancong compound were further validated.
Measured: Baseline, Month 1 and Month 2 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start15 Nov 2025
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Hearing LossStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiong hao, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505667
- Sponsor's protocol ID
- KY2026-115-01
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss: A Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07505667
- Acronym / sponsor ID
- KY2026-115-01
- Conditions
- Sudden Hearing Loss, Sensorineural Hearing Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals | Experimental | Drug: Standard treatment combined with Yiyuancong |
| Standard treatment | Active comparator | Drug: Standard treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Unilateral sudden sensorineural hearing loss (SSNHL) occurring within 72 hours, with a hearing threshold decrease of 20 dB at at least two consecutive frequencies.
- Enrollment must be completed within 14 days of the onset of SSNHL.
- Males or females aged 18 to 60 years.
- Ability to understand the study protocol and comply with regular follow-up visits.
Key exclusion criteria (6 listed)
- Pregnancy or lactation (breastfeeding).
- History of chronic ear disease, prior ear surgery, autoimmune hearing loss, or a confirmed diagnosis of Meniere's disease.
- Receipt of corticosteroid therapy for any reason within the previous 30 days.
- Presence of autoimmune diseases or chronic inflammatory diseases.
- Severe hepatic or renal impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard treatment combined with YiyuancongStandard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals | Drug | Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals |
| Standard treatmentStandard treatment | Drug | Standard treatment |
Primary outcome
Change in Pure-Tone Audiometry Hearing Threshold (dB HL)
Time frame: baseline (day of enrollment), and Day 7, Month 1, and Month 2 post-treatment.
Change in hearing threshold levels measured in decibels hearing level (dB HL) across standard audiometric frequencies (0.25-8 kHz) using calibrated pure-tone audiometry. Lower dB HL values indicate improved auditory sensitivity.
6 secondary outcomes
Speech Recognition Score (Word Recognition Percentage)
Time frame: baseline, and Day 7, Month 1, and Month 2 post-treatment.
complete blood count (CBC)
Time frame: baseline, and Day 7, Month 1, and Month 2 post-treatment.
Haematological index on kidney function
Time frame: baseline, Month 1, and Month 2 post-treatment.
Haematological index on liver function
Time frame: baseline, Month 1, and Month 2 post-treatment.
Fecal composition analysis
Time frame: baseline, and Month 2 post-treatment.
Peripheral venous blood composition analysis
Time frame: Baseline, Month 1 and Month 2 post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard treatment combined with Yiyuancong and Standard treatment in people with Sudden Hearing Loss and Sensorineural Hearing Loss, run by Guangdong Provincial People's Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhuoyi Chen MD (+86 18737552662, 18737552662@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pure-Tone Audiometry Hearing Threshold (dB HL) (time frame: baseline (day of enrollment), and Day 7, Month 1, and Month 2 post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.