Clinical trial
RCT Study of Liuwei Dihuang Pill Preventing and Treating Presbycusis With Shen (Kidney)-Yin Deficiency
Name
RLDP-2021
Description
The objective of this study is to examine the effects and safety of Liuwei Dihuang pill and placebo in presbycusis with Shen (kidney)-yin deficiency.
Trial arms
Trial start
2022-01-24
Estimated PCD
2024-05-30
Trial end
2024-10-30
Status
Recruiting
Phase
Early phase I
Treatment
Liuwei Dihuang Pill (marketed product in China)
LDP group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo group and LDP group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the LDP group and placebo group at a ratio of 1:1. The drug was administered for 48 weeks, 3 times a day, 8 pills each time.
Arms:
LDP group
Other names:
Liu Wei Di Huang Pill
Liuwei Dihuang Pill（placebo ）
LDP group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo group and LDP group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the LDP group and placebo group at a ratio of 1:1. The drug was administered for 48 weeks, 3 times a day, 8 pills each time.
Arms:
placebo group
Other names:
placebo group
Size
120
Primary endpoint
Change in PB-Max after 48 weeks of treatment
48 weeks
Eligibility criteria
Inclusion Criteria:
1. Subjects must have a current diagnosis of presbyacusis with symmetrical hearing loss, defined as 15-dB or less difference in pure tone average between ears at 0.5, 1, 2 and 4kHz. The average hearing threshold loss level is mild or moderate (20 ≤ average hearing threshold \< 50 dBHL).
2. Adult aged 65-75 years inclusive.
3. Maximum speech recognition rate in quiet environment is equal to or over 60% with ability to communicate well.
4. Subjects have no cognitive impairment with CDR score =0.
5. Subjects must have a current diagnosis of Shen (Kidney)-Yin Deficiency.
6. Subjects have read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure.
Exclusion Criteria:
1. Subjects with sudden hearing loss or pure tone hearing fluctuation within the three months.
2. Subjects with a history of serious mental illness.
3. Subjects with severe cardiac insufficiency, malignant tumor or other serious systemic diseases.
4. Subjects with conductive deafness, congenital deafness, hereditary deafness, inner ear immune and autoimmune inner ear diseases, auditory neuropathy, toxic deafness and noise deafness.
5. Subjects with organic ear diseases, abnormal ear structure and symptomatic cerebral infarction.
6. Subjects with dementia, neurosyphilis, hypothyroidism and depression.
7. Subjects has previously participated in other clinical trial within the three months.
8. Subjects with using hearing aids or devices.
9. Other situations where the researcher thinks it is inappropriate to participate in this research.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study of Liuwei Dihuang Pill Administered by taking orally in Adults With Presbycusis With Shen (Kidney)-Yin Deficiency.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2023-08-09
1 organization
1 product
3 indications
Organization
Shanghai Jiao Tong University School of MedicineProduct
Liuwei Dihuang PillIndication
PresbycusisIndication
Age-related Hearing LossIndication
Hearing Disorders and Deafness