Therapeutic Effect of Intra-Tympanic Methyl Prednisone-platelet Rich Plasma Combination in Sensorineural Hearing Loss and Tinnitus of Cochlear Origin.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Improvement in Hearing
研究概览
简要总结
Steroids are used widely for the treatment of Sensorineural hearing loss worldwide. The difficulty lies with efficient delivery of the drug into the cochlea, which is already a sealed chamber with limited blood supply that too with an end Artery. We intend to extrapolate its effects by combining it with Platelet rich plasma. intra-tympanic delivery is achieved with injection via tympanic membrane and its absorption via round window is hastened by posture maintenance for about half an hour. PRP is an autologous biologic fluid which has excellent safety profile and is already in use by various specialties.
详细描述
Definitions:
Sensorineural Hearing Loss: Hearing loss occurring due to pathologies of cochlea.
Platelet-rich plasma : Platelet-rich plasma is an autologous biological product separated from blood after removal of Red blood cells. It is the plasma portion of blood which is simply rich of platelets.
Preparations:
Intratympanic methyl prednisone + Autologous PRP: 2ml Solution (1ml of methyl prednisone 40mg/ml + 1ml of PRP)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Care giver and patient both are known to the treatment being offered under investigation.
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 10-70 yrs
- •Capacity to have a Pure tone Audiometry test
- •Unilateral or bilateral sensorineural hearing loss
- •Without any identifiable cause
- •Subjective sensation of noise without any obvious source of sound
- •Without any identifiable cause
- •Hearing levels of 55dB or above
排除标准
- •Age: less than 10 or more than 70 yrs
- •Conductive hearing loss/ Mixed Hearing loss
- •Tumor, Neurologic cause of hearing loss/ tinnitus
- •Past ear Surgery
- •Any External, middle or inner Ear Disease other than SSNHL
- •Traumatic Hearing Loss or Hearing Loss due to an obvious cause.
- •Patients' refusal to follow-up
- •Any contraindication to Steroids administration.
- •Any Blood Disorder
- •Non-consenting patients
- •Comorbid:
- •Hypertension
- •Cardio vascular diseases
研究组 & 干预措施
Single Treated Arm
Single arm study, Patients with SNHL and Tinnitus all were given same Composite solution consisting of (Methyl prednisone and Platelet rich plasma) via intr-atympanic route..
干预措施: Combination Solution (Drug)
结局指标
主要结局
Improvement in Hearing
时间窗: 2 weeks post treatment completion.
Improvement in hearing as per Audiogram, measured in decibels.
Improvement in Tinnitus
时间窗: 2 weeks post treatment completion.
Improvement in Tinnitus as per Visual analogue scale from 1 to 10 with 1 being the lowest improvement and 10 being the best.
次要结局
未报告次要终点
研究者
Muhammad Noman Karim
Principal Investigator, Otolaryngology Dept, CMH Rawalpindi
CMH RWP Combined Military Hospital RWP: Rawalpindi