An open lablled single arm clinical study to evaluate the efficacy of Tila Taila in the management of KARNAGOOTHA with special reference to IMPACTED EAR EAX
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Parameters
研究概览
简要总结
NEED OF THE STUDY:
Karnagootha is one among Karnarogas. It can be correlated with impacted earwax or Cerumen can lead to symptoms such as hearing loss, tinnitus, pain, itching and vertigo.
Cerumen or ear wax is a mixture of the glandular secretions from the lateral third of the ear canal and exfoliated squamous epithelium. It lubricates the ear canal, acts as a trap for dust, hair and insects. Normally cerumen is eliminated or expelled by self-cleansing mechanism which causes it to migrate out of the ear canal assisted by jaw movements.
Taila prakledana has been mentioned classically as the first stage of Karnagootha Chikitsa.Tila taila is the best choice of drug due to its Vatakaphaharatva, Snigdha, Sukshma, Tikshna and Ushna properties, which can help in Kledana and Shodhana of Karnagootha.
Very few studies have been done with respect to management of Karnagootha (impacted wax). Among them published researches are still minimum.
Hence, an effort has been made in this present single armed clinical study to evaluate the efficacy of Tila taila in the management of Karnagootha.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects presenting with the classical features of Impacted ear wax.
- •2.Subjects within the age of 21 to 60 years irrespective of gender, occupation, religion, socio-economic status and duration of illness.
- •3.Subjects willing to sign informed consent.
排除标准
- •1.Subjects suffering from Otitis externa 2.Subjects suffering from Otomycosis 3.Subjects suffering from CSOM and ASOM 4.Subjects suffering from Tympanic Membrane Perforation, 5.Any other Inflammation and space occupying lesions of EAC.
结局指标
主要结局
Objective Parameters
时间窗: •Before treatment -0th day | •After treatment – 6th day | •1st Follow up – 10th day | •2nd Follow up - 15th day
•Tuning fork test (Rinne’s test – 512Hz)
时间窗: •Before treatment -0th day | •After treatment – 6th day | •1st Follow up – 10th day | •2nd Follow up - 15th day
•Aural Endoscope
时间窗: •Before treatment -0th day | •After treatment – 6th day | •1st Follow up – 10th day | •2nd Follow up - 15th day
次要结局
- •Ear pain(•Itching in the Ear)