A randomized open label controlled clinical study to evaluate the efficacy of Shatadhauta Ghrita Karnapichu in the management of Pittaja Karnashula with special reference to Otitis Externa
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Significant improvement in the signs and symptoms of Pittaja Karnashoola.
研究概览
简要总结
Pittaja Karnashoola is one such condition where vitiation of Pitta and Vata is seen, which causes severe pain and is intolerable to an individual.
The symptoms of Pittaja Karnashoola can be considered as an inflammatory disorder of the external ear, Otitis externa.
The prevalence of the condition Otitis externa is 17.5% in the developing countries. Also, it has a lifetime prevalence of 10% and can arise in acute, chronic or necrotizing forms.
It is common all over the world with higher incidence in tropical than in temperate zones. Most commonly it affects adults. The incidence is increased fivefold in swimmers; thus, this condition is also called as swimmer’s ear.
In contemporary science, the treatment of Otitis externa includes systemic antibiotics, analgesics and an aural pack with 10% ichthammol glycerine or with steroid antibiotic.
In Ayurveda, Karnapoorana has been mentioned as one of the treatment modality in Pittaja Karnashoola with Pittahara Dravyas.
RESEARCH QUESTION:
•Whether Shatadhauta Ghrita Karnapichu is effective in the management of Pittaja Karnashoola w.s.r to Otitis externa?
HYPOTHESIS:
Null Hypothesis (H0): There is no significant difference between Shatadhauta Ghrita Karnapichu and Yashtimadhu Ghrita Karnapichu in the management of Pittaja Karnashoola w.s.r to Otitis externa.
Alternative Hypothesis (H1): Efficacy of Shatadhauta Ghrita Karnapichu is more effective than that of Yashtimadhu Ghrita Karnapichu in the management of Pittaja Karnashoola w.s.r to Otitis externa.
Alternative Hypothesis (H2): Efficacy of Yashtimadhu Ghrita Karnapichu is more effective than that of Shatadhauta Ghrita Karnapichu in the management of Pittaja Karnashoola w.s.r to Otitis externa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects within the age of 21-40 years irrespective of gender, occupation, religion, socio- economic status and duration of illness.
- •2.Subjects fulfilling the diagnostic criteria.
- •3.Subjects willing to undergo trial and sign the informed consent.
排除标准
- •1.Subjects diagnosed with disorders of auricle.
- •2.Subjects diagnosed with infective cases of the tympanic membrane and middle ear like acute suppurative otitis media, active stage of chronic suppurative otitis media.
- •3.Subjects diagnosed with cholesteatoma.
结局指标
主要结局
1.Significant improvement in the signs and symptoms of Pittaja Karnashoola.
时间窗: Pre-assessment- 0th day | Post-assessment- 6th day | 1st follow up- 14th day | 2nd follow up-21st day
2.Significant improvement in the signs and symptoms of Otitis externa.
时间窗: Pre-assessment- 0th day | Post-assessment- 6th day | 1st follow up- 14th day | 2nd follow up-21st day
次要结局
- 1.Generation of in - depth analysed data on the different aspect of the disease.(2.Generation of data on possible unexpected drug reaction.)
研究者
Dr Shivani C Kottur
Sri Sri College Of Ayurvedic Science And Research Hospital