Effect of Gomutra Arka Karnapoorana on Fungal growth of Otomycosis w. r. t Karnasrava - A Randomised Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reduction in fungal growth
研究概览
简要总结
Effect of Gomutra Arka Karnapoorana on Fungal growth of Otomycosis w. r. t Karnasrava - A Randomised Controlled Clinical Trial
Otomycosis is a common superficial fungal infection that affects the external auditory canal (EAC). The infection is present globally, with prevalence ranging from 9% to 30% in patients with the signs and symptoms of EAC infection. The most common causative agents of otomycosis are Molds of the genus Aspergillus and yeasts of the genus Candida, particularly Aspergillus (A.) Niger complex and Candida (C.) albicans. Intense itching, discomfort or pain in the ears, watery discharge with musty odour, reduced hearing and fungal mass are the main signs and symptoms of otomycosis. Treatment of otomycosis includes local therapy as Aural toileting and anti- fungal agents with steroid formulations. This line of treatment can revert the otomycosis which involves some potential side effects.The clinical features of otomycosis are similar to karnasrava explained in Ayurveda classics. Treatment protocol of Karnasraava includes shirovirechna, dhupana, purana, pramarjana, dhavana (Raajavrukshadigana ,Surasaadigana),avachurnana (manashila, lodhra) and Karanpurana .
In this study Gomutra arka, which has antifungal property is chosen for the karnapoorana. Arka taila karnapoorana is taken as control group.
Methodology: clinically diagnosed patients of otomycosis fulfilling inclusion criteria will be Randomly allocated to study groups using Computerised Randomization chart with informed consent. Patients allocated to Group A(Trial) will be treated using GomutraArka karnapoorana and Group B (Control) will be treated with Arka taila karnapoorana daily for 100 matra kaala(2.4mins) for 15 days with the interval of 5 days. Patients will be assessed on day 1,15,30 and 45 for itching scale, otalgia, otorrhia and fungal mass. Any ADR will be addressed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed cases of otomycosis
- •Willing to give consent.
排除标准
- •Patient with Otitis Media.
- •Other otitis externa.
- •Post-operative cases of ear surgery.
- •Structural ear anomalies that make assessment of therapeutic response difficult.
- •Uncontrolled diabetes mellitus and Hypertension
- •Known cases of other systemic illness
- •Pregnancy and lactating women
- •Patients using concomitant medicines that may interfere with the study evaluations.
结局指标
主要结局
Reduction in fungal growth
时间窗: 15 days
次要结局
- Reduction of itching in ear(15 days)
研究者
shashikala khadabadi
Shree jagadguru Gavisiddheshwara Ayurvedic medical collage and hospital