An Open Labelled Randomized Clinical Trial To Evaluate Asana Bilwadi Taila Shirobasti, Nasya And Karnapoorana In Karnakshweda With Special Reference To Tinnitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Asana Bilwadi Taila Shirobasti, Nasya and Karnapoorana are effective in the management of Karnakshweda w.s.r.(Tinnitus)
研究概览
简要总结
This was an open labelled randomized trial
Purpose – To Prove the effectiveness of Asana -Bilwadi Taila Shirobasti and Asana-Bilwadi Nasya and Karnapoorana in the management of Karnakshwda w.s.r. (Tinnitus).
Drug: Asana-Bilwadi Taila
Group A – Shirobasti
Total Duration: 14 days and 10,000 Matra(53 minutes approx)
Group B- Nasya & Karnapoorana
Nasya: 6-8 drops
Karnapoorana: 10-12 drops in each ear canal
Total Duration: 14 days divided in 2 sittings with 1week gap.
Follow up was taken after completion of therapies on 15th, 30th and 45th day
CONCLUSIONS:
1. A very detailed accountof Karnakshweda as a Swantantra Roga and Lakshana is foundin the classics of Ayurveda.
2. Tinnitus is the closestmodern counterpart of Karnakshweda and these are disorders of CNS andauditory nerve origin.
3. Tinnitus has worldwideprevalence and can affect a person of any gender belonging to any age-groupageno.
4. Tinnitus can be veryintrusive and may cause difficulty with sleep and concentration and a decreasedability to participate in everyday activities and social events.
5. With growing levels ofstress and noise pollution the incidences of tinnitus are also increasing.
6. The prevalence was foundmore in the people of active nature of work proving that Shrama is an important Nidana in the pathogenesis of Karnakshweda.
7. Majority of the patientshad Vata-Pitta Prakriti which was inaccordance of the Jangala Desha ofthe place of study.
8. Most of the patientsi.e. 62.5% patients complained of bilateral tinnitus, it can be said that dueto the Balwana Swabhava of Vyadhi due to Tridosha and Rakta involvementit acquires both the Adhisthanas of Shravanendriya.
9. The study shows thatboth the therapies were effective in treating the Lakshanas of Karnakshweda basedon the subjective criteria i.e. for both of the groups p-value<0.05 henceboth treatments were significant but in Group-B Nasya and Karnapooranawere found to be effective in Badhirya basedon the objective criteria with p-value<0.05 hence considered as significant.
10. On statistical analysisit was found that there was nosignificant difference between both the groups.
11. The finished productdrug analysis proved Asana-Bilwadi Tailato be safe and non-toxic, the rancidity value was 0 indicating high shelf lifewith no microbe growth.
12. No adverse effects orincidental findings were observed during and after trial.
13. Concisely Ayurvedamodalities and drug proved to be safe and effective in the management of Karnakshweda.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 8.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients presenting with sign and symptoms of Karnakshweda described as per ayurvedic text and modern parlance.
- •2.Patients having tinnitus due to Otosclerosis.
- •3.Patients having tinnitus noise induced.
- •5..Patients having tinnitus associated with sensorineural hearing loss.
排除标准
- •Patients aged below eight years and above eighty years will be excluded.
- •Patients presenting with tympanic membrane perforation.
- •Otological surgery within the past year.
- •Patients presenting with congenital deformities 5.
结局指标
主要结局
Asana Bilwadi Taila Shirobasti, Nasya and Karnapoorana are effective in the management of Karnakshweda w.s.r.(Tinnitus)
时间窗: 15th day after completion of procedures. | 30th day after completion of procedures. | 45th day after completion of procedures.
次要结局
- Kriyakalpa procedures might be effective in the following conditions:(1.Keshshata(Pattern hair loss))