Effect of Triphala Kashaya with Tankana Kshara as Kabala compared to Saline water gargling in Acute Tonsillitis in the age group of 8-25 years A Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- FRIEDMAN GRADING SCALE
研究概览
简要总结
Acute Tonsillitis is the inflammation of the tonsils, mainly attributed to viral/bacterial
infections in which the predisposing factors are primary infection of tonsils /secondary
to upper respiratory tract infections, poor oro dental hygiene and weakened immunity
and commonly affects children and young individuals between the ages of 5 and 18,
and is rarely seen in people over 50 years old. Symptoms includes Congested Swollen
tonsils, Sore throat, Throat Pain while swallowing, fever(38-40 c) with chills and rigors,
earache, enlarged jugulo-digastric lymph nodes and constitutional symptoms such as
headache, general body aches ,constipation. Standard management often includes
antimicrobial therapy, adjunctive treatments such as gargling solutions are commonly
used for symptomatic relief.
Considering the signs and symptoms of Acute Tonsillitis it can be correlated to
Tundikeri in ayurveda described under mukharoga which has predominance of kapha
and rakthadoshas.Tundikeri chikitsa involves Pratisarana, kabala, dhoomapana,
vamana, raktamokshana, gandusha and pradhamana nasya.In this treatment
modalities, Sodhana kabala is safe and best for pacifying the vitiated kapha doshas
,predominant doshas in the mukharoga and this study is planned to compare the
effective of Triphala Kashaya with Tankana Kshara as Kabala against saline water
gargling in the treatment of acute tonsillitis.
A comparative clinical trial with 40 Subjects satisfying inclusion criteria will be
assigned into the two Groups A and B and will be administered Triphala kashaya with
Tankana kshara and saline water gargling respectively along with Amruthotharam
kashayam internally for both groups. The effect of both interventions can be assessed
by Friedman’s grading scale, symptomatic grading scores , Photography of tonsils and
Throat swab culture evaluated from the baseline, on the 7
th day and follow up on 15th
day. Results will be statistically analysed after the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 8.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with at least any one of the symptoms presenting with clinical manifestations of Acute Tonsillitis such as Throat Pain, Inflammed tonsils (which occupies up to 50% of oropharyngeal width, the tonsil doesn’t go beyond the tonsillar pillars), Sore throat, Dysphagia
- •Participants who has tonsillar enlargement resulting with odynophagia and history of fever is included.
- •Subjects who are indicated for kabala procedure.
- •Subjects who are willing to give an informed written consent form and an assent form.
排除标准
- •Participants suffering from other systemic illness and associated with any malignancies.
- •Participants who are suffering from Bulbar palsy, Facial palsy and those who cannot follow instructions.
- •Participants with complications of Acute tonsillitis such as Peritonsillar abscess, Parapharyngeal abscess, Acute otitis media, Otalgia, Acute nephritis, Chronic nephritis, Rheumatic fever.
- •Subjects who are known for suspected allergic reactions to any study medication.
- •Subjects who are frequently taking Inhalers, Oxygen therapy.
- •Subjects who are allergic to Lignocaine.
结局指标
主要结局
FRIEDMAN GRADING SCALE
时间窗: 0th, 7th and 15th day
• SYMPTOMATIC GRADING SCORE
时间窗: 0th, 7th and 15th day
• Patient diary.
时间窗: 0th, 7th and 15th day
OBJECTIVE PARAMETER
时间窗: 0th, 7th and 15th day
• Photography of tonsils of participants before and after the treatment period.
时间窗: 0th, 7th and 15th day
次要结局
- Throat swab culture(0th and 7th day)
研究者
KRISHNENDU T D
GOVERNMENT AYURVEDA COLLEGE KANNUR