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临床试验/CTRI/2023/04/051863
CTRI/2023/04/051863尚未招募4 期

A controlled clinical study to evaluate the effect of tilanala kshara pratisarana in tundikeri(chronic tonsillitis)

Department Of Shalakya Tantra1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月5日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To observe the reduction in enlarged tonsils and pain

研究概览

简要总结

Tundikeriis a Mukharoga categorized under Taluroga1 by Sushrutaand Kantha roga by Vagbhata where he compares it to vana karpasa phala2.It is caused due to vitiation of Kapha and Rakta dosha and it ischaracterized by Jwara (fever), toda(pricking pain), daha (burning), shopha (inflammation) andprapaki (suppuration) in talupradesha3. The samanyachikitsa in Tundikeri includes pratisarana, chedana karma,kavalagraha and dhumapana4. This can be correlated totonsillitis.

Tonsils are muco-lymphoid tissues situated inoro-pharynx at the gateway of oro-pharyngeal route and considered as one of thechief immuno component tissues. Thus more prone to get infection from nasalroute as well as oral route and become hypertrophic, this inflammation causestonsillitis. It is characterizedby pricking pain, sore throat, cough, halitosis and dysphagia. The prevalenceof tonsillitis in adults was formulated approximately, 77% female are affectedwith tonsillitis than 22.9% of male. Among the responders, 75% have tonsillitisand remaining 25% doesn’t have tonsillitis5. It is treated byanalgesics like Paracetamol, Aceclofenac and Anti-Microbial drugs like Amoxicillin potassium clavulanate,Azithromycin. In chronic cases Tonsillectomy6 is recommended.Frequent episodes of the infection interfere with normal growth and developmentof the child. Due to incomplete treatment or resistance of organisms toantibiotics, tonsillitis can reach chronic stage. It has common side effects inchildren like nausea, headache, abdominal pain, diarrhea, gastric upset7.

In chronic tonsillitis as there ishypertrophy of the tonsillar tissue is present, which can be considered as adhimamsa and according to acharya charaka ‘ksharo Arbuda adhimamseshu kriya’…||8 the line oftreatment is Kshara application. Pratisaraneeya Kshara acts on hypertrophiedtonsils by cauterization of mass because of its corrosive nature. Thus producesshrinking effect on tonsillar hypertrophy.

In Tundikeri Pratisaraneeya kshara is one of the treatment protocol,which does chedana, bhedana, lekhana and it is safe procedure in the conditionof chronic tonsillitis with enlarged tonsils where tonsillectomy is not reallyrequired. Tilanala kshara is one among the ksharaastaka9,10and  having katu, tikta rasa, Sukshma,vyavayi guna and usna veerya. Hence Tilanala kshara pratisaranais taken out as trial group in the management of Tundikeri with Apamargakshara pratisarana as a controlled group.

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 40.00 Year(s)(—)
性别
All

入选标准

  • •1 Patients having the symptoms of chronic tonsillitis (Tundikeri).

排除标准

  • •1 Tonsillitis with cardinal signs like peritonsillar abscess, parapharyngeal abscess, intra tonsillar abscess.
  • •2 Conditions like Diphtheria, Tonsiloliths which mimic Tonsillitis.
  • •3 Patients with Systemic diseases that needs long treatment.
  • •4 Pregnant women and lactating mothers.

结局指标

主要结局

To observe the reduction in enlarged tonsils and pain

时间窗: 7 days

次要结局

  • To observe the amount of reduction in dysphagia, congestion and sore throat(21 days)

研究者

发起方
Department Of Shalakya Tantra
申办方类型
Research institution and hospital

研究点 (1)

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