跳至主要内容
临床试验/CTRI/2024/06/068877
CTRI/2024/06/068877尚未招募2/3 期

Evaluation of efficacy of Patola-Katurohinyadi Ghana vati and Panchavalkaladi mouthwash in the management of Tundikeri (Tonsillitis)-An Open labelled two arm Randomised Contolled Trial

All India Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月25日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
1.Changes in Sign and Symptoms of Tundikeri i.e.Congestion and Dysphagia

研究概览

简要总结

Tonsillitis or inflammation of the tonsils is a common disease and makes up appx. 1.3% of outpatient visits.  It is rare in infants and in persons who are above 50 years of age.(1)

It may be viral or bacterial. Clinical features are sore throat, dysphagia, earache, hyperemia of pillars, soft palate, and uvula, enlarged and tender cervical lymph nodes, pyrexia, etc. The treatment may include plenty of fluids, analgesics, and antimicrobial therapy. If not managed properly and on time, may lead to chronic tonsillitis, peritonsillar abscess, cervical abscess, acute otitis media, etc.

Chronic tonsillitis may be a complication of acute tonsillitis. Mostly it affects children and young adults and rarely occurs after 50 years. Chronic infection in sinuses or teeth may be a predisposing factor (2). The Clinical features include recurrent attacks of sore throat with the cough, halitosis, dysphagia, and choking spells at night. Conservative treatment consists of orientation to general health with treatment of co-existent factors of teeth, nose, and sinuses. Tonsillectomy is indicated when tonsils interfere with speech, deglutination, and respiration(3).

 The clinical features of Tundikeri explained in the classics are similar to Tonsillitis.. Acharya Shushruta considered Tundikeri as Talugata Roga and Acharya Vagbhatt mentioned it in Kanthagata Roga under the heading of Mukha Roga. Tundikeri is due to vitiation of Kapha-Rakta ,there is manifestation of Shopha near Talu or Hanusandhi which resemble like Karpasa Phala and having  characteristics like Shotha,Toda, Daha,Prapaka, Pichhila, Mandaruja etc .All drugs should have properties like Lekhana, Shothhara, Sandhaniya, Ropana, Rakt stambhaka and Vedana sthapana..

 Patoladi gana is mentioned in Ashtang hridya in Shodhanadi Gana sanghrah adhyay which consists of Patola, Katurohini, Madhusrav, Chandana, Guduchi, and Patha (4). Almost all ingredients are rakta-prasadak kapha, pittaghna. Ghana vati is made  to mask the distaste. This ghana vati is easy to administer. Few works have been done on various aspects of Tundikeri, no study have been found  on  Patola katurohinyadi ghana vati. Thus an attempt has been made attempt to study its efficacy in Tundikeri .

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
10.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • patients having signs and symptoms of tundikeri,patients aged between 10-40 years, patients who are willing to participate in the study.

排除标准

  • patient with complications of Tonsillitis like Peritonsillar abscess, parapharyngeal abscess,Malignancy, Syphilis, and TB presenting as tonsillar disease.
  • Immuno-compromised patients like HIV, SLE, multiple myeloma, Cancer etc.
  • Patients having systemic diseases like diabetes, hypertension, thyroid dysfunction.

结局指标

主要结局

1.Changes in Sign and Symptoms of Tundikeri i.e.Congestion and Dysphagia

时间窗: 42 days

次要结局

  • Changes in sign and symptoms of Tundikeri (Tonsillitis) i.e Fever, Pain, Size of tonsils,burning sensation, halitosis,white pus filled follicles on tonsils, lymph node enlargement. Changes in haematological parameters(42 days)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Priyanka Yadav

All India Institute of Ayurveda

研究点 (1)

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