跳至主要内容
临床试验/CTRI/2025/09/094736
CTRI/2025/09/094736尚未招募Phase 3 4

An open labelled clinical trial to evaluate the combined effect of Apamarga Kshara Pratisarana with Vachadi Kwatha Kavala and Kaishora Guggulu in Tundikeri with special reference to chronic tonsillitis in children.”

Dr amarnath dunage1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月15日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To evaluate the combined effect of Apamarga Kshara Pratisarana with Vachadi Kwatha Kavala &

研究概览

简要总结

The treatment principles of Ayurveda aim at eliminating the impurities. Kaumarabhritya, one among

the Ashtanga’s of Ayurveda exclusively deals with the child care both preventive and curative. As the

definition of Bala signifies, vulnerability of children to acquire disease is more when compared to an

adult.

A disease Tundikeri, explained by Ancient Ayurvedic classics under Mukhagata rogas lI7 and

Talugata Rogas |3455,71 appearing as a SthanikaShotha (local swelling) is one such disease in children,

caused due to an excess consumption of Guru, Snigdha, Amla and Abhishyandi Ahara’s leading to

Kapha, Pitta and Rakta Dusti. The Lakshanas of the disease Tundikeri mentioned in Ayurveda classics

are characterized by Sthoolashotha (hard swelling), Toda (pricking type of pain), Daha (burning

sensation), Prapaki (tend to undergo suppuration) and Avrodha (creates obstruction in throat for

respiration and deglutition) (SI. Acharya mentioned line of management of Tundikeri in Ayurveda similar

to that of Galashundika which include Shastra karma, Pratisarana, Kavala, Dhuma and use of Yushal°

According to Acharyas, common line of management of Kantharogas is also applicable to Tundikeri.

Thisinclude Kayshirovirechana, Vamana, Katu Tikta Kavala Graha, Raktavisravana, Kapharaktahara

Karma, Raktamokshana, Tikshna nasya, Pratisarana or Kavala, Lepana(101

Immunological protection of a newborn will be done by maternal antibodies and developed naturally

later in life through infection or artificially by immunization. Their inherent immunity diminishes within

months After birth. Whenever there is an infection in the oral cavity or respiratory tract, the tonsils act as

sentinels to guard against foreign intruders like viruses, bacteria and other antigens coming into contact

through inhalation and ingestion (’"I

Chronic tonsillitis in children may be described as a sore throat for 3 months or more, associated

with inflammation of the tonsils, presenting with features like chronic sore throat, halitosis, a foreign

body sensation in the throat, or a history of expelling smelly foul-tasting cheesy lumps 11Z. It profoundly

affects the child’s quality of life, having an impact on their ability to work, sleep, and enjoy daily

activities, leading to an inevitable school absence.If medicinal treatments are unsuccessful, then the final

option is to undergo a tonsillectomy surgery in those patients who have had sequelae, such as

peritonsillar abscess, lemierre syndrome, minimum frequency of sore throat episodes 7 or more in the

preceding year, cervical lymphadenopathy, tonsillar exudates, sleep apnea due to tonsillar hypertrophy

[13)

When considering tonsillectomy surgery, the surgery is associated with risks, can potentially pose

serious risks to a child’s health. The persistent inflammation and infection of the tonsils can lead to

complications that could become life threatening if not addressed. acute respiratory infections are a major

cause of children in India. Outpatient attendance attributed to acute respiratory infections is as high as

2040% of all outpatients and 12-35% of in patients.

Hence, an effective line of management intending to scrape out the inflamed cells with the retention

of surrounding normal tissues in chronic tonsillitis is a need of hour, so that the faster healing with less

or no recurrence of incidences will be achieved by the following treatment. Treatment with oral medication like Kaishora Guggulu along with various local drug application

methods like Apamarga Kshara Pratisarana, and Gargling with Vachadi Kwatha Kavala.

As Apamarga Kshara, known for its ushna (hot) and Tikshna (sharp) properties, plays a crucial role

in managing Tundikeri. It readily burns inflamed cells, aids wound cleansing, and accelerates healing by

promoting both vrana shodhana (cleansing of wounds) and Ropana (healing) (14)

Additionally, Vachadi Kwatha Kavala is effective in treating GalashundikaRoga which is similar to

Tundikeri within the context of Taluroga Chikitsal’5). Furthermore, Kaishora Guggulu is beneficial for

addressing conditions such as Mandagni, Kasa, Shwasa, and Shothall

Therefore, the present study is planned to evaluate the combined effect of Apamarga Kshara

Pratisarana with VachadiKwatha Kavala and Kaishora Guggulu in Tundikeri w.s.r to chronic Tonsillitis

in children.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children aged between 5 to 12 years.
  • Children fulfilling the diagnostic criteria with or without 1 or more symptoms of Pricking pain(Toda),Burning sensation (Daha), Suppuration (Paka), Recurrent or persistent sore throat, Irritation of throat, Halitosis, Sensation of obstruction of food in throat.

排除标准

  • Children with syndromic or other systemic illness with or without medication.
  • Children with acute exacerbation of chronic tonsillitis, sinusitis, ear infection, fever etc.
  • Children presenting with complications of tonsillitis.

结局指标

主要结局

To evaluate the combined effect of Apamarga Kshara Pratisarana with Vachadi Kwatha Kavala &

时间窗: To evaluate the combined effect of Apamarga Kshara Pratisarana with Vachadi Kwatha Kavala and | Kaishora Guggulu in symptomatic reduction of chronic tonsillitis in children | Duration 21 days | Follow up after 7 days | Total - 28 days

Kaishora Guggulu in symptomatic reduction of chronic tonsillitis in children.

时间窗: To evaluate the combined effect of Apamarga Kshara Pratisarana with Vachadi Kwatha Kavala and | Kaishora Guggulu in symptomatic reduction of chronic tonsillitis in children | Duration 21 days | Follow up after 7 days | Total - 28 days

次要结局

  • Children with enlarged tonsils/sthoola shopha(28 days)

研究者

发起方
Dr amarnath dunage
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr amarnath dunage

Sdm college of ayurveda hospital and research centre kuthpady, udupi.

研究点 (1)

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