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CTRI Number  CTRI/2025/09/094736 [Registered on: 15/09/2025] Trial Registered Prospectively
Last Modified On: 13/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to evaluate the combined effect of Apamarga Kshara Pratisarana with Vachadi Kwatha Kavala and Kaishora Guggulu in Tundikeri 
Scientific Title of Study   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.” 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr amarnath dunage 
Designation  MD kaumarabhritya  
Affiliation  Sdm college of ayurveda hospital and research centre kuthpady, udupi. 
Address  Department of pg studies in kaumarabhritya SDM college of ayurveda kuthpady udupi Udupi KARNATAKA 574118 India
Department of pg studies in kaumarabhritya SDM college of ayurveda kuthpady udupi Udupi
Udupi
KARNATAKA
574118
India 
Phone  9158002250  
Fax    
Email  Amarnathdunage143@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Drprathviraj puranik 
Designation  Professor and Head of the department  
Affiliation  Sdm college of ayurveda hospital and research centre kuthpady,udupi. 
Address  Department of pg studies in kaumarabhritya SDM college of ayurveda kuthpady udupi Udupi
Department of pg studies in kaumarabhritya SDM college of ayurveda kuthpady udupi Udupi
Udupi
KARNATAKA
574118
India 
Phone  7760293385  
Fax    
Email  drprathvirajpuranik@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr amarnath dunage 
Designation  MD kaumarabhritya  
Affiliation  Sdm college of ayurveda hospital and research centre kuthpady,udupi. 
Address  Department of pg studies in kaumarabhritya SDM college of ayurveda kuthpady udupi Udupi
Department of pg studies in kaumarabhritya SDM college of ayurveda kuthpady udupi Udupi
Udupi
KARNATAKA
574118
India 
Phone  9158002250  
Fax    
Email  Amarnathdunage143@gmail.com  
 
Source of Monetary or Material Support  
Dr.amarnath dunage Department of pg studies in kaumarabhritya SDM college of ayurveda kuthpady Udupi- 574118 India  
 
Primary Sponsor  
Name  Dr amarnath dunage 
Address  Department of pg studies in kaumarabhritya SDM college of ayurveda kuthpady Udupi-574118.India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr prathviraj puranik  sdm college of ayurveda hospital and research centre kuthpady udupi. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr amarnath dunage  sri dharmasthala manjunatheshwara college of ayurveda hospital and research centre kuthpady  Department of pg studies in Kaumarabhritya General OPD 11 sri dharmasthala manjunatheshwara college of ayurveda hospital and research centre kuthpady udupi
Udupi
KARNATAKA 
9158002250

Amarnathdunage143@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC SDM college of Ayurveda kuthpady udupi.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.apamarga kshara pratisarana 2.kaishora guggulu 3.vachadi kwatha kavala  1.apamarga kshara pratisarana local application once in a day one pinch just before food uniformly all over lesion with spatula for 7 days 2.kaishora guggulu 500mg 1 bd and 1 tid based on age group of 5-8 and 9-12 years for 21 days 3.vachadi kwatha kavala for 7 days  
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  1. Children with syndromic or other systemic illness with or without medication.
2. Children with acute exacerbation of chronic tonsillitis, sinusitis, ear infection, fever etc.
3. Children presenting with complications of tonsillitis. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the combined effect of Apamarga Kshara Pratisarana with Vachadi Kwatha Kavala &
Kaishora Guggulu in symptomatic reduction of chronic tonsillitis in children. 
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 
 
Secondary Outcome  
Outcome  TimePoints 
Children with enlarged tonsils/sthoola shopha  28 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
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.
 
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