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CTRI Number  CTRI/2025/08/092141 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 31/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Pathadi Churna in Tundikeri in children with special reference to Tonsillitis 
Scientific Title of Study   Evaluation of Pathadi Churna in management of Tundikeri in Children with special reference to Tonsillitis - A Randomised controlled clinical trial 
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 Jain Aditi Ajay 
Designation  PG Scholar 
Affiliation  KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi 
Address  Department of Kaumarbhritya KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9373908833  
Fax    
Email  aditijain9926@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Veena K H  
Designation  Associate Professor 
Affiliation  KAHER Shri B M K Ayurveda Mahavidyalaya 
Address  OPD no 10 Department of Kaumarbhritya KLE Shri B M Kankanwadi Ayurveda Mahavidyalaya
KLE Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka
Belgaum
KARNATAKA
590003
India 
Phone  09538469641  
Fax    
Email  dr.veenatonne@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Veena K H  
Designation  Associate Professor 
Affiliation  KLE Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi 
Address  OPD no 10 Department of Kaumarbhritya KLE Shri B M Kankanwadi Ayurveda Mahavidyalaya

Belgaum
KARNATAKA
590003
India 
Phone  09538469641  
Fax    
Email  dr.veenatonne@gmail.com  
 
Source of Monetary or Material Support  
KLE Ayurveda Hospital Belagavi  
 
Primary Sponsor  
Name  KLE Ayurveda Hospital Belgavi 
Address  KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya shahapur Belagavi Karnataka 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jain Aditi Ajay  KLE Shri B M Kankanwadi Ayurveda Hospital  OPD no 10 Department of Kaumarbhritya KLE Shri B M Kankanwadi Ayurveda Mahavidyalaya
Belgaum
KARNATAKA 
09373908833

aditijain9926@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for research on Human Subjects KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital Shahapur Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J039||Acute tonsillitis, unspecified. Ayurveda Condition: TUNDIKERI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: kanchanar Guggulu, Reference: Sharangdhar samhita, Madhyam khanda 7/95-98, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Pathadi Churna, Reference: charak samhita , chikitsa sthan 26/199, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Patients of either sex in age group between 6years to 16years
Patients fulfilling the diagnostic criteria will be included for the
study
Acute and Chronic Tonsillitis of Grade 1 and Grade 2 
 
ExclusionCriteria 
Details  Children with fever more than 100 degree Farhenite
Children with tonsillitis of grade 3 and 4
Subjects with complication of tonsillitis such as pre diagnosed
Rheumatic Heart Disease Rheumatic fever
Known cases of peritonsillar abscess tonsillar cyst and tonsilolith
Known cases of Covid 19 and Acute and Chronic lower
respiratory tract infection
Children needing any form of acute management
Children on any medication that may interfere with the outcome
of trial drug example steroid antibiotics  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
There might be significant effect of
Pathadi churna in the management of tundikeri with special reference to tonsillitis in children assessed through Tundikeri scoring scale McIssac score and Modified VAS scale 
0 day
3 days
7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Measured by changes in tonsillitis through Ayurveda scoring scale  0 day
3 days
7 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/01/2026 
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="6"
Days="0" 
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   Tonsillitis is an infection-related inflammation of the tonsils, frequently affecting school going children .The Incidence in school going children in India is 7% .About 7,455,494 cases of tonsillitis and 200,000 tonsillectomies are performed in India per year . Palatine tonsils represent the predominant immunocompetent tissue of upper respiratory tract. Its major function is as a first line of defence against viral, bacterial and food antigens that enter the upper aerodigestive system.
 Another major function of the tonsils is to supply the local mucosal immune system of the upper respiratory tract with dimeric IgA-producing B cells. Secretory IgA has particular hydrophilic properties and is capable of preventing adsorption and penetration of bacteria and virus into upper respiratory tract mucosa .Tonsillitis of viral origin is usually treated with supportive care. Bacterial tonsillitis is most common caused by streptococcus pyogen . 
Tonsillitis causes local immunological damages which lead to frequent development of the disease, hence affecting the child’s growth and development . The most widely used medication for tonsillitis are a group of antibiotics such as Penicillin, amoxicillin, erythromycin etc and surgery known as tonsillectomy, which are having adverse effect such as eruption of skin, nephrotoxicity, diarrhea, life threatening conditions like shock , post-operative bleeding, dehydration, uvular edema and damage or trauma to the adjacent anatomical tissue  . Hence there is a need for alternative treatment modality for the treatment of tonsillitis. 
In Ayurveda Tonsillitis can be understood under the concept of tundikeri, which has various treatment modalities mentioned by Acharyas such as shaman aushadi, kavala , dhoompan, pratisarana, nasya etc. One of such shaman aushadhi mentoned by Acharya Charka is Pathadi churna, by virtue of its properties such as Galarogahara, vata pitta kaphahara doshaaghna, might be effecting in treating tundikeri (tonsillitis).
 
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