| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J039||Acute tonsillitis, unspecified. Ayurveda Condition: TUNDIKERI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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). |