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CTRI Number  CTRI/2023/10/058917 [Registered on: 19/10/2023] Trial Registered Prospectively
Last Modified On: 29/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Candy preparation for Tonsilitis 
Scientific Title of Study   A Randomised Controlled Clinical Study To Evaluate The Efficacy Of Pippali Choorna Modified Into Lozenges In The Management Of Tundikeri 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 Syamily Raj K 
Designation  PG scholar  
Affiliation  Alvas Ayurveda Medical College 
Address  Department of Kaumarabhritya P G Studies Alvas Ayurveda Medical College Vidyagiri, Moodibidri

Dakshina Kannada
KARNATAKA
574227
India 
Phone  7558078013  
Fax    
Email  drsyamily@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Narayan Pai B 
Designation  Associate Professor 
Affiliation  Alvas Ayurveda Medical College 
Address  Department of Kaumarabhritya P G Studies Alvas Ayurveda Medical College Vidyagiri, Moodibidri

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9902329719  
Fax    
Email  drnarayanpai@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Narayan Pai B 
Designation  Associate Professor 
Affiliation  Alvas Ayurveda Medical College 
Address  Department of Kaumarabhritya P G Studies Alvas Ayurveda Medical College Vidyagiri, Moodibidri

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9902329719  
Fax    
Email  drnarayanpai@gmail.com  
 
Source of Monetary or Material Support  
Alvas Ayurveda Medical College And Hospital, Moodbidri Dakshina Kannada KARNATAKA 574227 India 
 
Primary Sponsor  
Name  Dr Syamily Raj K 
Address  P G Scholar Alvas Ayurveda Medical College Moodibidri, Dakshina Kannada, Karnataka - 574227 
Type of Sponsor  Other [Self ] 
 
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 Syamily Raj K  Alvas Ayurveda Medical College  Department of Kaumarabhritya Alvas Ayurveda Medical College and Hospital, Moodibidri
Dakshina Kannada
KARNATAKA 		 7558078013

drsyamily@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL CLINICAL ETHICS COMMITTEE, ALVAS AYURVEDA MEDICAL COLLEGE, VIDYAGIRI, MOODBIDRI,INDIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J03||Acute tonsillitis. Ayurveda Condition: TUNDIKERI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Pippali choorna, Reference: sharangadhara Samhitha Madhyama Khanda Choorna Yoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: peeth saireyaka lozenges, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Patients of either gender aged between 07 to 15 years.
2. Patients fulfilling the diagnostic criteria
 
 
ExclusionCriteria 
Details  1. Patients suffering from chronic Tonsillitis.
2. Complications like peritonsillar abscess and other systemic disorders.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Assessment will be made on the basis of improvement in the clinical features.
2. Patients will be assessed as per the subjective and objective parameters made for the study.
Subjective
a) Difficulties in a daily life
b) sore throat/pain during swallowing.

Objective
a) Pharyngeal erythema or swelling
b) Fever
c) Tonsillar erythema or swelling
d) Presence of exudates or plugs in tonsils
 		 21days 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment will be made on the basis of improvement in the clinical features.
a) Pharyngeal erythema or swelling
b) Fever
c) Tonsillar erythema or swelling
d) Presence of exudates or plugs in tonsils

 		 21days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   20/10/2023 
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="0"
Days="7" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
This study is randomized, parallel group, actively controlled clinical study with comparative standard
study- Peetha saireyaka lozenges and interventional drug- Pippali choorna modified into lozenges with the dosage of 6gm after food TID in divided doses. The study is conducting on patients of Tundikeri belongs to age of
7years to 15years who gives written and verbal by parents for undergoing clinical Study. Study will
be conducting in Alvas Ayurveda Medical College And Hospital, Vidyagiri, Moodabidri.
Interventional period of this study is 21 days assessment will be done on before treatment, 2nd day, 5th day,
7th day and 21st day.
 
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