FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062968 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 16/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Curative and Preventive]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Dashmuladi Kashaya & Haritaki Kashaya in the management of Tundikeri(chronic tonsillitis) in children. 
Scientific Title of Study   A randomized controlled clinical study to evaluate efficacy of Dashmuladi Kashaya & Haritaki Kashaya in the management of Tundikeri(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 Ashwini Ashokrao Patil 
Designation  Assistant Professor  
Affiliation  Govt Ayurved college ,Nanded 
Address  Govt Ayurved college,Department of Kaumarbhritya, Vazirabad,Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  9420247156  
Fax    
Email  organotech99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepak Khawale 
Designation  Professor 
Affiliation  Dr D.Y.Patil Ayurved college and research center Pimpri 
Address  Department of Kaumarbhritya, D.Y.Patil Ayurved college, Pimpri, Pune.

Pune
MAHARASHTRA
411018
India 
Phone  919923220055  
Fax    
Email  drdeepak77@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepak Khawale 
Designation  Professor 
Affiliation  Dr D.Y.Patil ayurved college and research center,Pimpri 
Address  Department of Kaumarbhritya, D.Y.Patil Ayurved college,Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  919923220055  
Fax    
Email  drdeepak77@rediffmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College Nanded  
 
Primary Sponsor  
Name  Dr Ashwini Ashokrao Patil 
Address  Department of Kaumrbhritya, Dr D.Y.Patil ayurved college and research center, Pimpri, Pune  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Ashwini Ashokrao Patil  Govt Ayurved college,Nanded  OPD no 2 and IPD of Department of Kaumarbhritya
Nanded
MAHARASHTRA 
9420247156

organotech99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr D.Y.Patil college of Ayurveda and research center, Pimpri  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. Ayurveda Condition: TUNDIKERI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Dashmuladi Kashaya, Reference: Bhavprakash , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Sharkara), Additional Information: By application of Young formula dose of drug is calculated for each patient
2Comparator ArmDrugClassical(1) Medicine Name: Haritaki Kashaya, Reference: Ashtang Hridayam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: By application of Young formula dose of medicine for each patient is calculated.
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Patients having two or more symptoms of chronic tonsillitis or tundikeri.

Patients with chronic tonsillitis except positive throat culture for Group A streptococcus 
 
ExclusionCriteria 
Details  Patients with Quinsy, Tonsillolith.
Patients with any other systemic disorder.
Patients with positive Group A streptococcus throat culture.
Patients below 5 years and above 12 years of age. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Chronic tonsillitis (Tundikeri) cured or not cured on the basis of symptoms and signs.
Kathin shotha(enlarged tonsils)
Mand Ruk(sore throat)
Picchilata(exudates)
Difficulty in swallowing
Halitosis

 
at base line at 8th day,16th day and 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Complete blood count
 
at base line at8th & at 16th day 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   27/02/2024 
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="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   Topic name : A randomized controlled clinical study to evaluate efficacy of Dashmuladi Kashaya and Haritaki Kashaya in the management of Tundikeri (chronic tonsillitis)in children. 

Study settings : OPD and IPD of Govt Ayurveda college Nanded

Study population : Patients of Tundikeri coming to OPD and IPD of Govt Ayurved College,Nanded

Nature of sample : Pediatric patients of Tundikeri (chronic tonsilliti) of age 5 years to 12  years will be selected after screening of subjects for inclusion.

Sampling size : by randomized sampling technique 50 patients each in Trial and control group. Total 100.

Intervention: Control group - Haritaki kashaya
                        Trial/Experimental group - Dashmuladi kashaya
Duration of intervention- 15 days
Assessment on Follow ups at 7, 16, 30 th day


 
Close