| CTRI Number |
CTRI/2024/02/062968 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J350||Chronic tonsillitis and adenoiditis. Ayurveda Condition: TUNDIKERI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 | | 2 | Comparator Arm | Drug | Classical | | (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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
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
|