| CTRI Number |
CTRI/2024/12/078584 [Registered on: 26/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study to find out the effectiveness of the ayurvedic drug darvyadi kashay syrup in disease tonsillitis which is called tundikeri as per ayurveda in comparision with the effect of betadine gargle in the same disease. |
|
Scientific Title of Study
|
Randomised controlled clinical trial on efficacy of darvyadi kashay in tundikeri with special refrence to tonsillitis in children age group 6 to 12 years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRavikiran Chhabilal Deore |
| Designation |
MD scholar kaumarbhritya |
| Affiliation |
Shree saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik |
| Address |
Department of kaumarbhritya Shree saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
8425052691 |
| Fax |
|
| Email |
ravikiran.deore.98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Shankarrao Surse |
| Designation |
HOD |
| Affiliation |
Shree Saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik 422003 |
| Address |
Department of kaumarbhritya Shree saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9224297523 |
| Fax |
|
| Email |
drsurseys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Shankarrao Surse |
| Designation |
HOD |
| Affiliation |
Shree Saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik 422003 |
| Address |
Department of kaumarbhritya Shree saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9224297523 |
| Fax |
|
| Email |
drsurseys@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree saptshrungi Ayurved mahavidhyalaya and hospital kamalnagar hirawadi nashik 422003 |
|
|
Primary Sponsor
|
| Name |
Shree saptshrungi Ayurved mahavidhyalaya and hospital kamalnagar hirawadi nashik 422003 |
| Address |
Department of kaumarbhrityaShree saptshrungi Ayurved mahavidhyalaya and hospital kamalnagar hirawadi nashik 422003 |
| Type of Sponsor |
Private medical college |
|
|
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 Ravikiran Chhabilal Deore |
Shree saptshrungi ayurved mahavidhyayla and hospital |
department of kaumarbhritya 2nd floor Shree saptshrungi ayurved mahavidhyalaya and hospital nashik 422003
Nashik
MAHARASHTRA |
8425052691
ravikiran.deore.98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree saptshrungi Ayurved mahavidhyalaya nashik |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vachadi kashay , Reference: Yogratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | betadine povidine iodine 2%w/v | betadine povidine iodine 2%w/v will be use in the patient with tonsillitis , tundikeri as per ayurveda to compare the effect of the betadine and darvyadi kashay syrup in tonsilltis |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1patients presenting with two or more symptoms like kanthshotha todavatvedana ragatva asyavairasya galoprodha as described in the context of tundikeri
2 children of age group 6 to 12 years either gender irrespective of caste and religion
3 chronic and recurrent tonsillitis |
|
| ExclusionCriteria |
| Details |
1patient suffering from infectious disease 2 patient with peritonsillar abscess tonsillar cyst and tonsillolith will be excluded 3 patient with known case of HIV TB and hepatitis B will be exclude |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
to reduce the swelling of the tonsils,
to reduce the pain while swallowing,to reduce the throat congestion, to reduce the redness and uneasiness feeling in the thorat and to reduce the recurrecy of the tonsillitis in age group 6 to 12 years |
as follow up are set within 7 days, we will observe the patient for the above mentioned complaints and signs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| in secondary outcome the recurrency & the signs & symptoms like pain while swallowing should be reduced & the severeness also reduce this is secondary outcome of the trial |
7 days |
|
|
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)
|
04/01/2025 |
| 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="2"
Days="0" |
|
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
|
OBJECTIVES primary Objective 1. To study efficacy of darvyadi kashay in tundikeri w.s.r to tomsillitis in children of age group 6 to 12 years
2.to study the efficacy of betadine povidine iodine 2% w/v in tujdikeri w.s.r to tonsilltis in children of age group 6 to 12 years
3 to compare the efficacy of darvyadi kashay with betadine gargle in management of tundikeri w.s.r to tonsillitis in children with age group 6 to 12 years
Participant 6 to 12 years children with tundikeri tomsillitis meeting inclusion and exclusion criteria from opd and ipd of department of kaumarbhritya of shree saptshrungi ayurved mahavidhyala and hospital nashik
Intervention 30 patients vachadi kashay syrup- administer as per standard protocol 30 patient betadine gargles administer according as per standard protocol
Primary outcome- to reduce the sign and symptoms of tundikeri
Secondary outcome- no recurrency of tundikeri
Treatment duration- 7 days
Follow up : 0th, 4th, 7th days
Data analysis- Data will be analysed using approprite statistical methods to study the efficacy of vachadi kashay on primary and seconadary outcome.
Ethical consideration- the study will be comducted in accordance with ethical guideline and with informed consent from participants. |