| CTRI Number |
CTRI/2022/02/040176 [Registered on: 10/02/2022] Trial Registered Prospectively |
| Last Modified On: |
09/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Panchkoladi Gutika in the management of Tonsillitis |
|
Scientific Title of Study
|
Open randomised controlled clinical study on efficacy of Panchkoladi Gutika in the management of Tundikeri |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana Ajit Brahmadande |
| Designation |
PG scholar Kaumarbhritya |
| Affiliation |
Hon shri Annasaheb Dange Ayurved medical college and post graduate research center, Ashta |
| Address |
Department of Kaumarbhritya Hon shri Annasaheb Dange Ayurved medical college and post graduate research center, Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9970311709 |
| Fax |
|
| Email |
archana3160@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali Dinesh Kamat |
| Designation |
Guide and HOD |
| Affiliation |
Hon shri Annasaheb Dange Ayurved medical college and post graduate research center, Ashta |
| Address |
Department of Kaumarbhritya Hon shri Annasaheb Dange Ayurved medical college and post graduate research center, Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9890924594 |
| Fax |
|
| Email |
anjudkamat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Archana Ajit Brahmadande |
| Designation |
PG scholar Kaumarbhritya |
| Affiliation |
Hon shri Annasaheb Dange Ayurved medical college and post graduate research center, Ashta |
| Address |
Department of Kaumarbhritya Hon shri Annasaheb Dange Ayurved medical college and post graduate research center, Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9970311709 |
| Fax |
|
| Email |
archana3160@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon shri Annasaheb Dange Ayurved medical college and post graduate research center Ashta |
|
|
Primary Sponsor
|
| Name |
Hon shri Annasaheb Dange Ayurved medical college and post graduate research center Ashta |
| Address |
Hon shri Annasaheb Dange Ayurved medical college and post graduate research center Ashta |
| 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 |
| Archana Ajit Brahmadande |
Hon Shri Annasaheb Dange Ayurved Medical College and PG Research center, Ashta, |
Department of Kaumarbhritya Hon Shri Annasaheb Dange Ayurved Medical College and PG Research center, Ashta
Sangli
MAHARASHTRA |
9970311709
archana3160@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe |
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: Panchakoladi gutika, Reference: Gadanigraha mukhrogadhikar 131 132, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: khadiradi Gutika, Reference: Bheshaj ratnavali 56-62, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group 7-11 years, both male and female.
2) Patients suffering from acute attack of Tundikeri |
|
| ExclusionCriteria |
| Details |
1) Patients with peri tonsillar abscess, tonsillar cyst, tonsillolith.
2) Patients with any other systemic disorders.
3) Other conditions which mimic tonsillitis eg. Diptheria, herpes etc. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the efficacy of panchkoladi gutika in the management of Tonsillitis.
To evaluate weather the symptoms of Tonsillitis i.e sore throat, difficulty in swallowing, swollen tonsils, enlarged lymph node are minimizing by the use of panchkoladi gutika |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To review the literature of Tundikeri |
4 weeks |
|
|
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)
|
12/02/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I Archana Ajit Brahmadande PG Scholar of Kaumarbhritya Department trying to evaluate the efficacy of panchkoladi gutika in the management of tundikeri. During this trial i try to evaluate untoward effect of panchakoladi gutika on tundikeri (tonsillitis). As there is no previous work done on panchkoladi gutika, so emphasis will be made to find out easy, cost effective method to control tundikeri. |