| CTRI Number |
CTRI/2025/09/094453 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oral gargling with medicated ayurveda preparation in treating throat infection |
|
Scientific Title of Study
|
A comparitive study to evaluate the efficacy of Darvyadi Kashaya Kavala with and without Kanchanara Guggulu in the management of Tundikeri acute tonsillitis |
| 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 Dombale Kiran Shashikant |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Alvas Ayurveda Medical College and Hospital
Department of Shalakyatantra
Alvas Ayurveda Medical College and Hospital
Vidyagiri
Moodubidire
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9822503959 |
| Fax |
|
| Email |
dombalekiran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satheesha Shankara B |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of Shalakyatantra
Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9482167168 |
| Fax |
|
| Email |
drsatish88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satheesha Shankara B |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of Shalakyatantra
Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9482167168 |
| Fax |
|
| Email |
drsatish88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire Dakshina Kannada Karnataka 574227 |
|
|
Primary Sponsor
|
| Name |
Dr Dombale Kiran Shashikant |
| Address |
Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire Dakshina Kannada Karnataka 574227 |
| 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 Dombale Kiran Shashikant |
Alvas Ayurveda Medical College and Hospital |
Department of Shalakyatantra
Dakshina Kannada
KARNATAKA |
09822503959
dombalekiran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Alvas Ayurveda Medical College |
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 | Comparator Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: Sharangdhara Samhita, Procedure details: Kavala 3 times/ day)
(1) Medicine Name: Darvyadi Kashaya, Reference: Sharangdhara Samhita, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: tds, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: Sharangadhara Samhita, Procedure details: kavala 3 times/ day)
(1) Medicine Name: Darvyadi Kashaya, Reference: Sharangadhara Samhitha , Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: tds, Duration: 7 Days(2) Medicine Name: Kanchanara Guggulu, Reference: Yogaratnakara, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: tds, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical signs and symptoms of Tundikeri as mentioned in diagnostic criteria
Subjects having 3 or less than 3 attacks of tonsillitis |
|
| ExclusionCriteria |
| Details |
Patients below 6 years and above 50 years
Patients with chronic tonsillitis peritonsillar abcess tonsillar cyst tonsillolith
Patients with H/O HIV TB Hepatitis B and other systemic complications
Pregnancy and lactating women
Kavala Anarha |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the reduction in size of tonsils by Brodsky grading scale |
Before treatment
7 th day
14 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Ruk Ragatwa Daha Prapaki Mukha Daurgandhya sore throat malaise will be accessed by grading scale and enlargement of lymph nodes by palpation |
Before treatment
7 th day
14 th day |
|
|
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)
|
20/09/2025 |
| 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="0"
Months="9"
Days="15" |
|
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
|
The study is randomized parallel group controlled comparitive clinical study with Darvyadi Kashaya Kavala with and without Kanchnara Guggulu given in two groupsThe study will be conducted on subjects having Tundikeri belonging to age group 6 to 50 years who has given written consent for undergoing clinical study The study will be conducting in Alvas Ayurveda Medical College and Hospital Moodubidire Dosage of Darvyadi Kashaya Kavala will be according to age as above 18 years 50 ml 10-18 years 25ml 6 -10 years 20ml for period of 7 days Dosage of Kanchanara Guggulu will be given according to age as above 18 years 500mg 10-18 years 250mg 6-10 years 200mg Three times per day after food for period of 7 days Interventional period of the study is 7 days and assessment will be done before treatment on 7th day and Follow up on14thday
|