| CTRI Number |
CTRI/2025/12/098249 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparing herbal Gargle (Triphala with Tankana Kshara) and Salt Water Gargle for treating Acute Tonsillitis in 8 TO 25 year olds. |
|
Scientific Title of Study
|
Effect of Triphala Kashaya with Tankana Kshara as Kabala compared to Saline water gargling in Acute Tonsillitis in the age group of 8-25 years A Comparative Clinical Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KRISHNENDU T D |
| Designation |
PG scholar |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE KANNUR |
| Address |
Department of salakyatantra
OPD number 8
Government Ayurveda College Pariyaram kannur
Kannur
KERALA
670503
India |
| Phone |
8921849819 |
| Fax |
|
| Email |
Krishnendutd20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V K V Balakrishnan |
| Designation |
Professor |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE KANNUR |
| Address |
Department of Salakyatantra
OPD number 8
Government Ayurveda College Pariyaram Kannur
Kannur
KERALA
670503
India |
| Phone |
9447037892 |
| Fax |
|
| Email |
baluvkv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V K V Balakrishnan |
| Designation |
Professor |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE KANNUR |
| Address |
Department of Salakyatantra
OPD number 8
Government Ayurveda College Pariyaram Kannur
Kannur
KERALA
670503
India |
| Phone |
9447037892 |
| Fax |
|
| Email |
baluvkv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra, Government Ayurveda college hospital, Pariyaram, Kannur, Kerala,670502 |
|
|
Primary Sponsor
|
| Name |
Dr KRISHNENDU T D |
| Address |
Dr KRISHNENDU T D
PG SCHOLAR
Department of salakyatantra
OPD number 8
Government Ayurveda College Pariyaram Kannur
Kerala
India |
| 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 KRISHNENDU T D |
Government Ayurveda College Hospital Pariyaram Kannur |
Department of Shalakyatantra
OPD Room number - 8
Government Ayurveda College hospital Pariyaram Kannur
Kannur
KERALA |
8921849819
Krishnendutd20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GIOVERNMENT AYURVEDA COLLEGE KANNUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J039||Acute tonsillitis, unspecified. Ayurveda Condition: TALUGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: ashtangahridaya, Procedure details: Purification of tankana,Tankana should be powdered after purchasing from open market.
1)This should be kept over a pan which will be heated over mandagni, then it is supposed
to tivragni.
2) After sometime sound will come & water content will be evaporated.last white lighter substance is obtained & this is called shodhitha tankana9.
➢ For the age group of 8 – 17 years Tankana kshara Bhasma will be given as 125 mg in
divided doses twice daily (morning & evening after food) & for the age group of 18
– 25 years it will be given as 250 mg in divided doses twice daily (morning & evening)
with 50 ml of Triphala kashaya for gargling for 7 days.
PROCEDURE OF KABALA
POORVAKARMA
➢ Patient will be made to sit comfortably on the chair.
➢ Mridu nadi swedana will be done.
PRADHANAKARMA
➢ The patient is asked to gargle medication half of the oral cavity (vakrardha matras
pravara matra as per ashtangahridaya) in such a way it should reach the oropharyngx.
➢ In age groups between 8-25 years the amount of medicated liquid used for gargling can
be standardised depends upon the half of the oral cavity of the participants.
➢ The procedure is continued till the Samyak kabala lakshana appears – Kaphapoorna
aasyatha, Netrasruthi & Ghranasruthi.
➢ The participants will be instructed to gargle the medicated fluid up to 2 minutes.In
the case of children, the parents will be able to note gargling time up to 2 minutes.)
| | 2 | Intervention Arm | Procedure | - | gargling | (Procedure Reference: nelson book of pediatrics, Procedure details: 1)Saline water gargling is done for 2 minutes twice daily after food.)
| | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: amruthotharam, Reference: sahasra yogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: sarkara), Additional Information: nil |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with at least any one of the symptoms presenting with clinical manifestations
of Acute Tonsillitis such as Throat Pain, Inflammed tonsils (which occupies up to 50% of oropharyngeal width, the tonsil
doesn’t go beyond the tonsillar pillars), Sore throat, Dysphagia
2. Participants who has tonsillar enlargement resulting with odynophagia and history of
fever is included.
3. Subjects who are indicated for kabala procedure.
4. Subjects who are willing to give an informed written consent form and an assent form.
|
|
| ExclusionCriteria |
| Details |
1. Participants suffering from other systemic illness and associated with any malignancies.
2. Participants who are suffering from Bulbar palsy, Facial palsy and those who cannot
follow instructions.
3. Participants with complications of Acute tonsillitis such as Peritonsillar abscess,
Parapharyngeal abscess, Acute otitis media, Otalgia, Acute nephritis, Chronic nephritis,
Rheumatic fever.
4. Subjects who are known for suspected allergic reactions to any study medication.
5. Subjects who are frequently taking Inhalers, Oxygen therapy.
6. Subjects who are mentally compromised and vulnerable cases.
7. Subjects who are allergic to Lignocaine. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
FRIEDMAN GRADING SCALE
• SYMPTOMATIC GRADING SCORE
• Patient diary.
OBJECTIVE PARAMETER
• Photography of tonsils of participants before and after the treatment period. |
0th, 7th and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Throat swab culture |
0th and 7th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2025 |
| 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="6"
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
|
Acute Tonsillitis is the inflammation of the tonsils, mainly attributed to viral/bacterial infections in which the predisposing factors are primary infection of tonsils /secondary to upper respiratory tract infections, poor oro dental hygiene and weakened immunity and commonly affects children and young individuals between the ages of 5 and 18, and is rarely seen in people over 50 years old. Symptoms includes Congested Swollen tonsils, Sore throat, Throat Pain while swallowing, fever(38-40 c) with chills and rigors, earache, enlarged jugulo-digastric lymph nodes and constitutional symptoms such as headache, general body aches ,constipation. Standard management often includes antimicrobial therapy, adjunctive treatments such as gargling solutions are commonly used for symptomatic relief. Considering the signs and symptoms of Acute Tonsillitis it can be correlated to Tundikeri in ayurveda described under mukharoga which has predominance of kapha and rakthadoshas.Tundikeri chikitsa involves Pratisarana, kabala, dhoomapana, vamana, raktamokshana, gandusha and pradhamana nasya.In this treatment modalities, Sodhana kabala is safe and best for pacifying the vitiated kapha doshas ,predominant doshas in the mukharoga and this study is planned to compare the effective of Triphala Kashaya with Tankana Kshara as Kabala against saline water gargling in the treatment of acute tonsillitis. A comparative clinical trial with 40 Subjects satisfying inclusion criteria will be assigned into the two Groups A and B and will be administered Triphala kashaya with Tankana kshara and saline water gargling respectively along with Amruthotharam kashayam internally for both groups. The effect of both interventions can be assessed by Friedman’s grading scale, symptomatic grading scores , Photography of tonsils and Throat swab culture evaluated from the baseline, on the 7 th day and follow up on 15th day. Results will be statistically analysed after the study. |