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CTRI Number  CTRI/2025/07/091204 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study on Yavagrajadi churna and Pippalyadi churna application and gurgling with Panchavalkala kwatha in Chronic tonsillitis  
Scientific Title of Study   An open label double arm randomized clinical study to compare the efficacy of Yavagrajadi churna pratisarana followed by Panchavalkala kwatha kavala and Pippalyadi churna pratisarana followed by Panchavalkala kwatha kavala in Tundikeri w s r to Chronic 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 Madeeha begum 
Designation  Pg Scholar  
Affiliation  sri kalabyraveswara swamy ayurvedic medical college hospital and research centre banglore  
Address  opd no 21 Department of shalakya tantra sri kalabyraveswara swamy ayurvedic medical college hospital and research centre banglore 10 pipeline road r p c layout vijayanagar bangalore 560104

Bangalore
KARNATAKA
560104
India 
Phone  7337658892  
Fax    
Email  madihamadiha6026@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hamsaveni V 
Designation  PROFESSOR 
Affiliation  sri kalabyraveswara swamy ayurvedic medical college hospital and research centre banglore  
Address  Department of shalakya tantra sri kalabyraveswara swamy ayurvedic medical college hospital and research centre banglore 10 pipeline road r p c layout vijayanagar bangalore 560104

Bangalore
KARNATAKA
560104
India 
Phone  9900110912  
Fax    
Email  vimalbut@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Hamsaveni V 
Designation  PROFESSOR 
Affiliation  sri kalabyraveswara swamy ayurvedic medical college hospital and research centre banglore  
Address  Department of shalakya tantra sri kalabyraveswara swamy ayurvedic medical college hospital and research centre banglore 10 pipeline road r p c layout vijayanagar bangalore 560104

Bangalore
KARNATAKA
560104
India 
Phone  9900110912  
Fax    
Email  vimalbut@yahoo.com  
 
Source of Monetary or Material Support  
Dr Madeeha Begum Room No 21 Dept Of Pg Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore Karnataka India 560104 
 
Primary Sponsor  
Name  Dr Madeeha begum  
Address  Sri kalabyraveswara swamy ayurvedic medical college hospital and research centre bangalore 10 pipeline road r p c layout vijayanagara bangalore 560104  
Type of Sponsor  Other [Dr Madeeha begum] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madeeha begum  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre   Room No 21 Dept Of Pg Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore Karnataka India 560104
Bangalore
KARNATAKA 		 7337658892

madihamadiha6026@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
skamchrc  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J350||Chronic tonsillitis and adenoiditis. Ayurveda Condition: TUNDIKERI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kavalaH, कवलः (Procedure Reference: ashtanga hrudaya , Procedure details: patient is asked to hold required quantity of medicated kashaya in mouth)
(1) Medicine Name: yavagrajadi churna , Reference: chakradatta , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Duration: 7 Days
(2) Medicine Name: panchavalkala kwatha, Reference: chakradatta , sharangadhara samhita , Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 150(ml), Frequency: bd, Duration: 7 Days
2Comparator ArmProcedure-kavalaH, कवलः (Procedure Reference: ashtanga hrudaya, Procedure details: patient is asked to take required quantity of medicated kashaya and asked to gargle )
(1) Medicine Name: pippalyadi churna , Reference: chakradatta , Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Duration: 7 Days
(2) Medicine Name: panchavalkala kwatha, Reference: chakradatta , sharangadhara samhita , Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 150(ml), Frequency: bd, Duration: 7 Days
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  subjects presenting with lakshanas of tundikeri
subjects presenting with the signs and symptoms of chronic tonsillitis
 
 
ExclusionCriteria 
Details  Tonsillitis associated with complications such as Peritonsillar abcess, Parapharyngeal abscess Tonsillar cys Tonsilloliths Intratonsillar abcess
Subjects diagnosed with other systemic disorders which interferes with the course of treatment
Pregnant and lactating women
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the reduction in ruk nigalana kricchrita and mukha dourgandhya with the help of Yavagrajadi churna pratisarana followed by Panchavalkala kwatha kavala and Pippalyadi churna pratisarana followed by Panchavalkala kwatha kavala in Tundikeri w s r to Chronic tonsillitis   2 years  
 
Secondary Outcome  
Outcome  TimePoints 
nil  NA 
 
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   Phase 2 
Date of First Enrollment (India)   15/05/2026 
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="2"
Months="1"
Days="1" 
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  
Tundikeri is described as a Mukha Roga in Ayurvedic classics. It is categorized under Talugata Rogas by Acharya Sushruta and under Kanthagata Rogas by Acharya Vagbhata. The condition is said to resemble the shape of Vanakarpasi Phala (wild cotton fruit) and presents with symptoms such as Shotha (swelling), Toda (pricking pain) Daha (burning sensation)  and Prapaka (suppuration).

The clinical manifestations of Tundikeri closely correlate with Tonsillitis as understood in modern medicine.

According to the Ayurvedic texts, the treatment of Tundikeri includes therapies like Nasya, Asruk Mokshana, and internal medications, along with local applications (Sthanika Upakramas) such as Pratisarana, Kavala, Gandoosha, and Dharana.

For Pratisarana, Yavagrajadi Churna and Pippalyadi Churna, which are mentioned in Chakradatta under Kanthagata Roga Chikitsa Adhikara, have been selected. For Kavala, Panchavalkala Kwatha, referred to by Chakradatta under Mukha Roga and by Sharngadhara under Kwatha Yogas, is used.

These formulations possess Kapha-Pittahara (pacify Kapha and Pitta), Shothahara (anti-inflammatory), Rakta Sthambhaka (hemostatic), Chedana (resolvent), and Vedanahara (analgesic) properties, making them beneficial in the effective management of Tundikeri.
 
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