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CTRI Number  CTRI/2023/04/051863 [Registered on: 21/04/2023] Trial Registered Prospectively
Last Modified On: 19/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of tonsillitis through ayurvedic line of management 
Scientific Title of Study   A controlled clinical study to evaluate the effect of tilanala kshara pratisarana in tundikeri (chronic tonsillitis)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shreekanta Tippannanavar 
Designation  2nd Year MS (Ayu) Scholar 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College 
Address  Dept.Of P.G.Studies In Shalakya Tantra Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center Koppal

Koppal
KARNATAKA
583231
India 
Phone  9632660889  
Fax    
Email  charlieee321@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Veerayya R Hiremath 
Designation  Professor & HOD 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College 
Address  Dept Of PG Studies In Shalakya Tantra, SJGAMC, Post Graduate Studies & Research Center

Koppal
KARNATAKA
583231
India 
Phone  9448544376  
Fax    
Email  drvrh.aug15@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Veerayya R Hiremath 
Designation  Professor and HOD 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College 
Address  Dept Of PG Studies In Shalakya Tantra SJGAMC Post Graduate Studies and Research Center

Gadag
KARNATAKA
583231
India 
Phone  9448544376  
Fax    
Email  drvrh.aug15@gmail.com  
 
Source of Monetary or Material Support  
Dr Shreekanta Tippannanavar 2nd PG Scholar Shri Jagadguru Gavisiddheshwar Ayurvedic Medical College Post Graduate Studies And Research Center 
 
Primary Sponsor  
Name  Department Of Shalakya Tantra 
Address  Shri Jagadguru Gavisiddheshwar Ayurvedic Medical College Post Graduate Studies And Research Center 
Type of Sponsor  Research institution and hospital 
 
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 Shreekanta Tippannanavar  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College, Post Graduate Studies And Research Center  Department Of Shalakya Tantra Room No 01
Koppal
KARNATAKA 
9632660889

charlieee321@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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
1Comparator ArmProcedure-pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः (Procedure Reference: : Sushruta: Sushruta Samhita With Dalhana Nibandha Sangraha And Gayadas Nyaya Chandrika Panjika Commentary Edited By Vaidya Yadavji Trikamji Acharya, Published By Chaukambha Sanskrit Samsthana, Varanasi. Reprint Edition – 2014, Chikitsa Sthana 22/57, Page No. 409, Procedure details: Apamarga Kshara Pratisarana Followed By Nimbu Swarsa Kavala For 30 Seconds 3 Sittings In 7 Days))
(1) Medicine Name: Kamadugha rasa, Reference: Ayurveda Sara Sangraha, Rasa Rasayana Prakarana, Kamadudha Rasa Page No 327, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 7 Days
2Intervention ArmProcedure-pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः (Procedure Reference: Shree Sadananda Sharma: Rasa Tarangini. Edited by Pandit Kashinathshastri. Dwitiya Taranga, Ksharaashtaka Verse 8. Page No. 12. Shree Narahari Pandith. Raja Nighantu. Chaukambha Orientalia Varanasi. Mishrakaadivarga, verse 48-49. Page No. 1073, Procedure details: Tilanala Kshara Pratisarana Followed By Nimbu Kavala For 30 Seconds 3 Sittings In 7 Days)
(1) Medicine Name: Kamadugha Rasa, Reference: Ayurveda Sara Sangraha ,Rasa Rasayana Prakarana Kamadudha Rasa Page No 327, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 7 Days
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1 Patients having the symptoms of chronic tonsillitis (Tundikeri). 
 
ExclusionCriteria 
Details  1 Tonsillitis with cardinal signs like peritonsillar abscess, parapharyngeal abscess, intra tonsillar abscess.
2 Conditions like Diphtheria, Tonsiloliths which mimic Tonsillitis.
3 Patients with Systemic diseases that needs long treatment.
4 Pregnant women and lactating mothers.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To observe the reduction in enlarged tonsils and pain  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the amount of reduction in dysphagia, congestion and sore throat  21 days 
 
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 4 
Date of First Enrollment (India)   01/05/2023 
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="0"
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  

 Tundikeri is a Mukharoga categorized under Taluroga1 by Sushruta and Kantha roga by Vagbhata where he compares it to vana karpasa phala2. It is caused due to vitiation of Kapha and Rakta dosha and it is characterized by Jwara (fever), toda (pricking pain), daha (burning), shopha (inflammation) and prapaki (suppuration) in talupradesha3. The samanya chikitsa in Tundikeri includes pratisarana, chedana karma, kavalagraha and dhumapana4. This can be correlated to tonsillitis.

          Tonsils are muco-lymphoid tissues situated in oro-pharynx at the gateway of oro-pharyngeal route and considered as one of the chief immuno component tissues. Thus more prone to get infection from nasal route as well as oral route and become hypertrophic, this inflammation causes tonsillitis. It is characterized by pricking pain, sore throat, cough, halitosis and dysphagia. The prevalence of tonsillitis in adults was formulated approximately, 77% female are affected with tonsillitis than 22.9% of male. Among the responders, 75% have tonsillitis and remaining 25% doesn’t have tonsillitis5. It is treated by analgesics like Paracetamol, Aceclofenac and Anti-Microbial drugs like Amoxicillin potassium clavulanate, Azithromycin. In chronic cases Tonsillectomy6 is recommended. Frequent episodes of the infection interfere with normal growth and development of the child. Due to incomplete treatment or resistance of organisms to antibiotics, tonsillitis can reach chronic stage. It has common side effects in children like nausea, headache, abdominal pain, diarrhea, gastric upset7.

          In chronic tonsillitis as there is hypertrophy of the tonsillar tissue is present, which can be considered as adhimamsa and according to acharya charaka ‘ksharo Arbuda adhimamseshu kriya’…||8 the line of treatment is Kshara application. Pratisaraneeya Kshara acts on hypertrophied tonsils by cauterization of mass because of its corrosive nature. Thus produces shrinking effect on tonsillar hypertrophy.     

             In Tundikeri Pratisaraneeya kshara is one of the treatment protocol, which does chedana, bhedana, lekhana and it is safe procedure in the condition of chronic tonsillitis with enlarged tonsils where tonsillectomy is not really required. Tilanala kshara is one among the ksharaastaka9,10 and  having katu, tikta rasa, Sukshma, vyavayi guna and usna veerya. Hence Tilanala kshara pratisarana is taken out as trial group in the management of Tundikeri with Apamarga kshara pratisarana as a controlled group.

 
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