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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:J350||Chronic tonsillitis and adenoiditis. Ayurveda Condition: TUNDIKERI, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | pratisAraNIya-kShAraH, पà¥à¤°à¤¤à¤¿à¤¸à¤¾à¤°à¤£à¥€à¤¯-कà¥à¤·à¤¾à¤°à¤ƒ | (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 | 2 | Intervention Arm | Procedure | - | pratisAraNIya-kShAraH, पà¥à¤°à¤¤à¤¿à¤¸à¤¾à¤°à¤£à¥€à¤¯-कà¥à¤·à¤¾à¤°à¤ƒ | (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. |