| CTRI Number |
CTRI/2020/03/024335 [Registered on: 30/03/2020] Trial Registered Prospectively |
| Last Modified On: |
27/03/2020 |
| 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
|
Effect Of Kushtadi Powder Application In Tonsillitis |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study On The Effect Of Kushtadi Choorna Pratisarana In Tundikeri W.S.R To Tonsillitis In Children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayalekshmi S |
| Designation |
PG Scholar |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
Sri Sri College Of Ayurvedic Science And Research
21st KM Kanakapura Road, PO-Udayapura Department Of PG Studies In Kaumarabhritya
21st KM, Kanakapura Road, PO-Udayapura
Bangalore Rural KARNATAKA 560082 India |
| Phone |
7034902561 |
| Fax |
|
| Email |
mailjayalekshmis@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sudheer B R |
| Designation |
HOD, Professor |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
Department Of PG Studies In Kaumarabhritya
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH
21ST KM KANAKAPURA ROAD, PO-UDAYAPURA Department Of PG Studies In Kaumarabhritya
Sri Sri College Of Ayurvedic Science And Research
Bangalore Rural KARNATAKA 560082 India |
| Phone |
9900175777 |
| Fax |
|
| Email |
sudheerbrao@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jayalekshmi S |
| Designation |
PG Scholar |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
Sri Sri college Of Ayurvedic Science And Research
21st KM, Kanakapura Road,PO-Udayapura Department Of PG Studies In Kaumarabhritya
Sri Sri College Of Ayurvedic Science And Research
21st KM, Kanakapura Road, PO-Udayapura
Bangalore Rural KARNATAKA 560082 India |
| Phone |
7034902561 |
| Fax |
|
| Email |
mailjayalekshmis@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College Of Ayurvedic Science And Research
21st KM, Kanakapura Road, PO- Udayapura, Bengaluru, 560082 |
|
|
Primary Sponsor
|
| Name |
Sri Sri College Of Ayurvedic Science And Research |
| Address |
21st KM Kanakapura Road, PO-Udayapura, Bengaluru |
| Type of Sponsor |
Private medical college |
|
|
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 Sudheer B R |
Sri Sri College Of Ayurvedic Science And Research |
Department of PG Studies In Kaumarabhritya
21st KM, Kanakapura Road, PO- Udayapura Bangalore Rural KARNATAKA |
9900175777
sudheerbrao@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J039||Acute tonsillitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KUSHTADI CHURNA APPLICATION |
2g. Of Kushtadi Choorna Will Be Applied Locally Over Tonsils In Children Diagnosed With Tonsillitis Once In A Day For 7 Days |
| Comparator Agent |
SPHATIKA BHASMA |
2g. Of Sphatika Bhasma Will Be Applied Locally Over Tonsils In Children Diagnosed With Tonsillitis Once In A Day For 7 Days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of age group of 6-10 years will be included.
2. Subjects of both gender will be included irrespective of Religion and Socioeconomic status.
3. Subjects diagnosed with Tundikeri(Tonsillitis) will be included.
4. Subjects in whom the consent form is signed by parents/Guardian will be included.
|
|
| ExclusionCriteria |
| Details |
1. Subjects below 6 years and above 10 years will be excluded.
2. Subjects having other Chronic Systemic diseases like Post streptococcal Glomerulo nephritis, Rheumatic fever etc will be excluded.
3. Subjects with peritonsillar abscess, tonsillar cyst and tonsilolith will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| By Application Of Kushtadi Choorna Over Tonsils Locally, Reduction In The Symptoms Of Tonsillitis Will Be Assessed by assessing Reduction In The Size Of Enlarged Tonsils, Throat pain, Odynophagia, Dysphagia, Congestion over Tonsils And Pillars, Cough, Fever, Jugulodygastric lymphedenopathy, Halitosis, Change in voice |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare The Effect Of Herbal And Mineral Medicines In Tonsillitis |
7 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 2 |
|
Date of First Enrollment (India)
|
31/03/2020 |
| 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="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
UGC APPROVED JOURNALS |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acute
infections of the upper respiratory tract contribute to over 20% of the
morbidity of the population with the highest incidence in children. Among upper
respiratory infections, Tonsillitis most often occurs in children aged 5-15
years without gender difference. Sore throat has an annual
incidence of 100 in 1000 with Tonsillitis accounting for approximately 32 in
1000 patients per year.
The Tonsils are the immune system’s
first line of defense against pathogens whenever there is an infection in oral
cavity and upper respiratory system which may make the tonsils vulnerable to
infection and inflammation. Antibiotics are the main line of treatment for
Tonsillitis in Allopathic system of medicine which treats the current infection,
but repeated administration of antibiotics can lead to many adverse effects
like Nausea, Abdominal pain and blotting, Loss of appetite etc.
The disease Tundikeri
mentioned in Ayurveda can be correlated to Tonsillitis which is characterized
by- swelling in the throat especially Hanusandhi similar to Karpasaphala(fruit
of cotton plant) which is Pichila(slimy) Katina(hard) and
having Mandaruja(pain).
Tundikeri is one among the Mukhagataroga(Diseases of
Oral cavity) as mentioned in different classics and Pratisarana(Local application)is considered as one among the main
line of treatment in Tundikeri to reduce the local inflammation, pain and makes the deglutition easy.
In the current study Kushtadi choorna is selected
for Pratisarana. The drugs have Anti inflammatory, Anti microbial,
Analgesic and Anti pyretic actions which may effectively control Tonsillitis at
an initial stage and prevent secondary infections. |