| CTRI Number |
CTRI/2019/08/020832 [Registered on: 21/08/2019] Trial Registered Prospectively |
| Last Modified On: |
30/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on shreshtavyoshadi vati external application to tonsils and Dashamulyadi kashaya orally in Chronic tonsillitis. |
|
Scientific Title of Study
|
A longitudinal observational study to assess the effectiveness of shreshtavyoshadi pratisarana and Dashamulyadi kashaya orally in 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 ANKITHA C S |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA MEDICAL COLLEGE,BANGALORE |
| Address |
ABHIGNA NILAYA,SOMAGUDDU POST, CHELLAKERE TALUK, CHITRADURGA DISTRICT, KARNATAKA STATE,INDIA
GOVERNMENT AYURVEDA MEDICAL COLLEGE,DHANVANTARI ROAD,BANGALORE-560009
Bangalore
KARNATAKA
577522
India |
| Phone |
9686703384 |
| Fax |
|
| Email |
ankithacbhuvana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SYED MUNAWAR PASHA |
| Designation |
HOD,DEPARTMENT OF SHALAKYA TANTRA |
| Affiliation |
GOVERNMENT AYURVEDA MEDICAL COLLEGE,BANGALORE |
| Address |
DEPARTMENT OF SHALAKYA TANTRA,OPD NO.09, GOVERNMENT AYURVEDA MEDICAL COLLEGE,DHANVANTARI ROAD,BANGALORE-560009
Bangalore
KARNATAKA
560009
India |
| Phone |
9886593932 |
| Fax |
|
| Email |
smpasha78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANKITHA C S |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA MEDICAL COLLEGE,BANGALORE |
| Address |
ABHIGNA NILAYA,SOMAGUDDU POST, CHELLAKERE TALUK, CHITRADURGA DISTRICT, KARNATAKA STATE,INDIA
GOVERNMENT AYURVEDA MEDICAL COLLEGE,DHANVANTARI ROAD,BANGALORE-560009
Bangalore
KARNATAKA
577522
India |
| Phone |
9686703384 |
| Fax |
|
| Email |
ankithacbhuvana@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR ANKITHA C S |
| Address |
ABHIGNA NILAYA, SOMAGUDDU POST, CHELLAKERE TALUK, CHITRADURGA-577522, KARNATAKA |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ANKITHA C S |
GOVERNMENT AYURVEDA MEDICAL COLLEGE, BANGALORE |
DEPARTMENT OF SHALAKYA TANTRA, ENT SECTION, OPD NO.09.GOVERNMENT AYURVEDA MEDICAL COLLEGE, DHANVANTARI ROAD, BANGALORE-560009
Bangalore
KARNATAKA |
9686703384
ankithacbhuvana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, GOVERNMENT AYURVEDA MEDICAL COLLEGE, BANGALORE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. SHRESHTAVYOSHADI PRATISARANA
2. DASHAMULYADI KASHAYA |
1. SHRESHTAVYOSHADI VATI PRATISARANA QUANTITY SUFFICIENT ONCE IN A DAY FOR 7 DAYS.
2. DASHAMULYADI KASHAYA 25 ML TWICE A DAY FOR 48 DAYS. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. SUBJECTS PRESENTING WITH CLASSICAL FEATURES OF CHRONIC TONSILLITIS.
|
|
| ExclusionCriteria |
| Details |
1. Subjects diagnosed with peritonsillar abscess, tonsillar cyst, and tonsillolith will be excluded.
2. Subjects associated with any chronic debilitating disorders.
3. Pregnant and lactating women.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| PICTORIAL REPRESENTATION |
78 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BRODSKY GRADING SCALE |
78 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/09/2019 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Tonsils are the body’s first line of defense at the oro-pharyngeal gateway. Chronic tonsillitis (ICD-J35.0) is one of the commonest chronic infection, characterized by recurrent acute attacks. Tonsillitis is an inflammation of the tonsils and especially the palatine tonsils typically due to viral or bacterial infection.The prevalence rate of Tonsillitis in India is >1million cases/ year.
The recurrent attack of tonsillitis makes the disease chronic & vulnerable for infectious diseases & causes several health hazards like laryngeal oedema, acute otitis media and quinsy.
In case of recurrent attacks the only treatment of choice is surgery in conventional medical science. Considering the increased rate of incidence, non availability of effective medical measures , possible complications of surgery and anaesthesia like airway obstruction with respiratory compromise, primary and secondary post operative bleeding and non affordability for surgery, and surgical removal of lymphoid tissue(tonsils) arises a question of debate which can affect the body defence mechanism. so the need arises to research for effective measures which would help in treating the condition.
In Ayurveda tonsillitis can be correlated to Tundikeri (NAMC CODE- GE-3) Which presents with Kathinasotha resembling Karpasaphala, Toda, daha, paaka. Hence this study has been taken. The composition of shreshtavyoshadivati and Dashamulyadikashaya are easily available, cost effective, easy to administer ,safe and effective. HYPOTHESIS: Null hypothesis H0-shrestavyoshadi pratisarana and dashamoolyadi kashaya orally has no significant result in the management of tundikeri. Alternate hypothesis H1-shrestavyoshadi pratisarana and dashamoolyadi kashaya orally has significant result in the management of tundikeri.
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