| CTRI Number |
CTRI/2019/12/022493 [Registered on: 23/12/2019] Trial Registered Prospectively |
| Last Modified On: |
14/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of the effect of siddha classical drug Adathodai nei for the treatment of TONSILLITIS. |
|
Scientific Title of Study
|
Clinical evaluation of the effect of Adathodai nei for treatment of Annakku thooru thaabitham. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanimozhi Y |
| Designation |
Post Graduate Student |
| Affiliation |
Government siddha medical college and hospital ,palayamkottai. |
| Address |
Department of kuzhanthai maruthuvam,
Government siddha medical college and hospital,
Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442447922 |
| Fax |
|
| Email |
ykanimozhi2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soundararajan D K |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of kuzhanthai maruthuvam,
Government siddha medical college and hospital,
Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442048801 |
| Fax |
|
| Email |
dr.dks.2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soundararajan D K |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of kuzhanthai maruthuvam,
Government siddha medical college and hospital,
Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442048801 |
| Fax |
|
| Email |
dr.dks.2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and hospital,Palayamkottai,Tirunelveli-627002. |
|
|
Primary Sponsor
|
| Name |
Kanimozhi Y |
| Address |
Department of kuzhanthai maruthuvam,
Government siddha medical college and hospital,
Palayamkottai,
Tirunelveli,
627002. |
| Type of Sponsor |
Other [self] |
|
|
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 |
| YKanimozhi |
Government siddha medical college and hospital,Palayamkottai. |
Department of kuzhanthai maruthuvam,Government siddha medical college and hospital,Palayamkottai,Tirunelveli-627002.Tamilnadu.
Tirunelveli
TAMIL NADU |
9442447922
ykanimozhi2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Siddha Medical College, Palyamkottai, Tirunelveli-627002, Tamil Nadu, India |
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 |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Ä€á¹ÄtÅá¹ai ney |
Should be administered orally thrice a day after food along with cukku kuá¹inÄ«r for a period of 14 days.Dosage - 500 mg |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with any of the following symptoms will be included in the study
Enlarged Tonsils
Throat pain
Dysphagia
Hoarseness of voice
Other symptoms such as
Referred pain in the ear,Malaise,Mild fever with Tonsillitis. |
|
| ExclusionCriteria |
| Details |
Subjects with
Congenital anomalies of pharynx
Known case of TB Tonsillitis or Malignancy
Physiological hyperplasia of lymphoid follicles
Peritonsillar abscess
will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Enlarged Tonsils
Throat pain
Dysphagia
Hoarseness of voice |
Day 1 to week 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessed by Tonsillitis grading.
|
2 Weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/12/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
It is a single arm clinical trial to evaluate the safety and efficacy of Adathodai nei in patients with Annakku thooru thaabitham |