| CTRI Number |
CTRI/2025/05/086880 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the effectiveness of Kandathri Legium for the treatment of throat infection in children |
|
Scientific Title of Study
|
An open clinical trial to evaluate the effectiveness of Kandathri Legium for the treatment of Virana Silethumam [Acute Pharyngotonsillitis] in children among Outpatients attending Ayothidass Pandithar Hospital, National Institute of Siddha |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Priyadarshini |
| Designation |
Postgraduate Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17,
Department of Kuzhandhai Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai,
Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8903404227 |
| Fax |
|
| Email |
priyavenkatesan2797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Arul Mozhi |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17,
Department of Kuzhandhai Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai,
Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9500151930 |
| Fax |
|
| Email |
drarulmozhi2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Arul Mozhi |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17,
Department of Kuzhandhai Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai,
Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9500151930 |
| Fax |
|
| Email |
drarulmozhi2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,
Tambaram Sanatorium,
Chennai,
Kancheeepuram,
Tamilnadu 600047 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha, Tambaram Sanatorium, Chennai, Kancheeepuram, Tamilnadu 600047 |
| 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 V Priyadarshini |
Ayothidass Pandithar Hospital,National Institute of Siddha |
Room no 16/17,
Department of Kuzhandhai Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai,
Kancheepuram
Kancheepuram
TAMIL NADU |
8903404227
priyavenkatesan2797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,National Institute of Siddha |
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 |
Kandathri Legium |
should be administered twice a day orally after food (dosage based on weight and age),duration-24 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Enlarged tonsils with Brodsky scale Grade 2 and above, or Children with positive throat culture [GABHS],or Children having at least three of the symptoms like sore throat,cough, difficulty in swallowing,fever,halitosis,tender swollen cervical lymph nodes |
|
| ExclusionCriteria |
| Details |
Children with symptoms of
1. Pneumonia,
2. Oral Candidiasis,
3. Tuberculosis,
4. Peritonsillar abscess |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The efficacy of trial drug will be assessed by reduction in grade of Brodsky Scale and also by improvement in clinical conditions |
On duration of 24 days of drug every seventh day patients will be assessed by Brodsky Scale for tonsillar enlargement and also by improvement in clinical conditions. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/05/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective open non randomized phase II clinical trial to evaluate the therapeutic efficacy of trial drug Kandathri Legium according to body weight adminstering orally twice a day for 24 days in 30 patients during the trial period of 12 months that will be conducted in Ayothidass Pandithar Hospital National Institute of Siddha Tambaram sanatorium chennai The effectiveness of drug will be assessed based on reduction in quantitative assessment scales of clinical symptoms |