| CTRI Number |
CTRI/2024/06/069475 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
09/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate effectiveness of Saruva thitha nirgundi thailam for the treatment of throat infection in children. |
|
Scientific Title of Study
|
An Open Clinical Trial to evaluate the effectiveness of Saruva Thitha Nirgundi Thailam for the treatment of Virana Silethumam (Acute Pharyngo-Tonsillitis) in Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarathi |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Kuzhanthai Maruthuvam National Institute of Siddha Tamabaram sanatorium Chennai.
FF2 hansavandana apartments Naidushop road, Chrompet -600044
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7358536124 |
| Fax |
|
| Email |
dr.sivasarathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Suresh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Kuzhanthai Maruthuvam, National Institute of Siddha, Tamabaram sanatorium, Chennai.
Chennai
TAMIL NADU
600047
India |
| Phone |
9962571137 |
| Fax |
|
| Email |
drsureshherbal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Suresh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Kuzhanthai Maruthuvam, National Institute of Siddha, Tamabaram sanatorium, Chennai.
Chennai
TAMIL NADU
600047
India |
| Phone |
9962571137 |
| Fax |
|
| Email |
drsureshherbal@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,
Tambaram sanatorium, chennai- 600047 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 S Sarathi |
Ayothidoss pandithar hospital |
Department of Kuzhanthai maruthuvam, National Institute Of Siddha, Tambaram sanatorium, Chennai-6000047
Chennai
TAMIL NADU |
7358536124
dr.sivasarathi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The 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 |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Saruva Thitha Nirgundi Thailam |
5 to 7 years- 3ml and
8 to 12 years - 5ml, twice a day for 14 days.
oil bath weekly once |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with age group of 5 to 12 years of both sex.
Enlarged tonsils with Brodsky scale Grade 2 and above.
children also having at least three of the following symptoms:
1. Throat pain
2. Cough
3. Difficult to swallow
4. Fever
5. Halitosis |
|
| ExclusionCriteria |
| Details |
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 |
Efficacy of the trial drug will be assessed based on reduction in quantitative assessment scales of clinical symptoms.
Enlargement of tonsils will be assessed by Brodsky scale.
Throat pain will be assessed by VAS score.
Cough severity will be assessed by VAS score.
Dysphagia will be assessed based on Bazaz dysphagia scale.
Halitposis will be assessed based on organoleptic score. |
Baseline at the time of enrolment - 0th day.
First follow up - 7th day.
Second follow up- 14th day.
End point 28th day. |
|
|
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)
|
01/08/2024 |
| 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
|
There are more number of cases recorded with complaints of fever, dysphagia and enlarged tonsils. So this is the need of the hour to explore a safe and effective siddha remedy to overcome this disease. The selected experimental drug for this study SARUVA THITHA NIRGUNDI THAILAM is indicated for Annakku Thooru Thabitham in the siddha textbook of THERAYAR THAILAVARGA SURUKKAM. The various ingredients of SARUVA THITHA NIRGUNDI THAILAM possess heat potency to reduce the elevated Kabam, so that it will be very effective in reducing the symptoms of VIRANA SILETHUMAM. |