| CTRI Number |
CTRI/2025/01/079423 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha
Other (Specify) [Case Series] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A Study on Effectiveness of KADUKKAI CHOORANAM and KARUNGALI KUDINEER in the management of VEEZHI AKKARAM in the Pediatric Age Group |
|
Scientific Title of Study
|
PRECLINICAL AND CLINICAL EVALUATION OF THE EFFECT OF KADUKKAI CHOORANAM(INTERNAL) AND KADUKKAI CHOORANAM (INTERNAL) WITH KARUNGALI KUDINEER(GARGLING) IN THE MANAGEMENT OF VEEZHI AKKARAM(STOMATITIS) IN CHILDREN - A DOUBLE ARM STUDY |
| 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 K Sevvanthy |
| Designation |
PG SCHOLAR |
| Affiliation |
Government siddha medical College and Hospital,Palayamkottai. Tirunelveli |
| Address |
PG First year,Department of Kuzhanthai Maruthuvam,Government siddha medical College and Hospital,Palayamkottai.
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8973946858 |
| Fax |
|
| Email |
sevvanthykannan1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J Sriram MD S |
| Designation |
Lecturer Grade II |
| Affiliation |
Government siddha medical College and Hospital,Palayamkottai. Tirunelveli |
| Address |
Department of Kuzhanthai Maruthuvam,Government siddha medical College and Hospital,Palayamkottai.
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9486811230 |
| Fax |
|
| Email |
sriramsiddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr J Sriram MD S |
| Designation |
Lecturer Grade II |
| Affiliation |
Government siddha medical College and Hospital,Palayamkottai. Tirunelveli |
| Address |
Department of Kuzhanthai Maruthuvam,Government siddha medical College and Hospital,Palayamkottai.
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9486811230 |
| Fax |
|
| Email |
sriramsiddha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical College and Hospital,Palayamkottai.
Tirunelveli, Tamil Nadu, India.
Pin Code-627002
|
|
|
Primary Sponsor
|
| Name |
Dr K Sevvanthy |
| Address |
Department of Kuzhanthai Maruthuvam, Government Siddha Medical College and Hospital,Palayamkottai, Tirunelveli, Tamil Nadu, India.
Pin Code - 627002 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Ireland |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Sevvanthy |
Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli |
Department of Kuzhanthai Maruthuvam Branch IV,Government Siddha Medical College and Hospital,Palayamkottai.
Tirunelveli
Tirunelveli
TAMIL NADU |
8973946858
sevvanthykannan1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K121||Other forms of stomatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KADUKKAI CHOORANAM(INTERNAL) |
Should be administered orally twice a day after food. Dosage(according to age group and body weight).6-12 Years; 1/2-1 grams; Duration: 7-14 days |
| Comparator Agent |
KADUKKAI CHOORANAM(INTERNAL) AND KARUNGALI KUDINEER(GARGLING) |
Should be administered orally twice a day after food. Dosage (according to age group and body weight).6-12 Years-1/2-1 grams Duration:7-14 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Blisters and ulceration in the mouth
Ulceration in the mouth along with dysgeusia
Fever
Coated tongue
polydipsia
Malnutrition |
|
| ExclusionCriteria |
| Details |
Children below 6 Years and above 12 Years
Traumatic ulcer
Herpetic gingiva stomatitis
Oral ulcers due to stress
Mouth cancer
Candida albicans(Oral thrush)
Oral ulceration due to medications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will understand the effects of KADUKKAI CHOORANAM(INTERNAL) AND KARUNGALI KUDINEER(GARGLING) in the management of VEEZHI AKKARAM(STOMATITIS) in Children |
7-14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
BACKGROUND :
Akkaram is one among tha Agakkarana
Noigal.In Siddha system,akkaram occurs due to excess heat production in the
moolam and affect the oral cavity to induce ulceration.According to the
balavagadam text book,akkaram is classified into 8 types.Out of which veezhi
akkaram is the one.
I have chosen the topic VEEZHI
AKKARAM for my dissertation. Siddha texts describe "VEEZHI AKKARAM" as a
disease characterised by inflammation of the
tongue,Redness of the tongue,Mouth sore and Headache . These symptoms are
similar to the symptoms of "STOMATITIS†mentioned in contemporary modern
literature which includes inflammation of the tongue,Redness of the
tongue,Mouth sore and Headache . .
Considering the above
explanation and symptoms
of the disease I have chosen the medicine KADUKKAI
CHOORANAM(Internal) and KARUNGALI KUDINEER (Gargling). The ingredient of the medicine
has good effect in controlling above conditions. OBJECTIVE: To explore the therapeutic effectiveness of “KADUKKAI CHOORANAM(INTERNAL)†and "KADUKKAI CHOORANAM"(INTERNAL) WITH “KARUNGALI KUDINEER(GARGLING)†in
the management of VEEZHI AKKARAM(STOMATITIS) through comparative clinical trial.
|