| CTRI Number |
CTRI/2024/06/068728 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on Thaeththuvai chooranam and Varma therapy in the management of thaeththuvai |
|
Scientific Title of Study
|
Effectiveness of thaeththuvai chooranam varma therapy in the management of thaeththuvai (stuttering speech) among pediatric age group - A case series |
| 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 G PANDIPRIYA |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college and hospital, palaymkottai |
| Address |
PG second year
Department of kuzhanthai maruthuvam,
Government siddha medical college and hospital, palayamkottai,
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7094951009 |
| Fax |
|
| Email |
pandipriya.g97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S GEETHA DEVI |
| Designation |
Associate professor |
| Affiliation |
Government siddha medical college and hospital, palayamkottai |
| Address |
Department of kuzhanthai maruthuvam,
Government siddha medical college and hospital, palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7401757475 |
| Fax |
|
| Email |
geethadevis16@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR S GEETHA DEVI |
| Designation |
Associate Professor |
| Affiliation |
Government siddha medical college and hospital, Palayamkottai |
| Address |
Department of kuzhanthai maruthuvam,
Government siddha medical college and hospital, palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7401757475 |
| Fax |
|
| Email |
geethadevis16@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli.
Pin Code 627002
India |
|
|
Primary Sponsor
|
| Name |
Dr G PANDIPRIYA |
| Address |
PG scholar second year, Dpartment of kuzhanthai maruthuvam, Government siddha medical college and hospital,palayamkottai
Tirunelveli |
| 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 |
| Dr G PANDIPRIYA |
Government Siddha Medical College and Hospital, Palayamkottai. |
Department of Kuzhanthai Maruthuvam,
Branch _ PG IV,
Op room no _ 12,
Government Siddha Medical College and Hospital,Palayamkottai,
Tirunelveli
Tirunelveli
TAMIL NADU |
7094951009
pandipriya.g97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE 2023-2026, Government Siddha Medical College and Hospital Palayamkottai 627002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R478||Other speech disturbances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
External therapy ( Varma therapy) _ ottu varmam, nalliruppu adangal, amirtha adangal, naaku adangal,naaku sarvanga adangal, soll adangal. |
Varma therapy _ once a day |
| Intervention |
Internal medicine _ Thaeththuvai chooranam
|
Internal medicine: Administrated orally once a day [early morning only]. Dosage [according to age of the patient]. Duration- one month |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with disfluent speech
Patients who are willing to involve in the study
|
|
| ExclusionCriteria |
| Details |
Stuttering occured after surgery,
Anatomical deformity in vocal cord by birth,
Stuttering associated with genetic disorder,
Family history of stuttering
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome will be aimed at reducing the symptoms of thaeththuvai (stuttering speech) and to determine the effectiveness of thaeththuvai chooranam and varma therapy |
4month |
|
|
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)
|
21/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
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
|
EFFECTIVENESS OF "THAETHTHUVAI CHOORANAM" AND VARMA THERAPY IN THE MANAGEMENT OF "THAETHTHUVAI" [STUTTERING SPEECH] AMONG PEDIATRIC AGE GROUP - A CASE SERIES.
BACKGROUND: IN SIDDHA LITERATURE, THAETHTHUVAI IS REFERRED AS STUTTERING SPEECH. STUTTERING SPEECH IS CHARACTERIZED BY REPETITION OF SOUNDS, SYLLABLES OR WORDS, PROLONGATION OF SOUNDS AND INTERRUPTIONS IN SPEECH KNOWN AS BLOCKS |