| CTRI Number |
CTRI/2025/02/081392 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study on Saraswata Churna In Vak-Graha (Stuttering) In Children. |
|
Scientific Title of Study
|
A Randomized Control Clinical Study to Evaluate The Efficacy of Saraswata Churna in Vak-Graha (Stuttering) 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 |
Dr Rohit Kumar |
| Designation |
PhD scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no 99 P.G.Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra HARYANA 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
8699538627 |
| Fax |
|
| Email |
rohit4u88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kataria |
| Designation |
Associate professor PG Dept. of Kaumarbhritya |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no 99 P.G.Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra HARYANA 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9034001230 |
| Fax |
|
| Email |
dramitkataria@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Kumar |
| Designation |
Phd Scholar |
| Affiliation |
Institute for Ayurved Studies and Resea |
| Address |
Room no 99 P.G.Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra HARYANA 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
8699538627 |
| Fax |
|
| Email |
rohit4u88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Former Shri Krishna Government Ayurvedic College and Hospital Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118 India |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Institute for Ayurved Studies and Research Former Shri Krishna Government Ayurvedic College and Hospital Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118 |
| Type of Sponsor |
Government medical college |
|
|
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 Rohit Kumar |
Institute for Ayurved Studies and Research |
PG Department of Kaumarbhritya Institute For Ayurved Studies and Research, Kurukshetra Umri road Sector 8 Thanesar Kurukshetra Haryana
Kurukshetra
HARYANA |
8699538627
rohit4u88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna AYUSH University IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F801||Expressive language disorder. Ayurveda Condition: VAK-SANGAHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Speech Therapy | Speech therapy will be done in patient with stuttering. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saraswata churna , Reference: Sharangdhar Samhita Madhyama Khanda chapter 6 shlok 1, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Ghrit), Additional Information: -Dose will be calculated with the help of clarks formula and Speech therapy also done with Saraswata churan |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children in between the age group of 4- 12 years of either sex irrespective of caste, religion
and socio-economic status.
Any pauses, repetition, prolongation of vowels or words.
Slurring of words and distortion of vowels because of lack of strength and muscular control,
causing dysfluency in speech. |
|
| ExclusionCriteria |
| Details |
Patient suffering from sensory aphasia or dysphasia.
Patient suffering from cleft palate & cleft lip or the conditions where the surgical intervention
is required.
Speech disorders secondary to disorders like cerebral palsy etc.
Speech disorders which are complicated with other systemic disorders.
Patient suffering from Dysphonia & Dysarthria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will measure change in the clinical symptoms of Stuttering. |
60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in score of Stuttering severity instrument-3 to assess the efficacy of selected drug.
Assessment of the safety of the drug by documenting the occurrence of any adverse drug
reactions (ADR)/ adverse events (AE) during the course of the study. |
90th 120th 150th and 180th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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
|
A randomized clinical trial has been designed to assess the efficacy of Saraswata churan with speech thearpy in the management of Vak-Graha in children of age group 4 year to 12 year is
selected from O.P.D. of Kaumarbhritya Department of Institute for Ayurved Studies and Research |