| CTRI Number |
CTRI/2024/05/067003 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of vagshudhikar churna and nasaya in speech fluency disorders |
|
Scientific Title of Study
|
A Randomized clinical controlled trial on speech fluency
disorders in children with combination of Anutail Nasya
and Vagshudhikar Churna |
| Trial Acronym |
RACE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubhangi thakur |
| Designation |
Assistant professor |
| Affiliation |
Government Ayurved college Osmanabad |
| Address |
Gaganmahal B-7 Sir Pochkhanwala Road Worli Mumbai
OPD No37 Kaumarbhritya OPD Osmanabad MAHARASHTRA 413501
Osmanabad
MAHARASHTRA
400030
India |
| Phone |
9404622180 |
| Fax |
|
| Email |
shubhangikthakur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil B Kale |
| Designation |
professor |
| Affiliation |
GOVERNMENT AYURVED COLLEGE OSMANABAD OSMANABAD |
| Address |
Government Ayurved College OSMANABAD
OPD NO 37 KAUMARBHRITYA OPD OSMANABAD MAHARASHTRA 413501
Osmanabad
MAHARASHTRA
413102
India |
| Phone |
9822961494 |
| Fax |
|
| Email |
kaleanilb@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil B Kale |
| Designation |
professor |
| Affiliation |
GOVERNMENT AYURVED COLLEGE OSMANABAD OSMANABAD |
| Address |
Government Ayurved College OSMANABAD
OPD NO 37 KAUMARBHRITYA OPD OSMANABAD 413501
Osmanabad
MAHARASHTRA
413102
India |
| Phone |
9822961494 |
| Fax |
|
| Email |
kaleanilb@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Ayurved college Tuljapur road Osmanabad 413501 |
|
|
Primary Sponsor
|
| Name |
Dr shubhangi thakur |
| Address |
Government Ayurved college Tuljapur Road Osmanabad 413501 |
| 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 shubhangi thakur |
Government Ayurved college osmanabad |
OPD NO 37 KAUMARBHRITYA OPD Government Ayurved college, Tuljapur road, Osmanabad
Osmanabad
MAHARASHTRA |
9404622180
shubhangikthakur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Ayurved college Osmanabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
fluency speech problems |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: KASHAYP SAHMITA, Procedure details: Purvakarma local snehan and sewdan
Pradhan karma Anu tail drops in nose 2 to 4 drops in each nostrils 3 cycles for 7 days.)
(1) Medicine Name: Anu taila, Reference: kashap sahmita, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 21 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vagshudhikar Churna, Reference: Asthang Hridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -madhu), Additional Information: -dosage of churna calculated as per age and weight | | 3 | Comparator Arm (Non Ayurveda) | | - | speech therapy | speech therapy by speech therapist for three months |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
children of the age group of 2 -12 Years
Speech related problems in consequence with delayed developmental Milestones |
|
| ExclusionCriteria |
| Details |
Suffering from sensory aphasia or dysphasia
Children suffering from cleft palate& Cleft lip or the conditions where the surgical
intervention is required
Speech disorders secondary to disorders like cerebral palsy are excluded
Speech disorders which are complicated with other systemic disorders
Children suffering from Dysphonia & Dysarthria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
evaluation of dysfluencies during reading and conversation by using 100 word sample method |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| efectiveness of treatement and better approach towards modification of treatement on fluency disorders |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
23/05/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 randomized clinical controlled trial comparing the saftey and efficacy of combination of vagshudhikar churna doses for patient according to age for three months with Anu tail Nasaya 3cycles of 21 days and another group will be with only speech therapy in age 2 to 12 years of age children the primary outcome measures will be evaluation of dysfluencies during reading at 6 weeks the secondary outcome will be overall effectiveness and better approach towards the treatement of fluency disorders at 12 weeks |