| CTRI Number |
CTRI/2024/12/078556 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Interventional study to known the combined effect of samvardhana ghrita and vakshuddhikara choorna in children with speech dealy |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the add on effect of samvardhana ghrita with vakshuddhikara choorna in sppech delay 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 Archana Byahatti |
| Designation |
Phd Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Cuttack, Odisha |
| Address |
Department of Kaumarabhritya, Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri Vihar, Bidyadharpur, Ward No 3, PO-Godisahi, Cuttack, Odisha.
Cuttack
ORISSA
754006
India |
| Phone |
7899589389 |
| Fax |
|
| Email |
archu.byahatti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Byahatti |
| Designation |
Phd Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Cuttack, Odisha |
| Address |
Department of Kaumarabhritya, Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri Vihar, Bidyadharpur, Ward No 3, PO-Godisahi, Cuttack, Odisha.
Cuttack
ORISSA
754006
India |
| Phone |
7899589389 |
| Fax |
|
| Email |
archu.byahatti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Durgaprasad Dash |
| Designation |
Professor and Head |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Cuttack, Odisha |
| Address |
Department of Kaumarabhritya, Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri Vihar, Bidyadharpur, Ward No 3, PO-Godisahi, Cuttack, Odisha.
Cuttack
ORISSA
754006
India |
| Phone |
09853435916 |
| Fax |
|
| Email |
durga.d@srisriuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurveda Science and Research Hospital, Sri Sri University, Sri Sri Vihar, Bidyadharpur, PO-Godisahi, Cuttack-754006 |
|
|
Primary Sponsor
|
| Name |
Dr Archana Byahatti |
| Address |
Sri Sri College of Ayurveda Science and Research Hospital, Sri Sri University, Sri Sri Vihar, Bidyadharpur, PO-Godisahi, Cuttack-754006 |
| 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 Archana Byahatti |
Sanjeevini Ayurveda Medical College And Hospital |
Department of Kaumarabhritya, Sanjeevini Ayurveda Medical College and Hospital, Hubball, Karnataka
Dharwad
KARNATAKA |
7899589389
archu.byahatti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee for Biomedical Research of Faculty of Health and Wellness Sri Sri College of Ayurvedic Science and Research Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F54||Psychological and behavioral factors associated with disorders or diseases classified elsewhere. Ayurveda Condition: MUKATVAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vakshuddhikara choorna, Reference: Ashtanga Hrudaya 1/49, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Honey), Additional Information: Drug Dose 2-5Years -0.5g BD 6-10Years-1g BD | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vakshuddhikara Choorna, Reference: Ashtanga Hrudaya 1/49, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Samvardhana Ghrita), Additional Information: Drug Dose 2-5 Years-0.5g 6-10Years-1g |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children fulfilling the diagnostic criteria will be included for the study.
2. Children of either sex between the age group of 2-10 Years.
3. Children in whom parents are willing to sign the written consent form to participate. |
|
| ExclusionCriteria |
| Details |
1. Childrens in whome parents are hesitant to sign the written consent form to participate
2. Known case of primary aphasia
3. Patients suffering from cleft pallet, cleft lip orthe conditions where the surgical intervention is required
4. children with deaf mutism |
|
|
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 |
| Vakshuddhikara Choorna with Samvardhana Ghrita is effective in the management of speech delay children |
Baseline, 30th, 60th and 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vakshuddhikara Choorna with Samvardhana Ghrita is effective when compared with Vakshuddhikara choorna with honey in the management of speech delay children |
60days of intervention and frequency of asssessment- 0th, 30th, 60th, 90th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/01/2025 |
| 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="6"
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
|
Intelligible speech and language is useful marker for the child’s overall development and intellect. Timely indentification of delay by primary care physicians can allow early intervention and reduce disability. Data from India on this subject is limited. Developmental delay in speech is a common occurrence among young children in India with a prevalence of up to 17%. If Left undiagnosed and untreated, speech delay can lead to other adverse development and health outcomes.Speech is the sound produced , while language is a measure of comprehension, it is a useful marker for the child’s overall development and intellect. Evidence implies that untreated speech and language delay can persist in 40-60% of the children and these children are at a higher risk of social, emotional, behavioural, and cognitive problems in adulthood. Inpresent era speech disorder is one of the burning problems in childhood age problems involving speech there are several biological and psychological factors that can affect speech. Swara is given importance in the diagnosis of different aspects like Swastha, Prakriti preeksha, Sara Pareeksha and vyadhi nishchaya, Kashyapa has given importance to swara saying that sara can be understood by the swara of the person. Researches has been done on effect of vakshuddhikara choorna in stuttering hence this study id conducted to evaluate the add on effect of samvardhana ghrita with vakshuddhikara choorna in speech delay children. |