| CTRI Number |
CTRI/2024/07/071289 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate the effect of Rudraksha along with speech therapy in pre-school children with language related problems |
|
Scientific Title of Study
|
Randomised clinical study to evaluate the efficacy of Rudraksha lehana as an add-on to speech therapy in language disorders of pre-school 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 Vaishnevi Kannan Velu |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
JSS Ayurveda Medical College and Hospital
Kumarabhritya OPD no 11
41E Lalitadripura Road Alanahalli Mysuru
Mysore KARNATAKA 570082 India |
| Phone |
7760135367 |
| Fax |
|
| Email |
kvaishnevi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jyothy K B |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
JSS Ayurveda Medical College and Hospital
Kaumarabhritya OPD no 11
41E Lalitadripura Road Alanahalli Mysuru
Mysore KARNATAKA 570082 India |
| Phone |
7776014076 |
| Fax |
|
| Email |
jyothybmenon@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vaishnevi Kannan Velu |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
JSS Ayurveda Medical College and Hospital
Kaumarabhritya OPD no 11
41E Lalitadripura Road Alanahalli Mysuru
Mysore KARNATAKA 570082 India |
| Phone |
7760135367 |
| Fax |
|
| Email |
kvaishnevi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rudraksha will be obtained from authentic sources and will be verified by Department of Dravya Guna JSSMAC Mysuru Churna will be prepared in Rasa Shastra and Bhaishajya Kalpana laboratory |
|
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Primary Sponsor
|
| Name |
Principal investigator |
| Address |
JSS Ayurveda Medical college and Hospital
41E Lalitadripura Road Alanahalli Mysuru Karnataka India |
| 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 Vaishnevi Kannan Velu |
JSS Ayurvedic Medical College and Hospital |
Kaumarabhritya OPD and IPD
Room no 11
41E Lalithadripura Road Alanahalli Mysuru Mysore KARNATAKA |
7760135367
kvaishnevi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F809||Developmental disorder of speech and language, unspecified. Ayurveda Condition: VAK-SANGAHÂ (KEVALAVATA), |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rudraksha, Reference: Raja nigantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: Intervention as on add-on therapy with standard treatment |
|
|
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Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1)Children in between the age group of 2-6 years irrespective of gender, religion and socioeconomic status.
2)Children diagnosed with language disorders1. (ICD-10-CM F80.9)
|
|
| ExclusionCriteria |
| Details |
1)Known cases of systemic disorders which may interfere with the course of study.
2)Known cases of any congenital anomalies and syndromes affecting speech.
3)Children with generalized cognitive disorders, neuromotor conditions, speech sound disorders and childhood-onset fluency disorders
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 To asses the effect of Rudraksha and speech therapy as per the scores of REELS COMDEALL and ALD scales |
base line
6th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To study the effect of Speech Language therapy in language disorders as per the scores REELS COMDEALL & ALD scales
2 To Compare the effect of both the groups in language disorders as per the scores REELS COMDEALL & ALD scales
|
base line
6th week
12th week
|
|
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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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="1" 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
|
Language disorders /Specific language impairment is characterised by significant variation between the cognitive level and language level. They follow an atypical pattern of language acquisition and use. As per The Federal Individuals with Disabilities Education Act requires early intervention and special education i.e, Speech-Language therapy in such conditions. Language therapy focuses on expanding vocabulary and understanding of semantics, improving syntax and pragmatic. As per the recent evidences, Speech-Language therapy is the choice of treatment for language disorders and these therapies take almost more than 6 months of time period to show any effect. There are currently no pharmacological interventions that treat language disorders. In Ayurveda classics, production of speech is said to be one of the prime functions of Vata Dosha and in sub type of Vata it is of Udana Vata. Avak’ (inablity to speak words) and ‘Vakya Rahita’ (inablity to speak in sentences)are the two terms indicating speech related problems as per Ayurveda. Based on the principles of Ayurveda, Rudraksha can be used for speech delay as it has properties like Vata-Kapha hara, which is the main cause of speech disorders according to Acharya Sushrutha. Hence, based upon the above available references the following study has been designed to understand the role of Ayurveda treatment modality in Language disorders of pre-school childern . |