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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 
 
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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F809||Developmental disorder of speech and language, unspecified. Ayurveda Condition: VAK-SANGAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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
 
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

 
 
Method of Generating Random Sequence   Computer generated randomization 
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

 
 
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 classicsproduction 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 .

 
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