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CTRI Number  CTRI/2025/08/092437 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Ayurveda formulation on speech in cerebral palsy  
Scientific Title of Study   Evaluation of saraswata churna and samvardhana ghrita on speech in cerebral palsy - A Randomized controlled clinical trial  
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 Shinde Samrudhi Vishwas 
Designation  PG Scholar 
Affiliation  KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Department of Kaumarbhritya KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya Belgaum

Belgaum
KARNATAKA
590003
India 
Phone  8830495002  
Fax    
Email  samrudhi.shinde524@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Azizahmed Arbar 
Designation  HOD and Professor 
Affiliation  KLE Shri B M Kankanwadi Ayurveda Mahavidyalaya 
Address  OPD no 10 Depatment of Kaumarbhritya KLE Shri B M Kankanwadi Ayurveda Mahavidyalaya Belgaum

Belgaum
KARNATAKA
590003
India 
Phone  09844532113  
Fax    
Email  azizarbar.kaher@kleayurworld.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Azizahmed Arbar 
Designation  HOD and Professor 
Affiliation  KLE Shri B M Kankanwadi Ayurveda Mahavidyalaya 
Address  OPD no 10 Depatment of Kaumarbhritya KLE Shri B M Kankanwadi Ayurveda Mahavidyalaya Belgaum

Belgaum
KARNATAKA
590003
India 
Phone  09844532113  
Fax    
Email  azizarbar.kaher@kleayurworld.edu.in  
 
Source of Monetary or Material Support  
KLE Ayurveda Hospital, Beglavi 
 
Primary Sponsor  
Name  KLE Ayurveda Hospital 
Address  KAHER Shri BMK Ayurveda Mahavidyalaya,Shahapur,Belgavi 
Type of Sponsor  Research institution and hospital 
 
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 Shinde Samrudhi Vishwas  KLE Ayurveda Hospital  Room number 10 and 11 Department of Kaumarbhritya
Belgaum
KARNATAKA 
8830495002

samrudhi.shinde524@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research on Human Subjects KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya And KLE Ayurveda Hospital Shahapur Belgavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R471||Dysarthria and anarthria. Ayurveda Condition: VAK-SANGAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Vakshuddhikar Churna, Reference: Ashtanga hrudaya uttarasthana balopacaramiya adhyaya 1/49, Route: Oral, Dosage Form: Churna/ Powder, Dose: 8(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Saraswata Churna, Reference: Sahasrayoga churna prakarana 72, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information:
3Intervention ArmDrugClassical(1) Medicine Name: Samvardhana Ghrita, Reference: Kashyapa Samhita Lehana Adhyaya 18, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Patients with cerebral palsy of either sex in age group between 3years to 16 years
Patients fulfilling the diagnostic criteria will be included for the study
Children who have previous MRI report which is suggestive of diagnosis of cerebral palsy
 
 
ExclusionCriteria 
Details  Children with any chronic or acute other systemic illness
Known cases of primary aphasia
Children who are known cases of deaf mutism
At the time of enrolment if the child is found to be non inclusive due to underlying health condition or medication which may interfere with study outcome like cleft lip cleft palate muscle relaxants anti-epileptics
Children with conditions that are contraindicated for nasya
 
 
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 
Measured by changes in Viking Speech Scale  0 day
15 thday
30 thday 
 
Secondary Outcome  
Outcome  TimePoints 
Measured by changes in communication function classification system and parameters of vakpravritti  0 th day
15 thday
30 thday 
 
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)   01/01/2026 
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 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  

Cerebral Palsy is a group of permanent disorders of movement and posture. It may develop into a range of secondary conditions over time that will variably affect functional abilities, such as disturbed neuromuscular control of speech mechanisms, often resulting in communication disorders especially poor speech production in patients with CP. Cerebral palsy (CP) is the most common cause of motor disability worldwide, with a prevalence of 2 to 2.5 per 1000 live births. Due to non-progressive disturbances in the developing fetal or infant brain, it causes limitation of activity. Cerebral Palsy is physiologically classified into four main types: Spastic, Dyskinetic, Ataxic, or Mixed. Of all these, Spastic Cerebral Palsy is the most common.

Several comorbidities distinguish the clinical picture of children with CP, such as communication impairment, feeding difficulties, intellectual disability, vision and hearing impairment, and epilepsy. Communication difficulties in CP include altered phonation, low speech intelligibility, abnormal development of gesture and facial expression, and receptive and expressive language impairment. Communication impairment has been identified in at least 40% of children with CP. About 36 to 90% of children undergo motor speech impairments. The treatment of speech usually depends on the severity and includes speech therapy and physical exercises that focus on strengthening the muscles involved in speech.

Oral muscle relaxant drugs such as diazepam, baclofen, and dantrolene may have side effects like impaired memory, confusion, attention deficits, ataxia, and weakness.

Saraswata churna and Samvardhana ghrita are formulations mentioned by Acharyas in Sahasrayoga and Kashyapa Samhita respectively. These are indicated in conditions like vakgraha, muka, and swara sanshtana roga. Such properties may help improve speech in cerebral palsy.

 
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