| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R471||Dysarthria and anarthria. Ayurveda Condition: VAK-SANGAHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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: | | 3 | Intervention Arm | Drug | Classical | | (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. |