To evaluate clinical efficacy of ayurvedic package in children suffering from cerebral palsy

Phase 2/3

Not yet recruiting

• Conditions: Cerebral palsy, unspecified. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH,

• Registration Number: CTRI/2024/03/063397
• Lead Sponsor: Banaras HIndu University

Brief Summary

Cerebralpalsyis defined as a nonprogressive neuromotor disorder of cerebralorigin. It includes heterogeneous clinical states of variable etiology andseverity ranging from minor incapacitation to total handicap. Cerebral palsy (CP) is the leading cause ofchildhood disability affecting function and development.

Motor disorders of CP are often accompanied bydisturbances of sensation, perception, cognition, communication and behavior. Mostof the cases have multiple neurological deficits and variable mental handicap.It is difficult to estimate the precise magnitude of the problem since mildcases are likely to be missed.

Approximately1-2 per 100 live births isa reasonable estimate of the incidence.

The global prevalence of CP is 2:1000 of the manytypes and subtypes of CP, none has any known “cure.†Ayurveda has a separatebranch of clinical specialization concerning child healthcare known asKaumÄrabhá¹›tya. There is no one to one correlation available in Ayurvedicclassics with CP, but there are many conditions and some causative factorslinked to etiopathology for such type of disease condition described in manychapters in different texts.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-02-28
• Study Start: 2024-09-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Irrespective to sex.
• Age between 1 to 10 years, suffering from any types of CP due to different etiology..
• Whom parents have given consent for the participation of their kids in the proposed clinical trial.

Exclusion Criteria

• Any CP child suffering any associated life- threatening diseases, malignancy, congenital heart disease, HIV, diabetes, congenital genetic disorder etc.
• Patient/parent, has quit denied participating between the clinical during study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CBC LFT RFT CT brain MRI Brain Urine R M Stool R M EEG	Monthly follow up for 6 months

Secondary Outcome Measures

Name	Time	Method
Anthropometry, milestones, muscle power, muscle tone, Deep tendon reflexes, Cortical thumb, Scissoring, drooling of saliva	monthly follow up for 6 months

Trial Locations

Locations (1)

Sir Sunderlal Hospital, IMS, BHU; 🇮🇳 Varanasi, UTTAR PRADESH, India

Sir Sunderlal Hospital, IMS, BHU

🇮🇳Varanasi, UTTAR PRADESH, India

Dr P S Upadhyay

Principal investigator

7355422083

psupadhyay08@gmail.com