Effectiveness of Injii chooranam Along with Vathakesari thylam For Balavatham in children

Phase 2

Completed

Conditions: Diseases of the nervous system,

Registration Number: CTRI/2023/06/053514

Lead Sponsor: National Institute Of Siddha

Brief Summary: **INTRODUCTION**:

This is an open non -randomized single arm single centric clinical trial to evaluate the effectiveness of INJII CHOORANAM (Internal) and Vathakesari thylam(external) for the management of Balavatham in children.In the pediatric text book of Mathalai noi thokuthi part 3,the symptoms of Balavatham is explained as inability /difficulty to use the limb,loss of power and tone,nerve weakness,inability to move the affected limb,deviation,loss of energy,weakness,chills,spasticity of the affected part.The drugs chosen for the project included INJI CHOORANAM as internal medicine,VATHAKESARI THYLAM as external medicine for thokkanam all of which have been used in the siddha system of medicine for many centuries either singly or in various combination.In order to limit this issue,efforts were undertaken to study the result of the use of a combination of these therapy.

**METHODOLOGY**:

This open clinical trial will be conducted in Ayodhidoss pandithar hospital.The sample size is 30 patients of both sex within age limit of 3-12 years and they will be selected based on inclusion and exclusion criteria.

**RESULTS**:

Effectiveness of the trial drug will be assessed by measuring the reduction of clinical symptoms using modified ashwarth scale

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.Children of age group 3-12 years 2.
Weakness of one or more limbs 3.
Loss of power and tone in muscles of the affected limb 4.
Difficulty/ Inability in using the affected limb against gravity and resistance 5.
Difficulty in using the affected limb.

Exclusion Criteria

1.H/O Epilepsy 2.H/O Severe Aggressiveness with ADHD 3.H/O Autism 4.H/O Cerebral palsy 5.H/O Congenital Heart Disease 6.H/O Any other serious illness.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of Siddha regimen Inji chooranam (Internal) and Vathakesari Thylam (External) is measured by Modified aswarth scale for the management of Balavatham in children.	7 days once

Secondary Outcome Measures

Name	Time	Method
1. To standardize the physicochemical properties of the trial drugs as per PLIM guidelines.	2. Reduction in the recurrence of clinical symptoms

Trial Locations

Locations (1): Ayothidoss pandithar hospital
🇮🇳
Kancheepuram, TAMIL NADU, India
Ayothidoss pandithar hospital
🇮🇳Kancheepuram, TAMIL NADU, India
Dr E Elaveni
Principal investigator
9080460356
elavenie856@gmail.com