| CTRI Number |
CTRI/2023/06/053514 [Registered on: 05/06/2023] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [Internal medicine and external therapy] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Injii chooranam Along with Vathakesari thylam For Balavatham in children |
|
Scientific Title of Study
|
An open non randomized single Arm single centric clinical Trial to evaluate the Effectiveness of Inji Chooranam(Internal) and Vathakesari thylam(external) in the management of Balavatham in Children |
| Trial Acronym |
Balavatham,Inji chooranam, |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr E Elaveni |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Siddha |
| Address |
Room no 9,Department of Kuzhandhai Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Kancheepuram,
TAMIL NADU,
Chennai_47,
India
Sri Ganesha nagar, Maharajapuram Housing board opposite, East pondy road, Villupuram,
PIN- 605602
Viluppuram
TAMIL NADU
600047
India |
| Phone |
9080460356 |
| Fax |
|
| Email |
elavenie856@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Meenakshi Sundaram MDS PhD |
| Designation |
Professor |
| Affiliation |
National Institute Of Siddha |
| Address |
Room no 9,Department of Kuzhandhai Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Kancheepuram,
TAMIL NADU,
Chennai_47,
India
National Institute of Siddha,Tambaram Sanatorium,Kancheepuram,
TAMIL NADU,
Chennai_47,
India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
|
| Email |
mmssiddha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrEElaveni |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Siddha |
| Address |
Room no 9,Department of Kuzhandhai Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Kancheepuram,
TAMIL NADU,
Chennai_47,
India
Sri ganesha nagar,maharajapuram housing board opp,East pondy road,villupuram district,
pin:605602
Viluppuram
TAMIL NADU
Dr E Elaveni
India |
| Phone |
09080460356 |
| Fax |
|
| Email |
elavenie856@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,Tambaram sanatorium,Chennai - 47 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Siddha |
| Address |
Ayothidoss Pandithar Hospital,National institute of Siddha,Tambaram Sanatorium,Chennai |
| 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 E Elaveni |
Ayothidoss pandithar hospital |
National Institute of Siddha,
Tambaram Sanatorium,
Kancheepuram,
TAMIL NADU,
Chennai_47,
India
Kancheepuram
TAMIL NADU |
9080460356
elavenie856@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional Ethics Committee,National Institute Of Siddha, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INJI CHOORANAM(INTERNAL)
VATHAKESARI THYLAM(EXTERNAL) |
INTERNAL MEDICINE:Frequency: Twice a day Adjuvant: hot water, Dosage:3-4years - 375 mg
5-7 years - 552 mg
8-12 years -750 mg
Duration:48 days
EXTERNAL MEDICINE:Required quantity to be applied for thokkanam |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
1. To standardize the physicochemical properties of the trial drugs as per PLIM guidelines.
2. Reduction in the recurrence of clinical symptoms
|
7 days once |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/06/2023 |
| Date of Study Completion (India) |
11/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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
|