| CTRI Number |
CTRI/2024/04/065579 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| 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
|
Role of Ayurveda Herbo-mineral (with gold) tablets in Myoclonic Epilepsy in children |
|
Scientific Title of Study
|
A clinical study on Aurokid Plus tablet as adjuvant therapy in the management of pediatric Myoclonic Epilepsy - A proof of concept |
| 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. Priyal Patel |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Kaumarbhritya, OPD number 103, Parul Ayurved Hospital, Parul University, Limda, Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9998810088 |
| Fax |
|
| Email |
priyal26599@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Swapnil C.R. |
| Designation |
Professor and Head |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Kaumarbhritya, OPD Number 103, Parul Ayurved Hospital, Parul University, Limda, Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9726587013 |
| Fax |
|
| Email |
neonatecare97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SWAPNIL CR |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
PARUL INSTITUE OF AYURVED |
| Address |
OPD Number 103 Parul Ayurved Hospital Parul University Limda Waghodia
GUJARAT
391760
India |
| Phone |
9726587013 |
| Fax |
|
| Email |
neonatecare97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul University Limda Vadodara Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Parul University |
| Address |
Parul University At Post Limda Waghodia Vadodara Gujarat 391760 |
| 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 Priyal Patel |
Parul Ayurved Hospital |
Department of Kaumarbhritya OPD Room number 103 Parul Ayurved Hospital Parul University Limda Waghodia
Vadodara
GUJARAT |
09998810088
priyal26599@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Parul Institute of Ayurved Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G40B||Juvenile myoclonic epilepsy [impulsive petit mal]. Ayurveda Condition: APASMARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Sodium Valproate | 15mg/kg/day in divided 2 doses for 60 days | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: AUROKID PLUS, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Saraswatarishtam), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Childhood ME and its type
Prediagnosed cases
minimum chronicity 6 months and less than 5 years |
|
| ExclusionCriteria |
| Details |
Acute and Chronic systemic diseases
episodes of 2 or more status epilepticus in last 6 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement on Cognition on the basis of Binnet Kamat Scale and MMAS |
day 30 and day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Quality of life on basis WHO QoL Questioner 55 |
day 30 & day 60 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 |
|
Date of First Enrollment (India)
|
22/04/2024 |
| 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
|
Myoclonic epilepsy is neurobehavioral disorder affectinf tje cognition of child with social stigma. Ayurveda having multiple herbomineral drug to improve the cognitionand to improve the quality of life of children with epilepsy, Aurokid Plus is special gold salt Ayurveda Proprietory medicine used in childhood neurobahvioral diseases. Present study is aiming towards to evaluate the effect of tablet as an adjuvant therapy in childhood myoclonic epilepsies |