| CTRI Number |
CTRI/2025/03/082788 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [developmental quotient] |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to evaluate the effectiveness of internal administration of Vilwa panchanga gritham and external application of Dhanwantharam thailam as abhyangam in children with encephalapathy of the age group 1-12 years in a sample size of 22 |
|
Scientific Title of Study
|
To evaluate the effect of Vilwa panchanga gritham internally and Dhanwanthara Thailam Abhyangam as an add on to Anti-epileptic medication in children with Developmental and Epileptic encephalopathies of the age group 1-12 years |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
APARNA PRASAD |
| Designation |
2nd year P G scholar |
| Affiliation |
Government Ayurveda college Thiruvananthapuram |
| Address |
Department of Kaumarabhritya
Women and Children hospital poojapura
Government Ayurveda college Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India |
| Phone |
8714120771 |
| Fax |
|
| Email |
aparnavysakh2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roshni Anirudhan |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda college Thiruvananthapuram |
| Address |
Department of Kaumarabhritya
Women and Children hospital poojapura
Government Ayurveda college Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9447006585 |
| Fax |
|
| Email |
doctoroshni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
APARNA PRASAD |
| Designation |
2nd year P G scholar |
| Affiliation |
Government Ayurveda college Thiruvananthapuram |
| Address |
Department of Kaumarabhritya
Women and Children hospital poojapura
Government Ayurveda college Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India |
| Phone |
8714120771 |
| Fax |
|
| Email |
aparnavysakh2018@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVT Ayurceda college Thiruvananthapuram Women and Children hospital poojapura
PIN 695012
KERALA |
|
|
Primary Sponsor
|
| Name |
Dr Aparna prasad |
| Address |
Department of Kaumarabhrithya
Government ayurveda college Thiruvananthapuram
Women and Children hospital poojapura
PIN 695012
Kerala India |
| Type of Sponsor |
Other [self] |
|
|
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 Aparna prasad |
Government Ayurveda College Thiruvananthapuram Women and Children hospital poojapura |
Department of Kaumarabhritya
OP NO 1 new building women and children hospital poojapurra,Government Ayurveda college Thiruvananthapuram
Women and Children hospital poojapura
Thiruvananthapuram
KERALA |
08714120771
aparnavysakh2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Ayurveda college Thiruvananthapuram (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F068||Other specified mental disorders due to known physiological condition. Ayurveda Condition: SANNIPATAJA-APASMARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: dhanwantharam thailam, Reference: ashtanga hridayayam sarira 2nd chapter, Route: Topical, Dosage Form: Taila, Dose: 200(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: dhanwantharam thailam, Reference: ashtanga hridayam sariram, Route: Topical, Dosage Form: Taila, Dose: 200(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: vilwa panchanga gritham, Reference: arogya kalpa drumam 32 chapter Apasmara chikitsa sloka 4 and 5, Route: Oral, Dosage Form: Ghrita, Dose: 200(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of Developmental and epileptic encephalopathies of age group 1-12 years.
On Conventional AED unaltered for at least 1 month as per the direction of Pediatric neurologist
|
|
| ExclusionCriteria |
| Details |
History of recurrent lower respiratory tract infections.
Metabolic disorders and neurodegenerative disorders.
The exclusion is based on clinical features, history of illness along with available investigation reports
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in seizure severity assessed using Hague seizure severity scale and developmental quotient by GMFM |
Seizure severity assessed using HAQUE SEIZURE SEVERITY SCALE and developmental quotient by GMFM before treatment and after 3 month administration of medications and after one month follow up
GMFM |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Analysis & behavioural by VABS.
|
Behavioural assessement before treatment after 3 months of medication & after one month follow up |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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
|
Participants of the age group 1-12 years satisfying the inclusion criteria attending the OPD of the department of kaumarabhrithya govt ayurveda college hospital for women and children, poojappura will be taken for the study . After doing the initial assessments, subjects in the study participants gritha will be giving(3-20ml) depending upon the age and weight of the child. Abhyangam with dhanwantharam thailam over head and body in the morning for 90 days with 30 mints duration After abhyangam head and body washed using luke warm water and rasnadi choornam dusted over bregma.the study participants is continued with Antiepileptic medications. The participants are assessed after study and follow up period using internationally accepted tools such as Haque seizure scale , GMFM, VABS. |