| CTRI Number |
CTRI/2025/03/081839 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Behavioral Other (Specify) [CURATIVE] |
| Study Design |
Other |
|
Public Title of Study
|
Clinical study on the combined effects of Mahathpanchagavya grita and abhyangam with Bhunagadi taila in treating intractable epilepsy along with antiepileptic medication in children aged 1-12 years. |
|
Scientific Title of Study
|
Combined effect of Mahathpanchagavya grita internally and abhyanga with Bhunagadi taila on specific areas of body as an add on to anti epileptic drug in the management of Intractable Epilepsy in Children of 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 |
Arya M |
| Designation |
First year MD scholar |
| Affiliation |
|
| Address |
Goverment Ayurveda College
Thiruvananthapuram
Thiruvananthapuram KERALA 695001 India |
| Phone |
9961775610 |
| Fax |
|
| Email |
draryamohandas@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sohini S |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Government Ayurveda College Thiruvananthapuram
Thiruvananthapuram KERALA 695001 India |
| Phone |
9447657471 |
| Fax |
|
| Email |
drsohini30@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sohini S |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Government Ayurveda College Thiruvananthapuram
Thiruvananthapuram KERALA 695001 India |
| Phone |
9447657471 |
| Fax |
|
| Email |
drsohini30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College
Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Goverment Ayurveda College Thiruvananthapuram |
| Address |
Government Ayurveda College
Thiruvananthapuram |
| Type of Sponsor |
Government medical college |
|
|
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 Arya M |
Goverment Ayurveda college Thiruvananthapuram For women and children Hospital Poojappura |
Department of Kaumarabhrthya
Thiruvananthapuram KERALA |
9961775610
draryamohandas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee Goverment 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: APASMARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahath Panchagavya Gritha, Reference: Ashtangahridaya Utharasthana, Route: Oral, Dosage Form: Ghrita, Dose: 200(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Bhunagadi Taila, Reference: Vaidyatharakam, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with intractable epilepsy.
2. Children aged 1-12 years.
3. On conventional AED unaltered for atleast 1 month as per the direction of paediatrc neurologist.
|
|
| ExclusionCriteria |
| Details |
1. Children with metabolic disorders
2. Children with recurrent respiratory tract infection.
3. Children with Developmental epileptic encephalopathy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| .Parental perception of seizure- frequency, intensity and severity of seizure will be assessed by using Hague seizure severity scale |
Hague seizure severity scale
before and after study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Electroencephalographic changes will be observed by Electroencephalogram.
3.Changes in quality of life will be assessed by Quality Of life in Childhood Epilepsy questionnaire
|
EEG
Questionnaire to assess the quality of life before and after the study |
|
|
Target Sample Size
|
Total Sample Size="14" Sample Size from India="14"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| 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
|
Children in the age group 1-12 years, satisfying inclusion criteria will be selected for the study from the OPD of Balaroga Government Ayurveda College Hospital for Women and Children, Poojappura. Informed consent will be taken from the parents of selected participants. Participants will be assessed using Hague seizure severity scale, EEG and quality of life in childhood epilepsy questionnaire. For this study drugs will be prepared as per classical references and will be made available from a GMP certified authorized Institution. The study participants will be given proper preperatory measures to make the participants fit for grita administration. Patient will be given Mahathpanchagavya grita for 60 days in a dose of 3-24ml according to age(calculated using Young’s formula), twice daily in empty stomach at morning and 1 hour before food in the evening with warm water. Abyangam on specific areas(Bregma,inbetween two eyebrows,behind ear,joints of upper and lower limb,palm of both hand,sole of both foot,site of Hridaya and nabhi) will be done twice daily(morning and evening) for a time period of 5 minutes for 60 days.After half an hour taila will be wiped off with clean towel .Participants will be adviced to take AEDs in same dose as they are taking throughout the study. Participants will be assessed before treatment, after treatment and after follow up period using Hagues seizure severity scale. quality of life in childhood epilepsy questionnaire, and EEG. Parents will be instructed to keep a seizure diary also .EEG of the child will be taken before and after study from near by authorized scan centre and will be assessed by co-guide of the study (Paediatric Neurologist.) |