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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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.)


 
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