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CTRI Number  CTRI/2023/01/048959 [Registered on: 12/01/2023] Trial Registered Prospectively
Last Modified On: 29/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study to Evaluate the Safety and Efficacy of Hemp Seed Oil in Epilepsy Management 
Scientific Title of Study   An Open Label Clinical Study to Evaluate the Safety and Efficacy of Hemp Seed Oil 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NH/HSE/1122, Version 1.0 Dated 01 November 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SSVV Narasinga Rao 
Designation  M.D., General Medicine 
Affiliation  Government Medical College and Government General Hospital 
Address  Room No 4, Ground Floor Department of Medicine, OPD Block, Government Medical College and Government General Hospital

Srikakulam
ANDHRA PRADESH
532001
India 
Phone  9912320517  
Fax    
Email  drnarasingaraossvv@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Harshavardhan Reddy Sirupa 
Designation  Managing Director 
Affiliation  Namrata Hempco Limited 
Address  Room no 1, Ground Floor, 772, 7th cross, sector-1, HSR Layout

Bangalore
KARNATAKA
560102
India 
Phone  8792193978  
Fax    
Email  harsha@nhempco.com  
 
Details of Contact Person
Public Query  
Name  Mr Harshavardhan Reddy Sirupa 
Designation  Managing Director 
Affiliation  Namrata Hempco Limited 
Address  Room no 1, Ground Floor, 772, 7th cross, sector-1, HSR Layout

Bangalore
KARNATAKA
560102
India 
Phone  8792193978  
Fax    
Email  harsha@nhempco.com  
 
Source of Monetary or Material Support  
Namrata Hempco Limited 772, 7th cross, sector-1, HSR Layout, Bangalore, Karnataka, 560102.  
 
Primary Sponsor  
Name  Namrata Hempco Limited 
Address  772, 7th cross, sector-1, HSR Layout, Bangalore, Karnataka, 560102 
Type of Sponsor  Other [Nutraceutical Company] 
 
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 S S V V Narasinga Rao  Government Medical College & Government General Hospital  Department of General Medicine, Room No 4, Ground Floor, OPD Block
Srikakulam
ANDHRA PRADESH 		 8942279033

drnarasingaraossvv@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Government Medical College & Government General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G409||Epilepsy, unspecified. Ayurveda Condition: APASMARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Hemp Seed Oil, Reference: NA, Route: Oral, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 180 Days, anupAna/sahapAna: No, Additional Information: Subjects shall be administered with 5 ml of Hempseed oil twice daily for 180 days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Male and female subjects with epilepsy history, ranging in age from 18 to 45 years.
2.Willingness to follow the protocol requirements as evidenced by written, informed consent.
3.Mentally, physically and legally eligible to give informed consent
4.Willingness to complete study questionnaires
 
 
ExclusionCriteria 
Details  1.Patients with pre-existing other severe systemic disease necessitating long-term medication.
2.Significant medical or psychiatric illness
3.History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ
4.Any vascular or systemic disorder which could affect any of the efficacy assessments
5.Participation in the current or previous treatment with any approved or investigational health supplement(s) during the past 1 month
6.Subjects received other medication (anti-viral) within the 36 hours before entry into the study
7.Patients who had immunization against influenza or influenza like illnesses for that season.
8.Inability to comply with the study protocol, including psychiatric diseases
9.Immune compromised or with other clinically active illness including cardiac or pulmonary diseases, hemoglobinopathies, renal dysfunction
10.Having vaccination of a seasonal or new influenza A (H1N1) vaccine 6 months before
11.Other reasons that researchers think not fitting to participate in the study
12.Evidence of significant uncontrolled comorbid disease which in the investigator opinion would jeopardize patient participation
13.Patient tested positive with Covid 19 
 
Method of Generating Random Sequence    
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change from Baseline to End of the Study in the Electroencephalogram Spike Activity  Day 0, Day 21, Day 42, Day 90, Day 120, Day 180 
 
Secondary Outcome  
Outcome  TimePoints 
Number of attacks before and after treatment  Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180 
Time to recover after onset of seizures  Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180 
Percentage of patients reduced the attacks to nil by the end of the treatment period  Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180 
Incidence of adverse events (AEs)  Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180 
SGA/PGA   Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   16/01/2023 
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="0"
Months="9"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is an open label single arm clinical study to evaluate the safety and efficacy of hemp seed oil in treating the epilepsy. The eligible subjects shall be administered with the 10 ml of hemp seed oil (5 ml in the morning and 5 ml in the night) everyday for 180 days.  
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