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CTRI Number  CTRI/2023/04/051329 [Registered on: 05/04/2023] Trial Registered Prospectively
Last Modified On: 03/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of a herbal formulation in insect stings and bites 
Scientific Title of Study   Clinical trial on Efficacy of Erithaila in the Management of Stings and Bites 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anupama B 
Designation  Final year BAMS Student 
Affiliation  KERALA UNIVERSITY OF HEALTH SCIENCES 
Address  Nangelil Ayurveda Medical College, Nellikuzhi P.O, Kothamangalam,Ernakulam District,Kerala-686691
Nangelil Ayurveda Medical College, Nellikuzhi P.O, Kothamangalam,Ernakulam District,Kerala-686691
Ernakulam
KERALA
686691
India 
Phone  9188799414  
Fax    
Email  anupamabshenoy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrDeepa George 
Designation  Associate Professor,Department Agadatantra 
Affiliation  KERALA UNIVERSITY OF HEALTH SCIENCES 
Address  Associate Professor,Department Agadatantra,Nangelil Ayurveda Medical College, Nellikuzhi P.O,Kothamangalam,Ernakulam Dist.,Kerala-686691

Ernakulam
KERALA
686691
India 
Phone  9895383727  
Fax    
Email  deepadiya70@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrDeepa George 
Designation  Associate Professor,Department Agadatantra 
Affiliation  KERALA UNIVERSITY OF HEALTH SCIENCES 
Address  Associate Professor,Department Agadatantra,Nangelil Ayurveda Medical College, Nellikuzhi P.O,Kothamangalam,Ernakulam Dist.,Kerala-686691

Ernakulam
KERALA
686691
India 
Phone  9895383727  
Fax    
Email  deepadiya70@gmail.com  
 
Source of Monetary or Material Support  
Nangelil Ayurveda Medical College, Nellikuzhi P.O, Kothamangalam,Ernakulam District,Kerala-686691 
 
Primary Sponsor  
Name  Nangelil Ayurveda Medical College, Nellikuzhi P.O, Kothamangalam,Ernakulam District,Kerala-686691 
Address  Nangelil Ayurveda Medical College, Nellikuzhi P.O, Kothamangalam,Ernakulam District,Kerala-686691 
Type of Sponsor  Private 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 
DrDeepa George  Nangelil Ayurveda Medical College Hospital,Kothamangalam  Department of Agadatantra
Ernakulam
KERALA 
9895383727

deepadiya70@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nangelil Ayurveda Medical College Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:S00-T88||Injury, poisoning and certain other consequences of external causes. Ayurveda Condition: JANGAMAVISHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Erithaila, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 1(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Erithaila is applied topically over the site of insect sting or bite for first 7 days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients within 20-60yearsirrespective of sex.
Undrestood and voluntarily agreed to participatein this study. 
 
ExclusionCriteria 
Details  1.Patients of age less than 20 and more than 60
2.Pregnancy
3.Uncontrolled Diabetes
4.Patients with history of other systemic disorders 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
pain
itching
swelling
burning sensation 
1st,3rd and 5th day  
 
Secondary Outcome  
Outcome  TimePoints 
Erythema
WBC
ESR 
1st and 5th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 
Date of First Enrollment (India)   20/04/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/04/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
’Erithaila’ is a folk medicine that has been in use since many years. The efficacy of this remains unauthorized. ’Erithaila’ which consist of both plant origin & Non-plant origin ingredients is prepared in a similar way as that of दीपिकातलै which mentioned in Brhtrayis. Preparation is made by igniting the medicines & extracting its contents in the form of oil. The study focuses on emphasizing the efficacy of this medicine in clinical practice, especially in general toxicology. Proper documentation of its administration & effects proves to be significant.
This research is done to empower the diminishing power of medicine used by ancient Vishavaidyas along with the modern ayurvedic perspective to widen the viewpoint of clinical practice. Stings & bites are common problems faced by people. The aim of the study is preparation of Erithaila & its topical application on selected Patients with stings & bites.
This is a pre & post test study with 30 patients of both sex having stings and bites of an average age limit 20-60 years. Fulfilling the criteria, for the diagnosis of disease will be registered for the present study according to inclusion criteria. The patient will be selected from the OPD & IPD of Dept. of Agadatantra, Nangelil Ayurveda Medical college, Kothamangalam, Ernakulam. A single drop of erithaila is applied externally over the site of infliction twice a day.Subjective & objective parameters before & after treatment will be recorded meticulously & analyzed by using appropriate Stastical methods.
 
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