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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Other 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. |