| CTRI Number |
CTRI/2025/07/090980 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Medicinal paste application in scorpion bite. |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy of Jeerakadi Lepa in Vrishchika Damsha. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreya Sachin Chougule |
| Designation |
PG Scholar |
| Affiliation |
K V G Ayurveda Medical College and Hospital sullia |
| Address |
Room no 3 Agadatantra OPD K V G Ayurveda Medical College and Hospital Ambate adka Sullia Dakshina Kannada District Karnataka State
Dakshina Kannada
KARNATAKA
574239
India |
| Phone |
7676122645 |
| Fax |
|
| Email |
shreyasc1408@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leeladhara DV |
| Designation |
Principal K V G Ayurveda Medical College and Hospital |
| Affiliation |
K V G Ayurveda Medical College and Hospital Sullia |
| Address |
Room no 3 Agadatantra OPD K V G Ayurveda Medical College and Hospital Ambate adka Sullia Dakshina Kannada District Karnataka State
Dakshina Kannada
KARNATAKA
574239
India |
| Phone |
7353756060 |
| Fax |
|
| Email |
drleeladhara_dv@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Leeladhara DV |
| Designation |
Principal K V G Ayurveda Medical College and Hospital |
| Affiliation |
K V G Ayurveda Medical College and Hospital Sullia |
| Address |
Room no 3 Agadatantra OPD K V G Ayurveda Medical College and Hospital Ambate adka Sullia Dakshina Kannada District Karnataka State
Dakshina Kannada
KARNATAKA
574239
India |
| Phone |
7353756060 |
| Fax |
|
| Email |
drleeladhara_dv@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| K V G Ayurveda Medical College and hospital Ambate adka,sullia Dakshina Kannada,Karnataka, India Pin : 574327 |
|
|
Primary Sponsor
|
| Name |
Shreya Sachin Chougule |
| Address |
K V G Ayurveda Medical College and Hospital Sullia |
| Type of Sponsor |
Other [self] |
|
|
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 Shreya Sachin Chougule |
K V VG Ayurveda Medical College and Hospital Sullia |
room no 3 agadatantra OPD K V G Ayurveda medical college sullia
Dakshina Kannada
KARNATAKA |
7676122645
shreyasc1408@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T632||Toxic effect of venom of scorpion. Ayurveda Condition: VRUSCIKAVISHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jeerakadi lepa, Reference: Bhavaprakash Nigantu, Route: Topical, Dosage Form: Lepa Churna, Dose: 50(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients irrespective of sex , religion , socio-economic status having age between 16-65 years.
2.Patients with history of scorpion sting. |
|
| ExclusionCriteria |
| Details |
1.Patients below age of 16 years of age.
2.Patients suffering from other systemic diseases that interfere with prognosis and management of scorpion sting.
3.Patients who have undergone any other treatment for same complaint.
4.Patients with other toxic bites.
5.Patients of vrishchika visha with asadhya lakshana.
6.Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the following symptoms of vrishchika damsha such as Daha, Ruk, Toda, Sphota |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| remission of symptoms like daha, ruk, toda & sphota |
1 week |
|
|
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)
|
26/07/2025 |
| 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="0"
Months="3"
Days="15" |
|
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
|
ayurveda is one of renowned traditional systems of medicine. It deals with maintaining the health of healthy individuals and curing the disease of patients. among ashtanga, agadatantra stands separate in its concept, clinical approach, management and result. according to source of origin visha is divided into two types i.e, sthavara and Jangama. Among Jangama Visha, Keeta Visha forms the major category due to the wide variety of species and their distribution pattern. Vrischika is considered among keeta visha. Daha, Toda, Ruk and Kandu are the main symptoms of Vrischika damsha.
Jeerakadi lepa is one of the formulations mentioned in Bhavapraksha which has significant effect on above mentioned symptoms.
Jeerakadi lepa is administered externally to 30 patients presented with symptoms of vrischika damsha and assessment is done on 3rd and 8th day of the treatment. |