| CTRI Number |
CTRI/2025/06/089318 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Medicated Paste for Local Application In Spider Bite |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Kottamramachadi Lepa In Loota Visha |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhiram R |
| Designation |
PG Scholar |
| Affiliation |
K V G Ayurveda Medical College and Hospital |
| Address |
Room No 3 Agadatantra OPD K V G Ayurveda Medical College and Hospital Ambate aka Sullia Dakshina Kannada District Karnataka state
Dakshina Kannada
KARNATAKA
574239
India |
| Phone |
9539257353 |
| Fax |
|
| Email |
abhiram994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash K V |
| Designation |
Professor and HOD |
| Affiliation |
K V G Ayurveda Medical College and Hospital |
| 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 |
9886937454 |
| Fax |
|
| Email |
avina138@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avinash K V |
| Designation |
Professor and HOD |
| Affiliation |
K V G Medical College and Hospital |
| 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 |
9886937454 |
| Fax |
|
| Email |
avina138@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| K V G Ayurveda Medical College and Hospital Ambate Adka Sullia D K District 574239 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Abhiram R |
| Address |
K V G Ayurveda Medical College and Hospital Ambate Adka Sullia DK District 574239 Karnataka |
| 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 Abhiram R |
K V G Ayurveda Medical College and Hospital |
Room No 3 Agadatantra OPD K V G Ayurveda Medical College and HospitalAmbate adka Sullia Dakshina Kannada District Karnataka India
Dakshina Kannada
KARNATAKA |
9539257353
abhiram994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Ayurveda Medical College and Hospital Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T633||Toxic effect of venom of spider. Ayurveda Condition: LUTAVISHA-ADHISHTHANAJANYAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kottamramachadi Lepa, Reference: Prayoga Sammuchayya, 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 |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of age between 16 to 60 years irrespective of gender society or socio economic status
2 Complaints of Loota Vista with three or more cardinal features
3 Cases of Loota Vista within a week after bite |
|
| ExclusionCriteria |
| Details |
1 Patients below 16 years of age and above 60 years of age will be excluded
2 Patients with any systemic disorders that can in some way alter the prognosis and treatment of Loota Vista
3 Patients with Aadhya Loota Damsa Lakshana
4 Patients afflicted with any other Poison
5 Patients taken treatment from any other branch of medicine
6 Patients who complain skin irritation after application of lepa
7 Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the following symptoms of Loota Damsha (spider bite) such as Shopha (swelling)Vedana(pain) Daha (Burning sensation)Raga(Discolouration) Jwara (Fever)Sphota ( Blisters) |
Assessed on time of starting treatment 1 st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Remission of symptoms of Loota Damsha such as Shopha Vedana Daha Raga Jwara |
7th 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)
|
01/07/2025 |
| 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 a shastra dealing with every aspect of life , focussing on well being and cure of diseases . Being a part of atharva veda and sacred in origin . Among the ashtanga of Ayurveda , Agada Tantra holds a special perspective in diagnosis , treatment and elimination of sthavara and jangama visa . Agada tantra explains in detail about Loota Vista belonging to Jangama vista , in Keetaloothadi vista pratisheda which is one of the detrimental poisoning seen nowadays . Loota visha is considered more dreadful than Keeta . More than 40,000 species of spider have been identified to date world wide. Loota Visha is selected as it is common in clinical practice of Agada Tantra. Loota emit poison through 8 routes such as breath , teeth , excreta , urine , saliva , semen , nails , menstrual blood. Lepa is an effective chikitsa coming under bahirparimarjana chikitsa and one among the chaturvimshati upakrama. Lepa helps to remove sthanika vista as well as prevent further spread of poison .
Our present study is to determine The efficacy of Kottamramachadi Lepa in Loota Visha Chikitsa. This yoga is mentioned in Loota Vista chikitsa of Prayoga Sammuchaya by Kocchuni Thamburan which is a dextrous text in Malayalam language dedicated for visa chikitsa .
Our treatment is scheduled for 7 days twice a day and assessment will bw on 8th day |