| CTRI Number |
CTRI/2025/07/092049 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"Effect of Two Ayurvedic Applications on scorpoin Bite:A Comparative Study" |
|
Scientific Title of Study
|
A Comparative Clinical Trial To Evaluate The Effect Of Paravathasakruthadi Lepa Against Sigrupunarnavadi Lepa In Vrishika Damsa. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidya K M |
| Designation |
PG Scholar |
| Affiliation |
MVR AYURVEDA MEDICAL COLLEGE |
| Address |
Department Of Agadathantra
MVR Ayurveda Medical College Parassinikadavu Kannur
SAME
Kannur
KERALA
670563
India |
| Phone |
9003242341 |
| Fax |
|
| Email |
123drvidya321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Jayasmitha S J |
| Designation |
Professer And HOD |
| Affiliation |
MVR AYURVEDA MEDICAL COLLEGE |
| Address |
Department Of Agadathantra
MVR Ayurveda Medical College
Parassinikadavu Kannur
Kannur
KERALA
670563
India |
| Phone |
8714498512 |
| Fax |
|
| Email |
dr.jayasmitha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidya K M |
| Designation |
PG Scholar |
| Affiliation |
MVR AYURVEDA MEDICAL COLLEGE |
| Address |
Department Of Agadathantra
MVR Ayurveda Medical College
Parassinikkadavu Kannur
Kannur
KERALA
670563
India |
| Phone |
9003242341 |
| Fax |
|
| Email |
123drvidya321@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SELF |
| Address |
PG Scholar,Department of agadathantra.
MVR Ayurveda medical College |
| 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 Vidya K M |
PAPPINISSERI VISHA CHIKITSA KENDRAM |
PG Department Of Agadathantra,MVR Ayurveda Medical College,Parassinikkadavu,Kannur,670563
Kannur
KERALA |
09003242341
123drvidya321@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MVR AYURVEDA MEDICAL COLLEGE PARASSINIKKADAVU INSTITUTIONAL ETHICAL 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 | Procedure | - | auShadham (viShopakramaH), औषधम् (विषोपक्रमः) | (Procedure Reference: ashtanga hrudaya, Procedure details: 2gm internally
)
(1) Medicine Name: paravathasakruthadi, Reference: prayogasamucchaya, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 0(NA), Frequency: tds, Duration: 5 Days(2) Medicine Name: dasangam gulika, Reference: ashtanga hrudayam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(g), Frequency: bd, Duration: 5 Days | | 2 | Comparator Arm | Procedure | - | auShadham (viShopakramaH), औषधम् (विषोपक्रमः) | (Procedure Reference: ASHTANGAHRUDAYAM, Procedure details: INTERNAL MEDICINE)
(1) Medicine Name: SIGRUPUNARNAVADI LEPAM, Reference: PRAYOGASAMUCHAYAM, Route: Topical, Dosage Form: Churna/ Powder, Dose: 0(NA), Frequency: tds, Duration: 5 Days(2) Medicine Name: DASNGA GULIKA, Reference: ASHTANGAHRUDAYAM, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(g), Frequency: tds, Duration: 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 History of Vrischika damsa within 48 hours
2Participants of age group 18-60 years, irrespective of gender, caste, religion, or economic status
3 Participants with any one or more of following symptoms pain, burning sensation, erythema, swelling
|
|
| ExclusionCriteria |
| Details |
Participants who have already undergone treatments for this condition.
1 Participants presenting complication like cardiac arrythmia, shock,
2 pregnant women and lactating mother.
3 Participants with chronic kidney disease.
• Participants aged below 18 years.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To analyze the effect of Paravathasakruthadi lepa on the management of vrischika damsa along with the internal administration of Dasanga agada.
To compare the effects of Paravathasakruthadi lepa against Sigrupunarnavadi lepa along with Dasanga agada in the management of vrischika damsa.
|
out come will be assessed at baseline day 3rd day 5th day .Final outcome measured at 18 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Paravathasakruthadi lepa against Sigrupunarnavadi lepa along with Dasanga agada internally in the vrischika damsa |
18 MONTHS |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
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
|
This comparative clinical study aims to evaluate the efficacy of paravathasakruthadi lepa against sigrupunarnavadi lepa with dasanga gulika administered internally in two groups of 20 participants each aged 18-60 years.the study duration is limited to 5days .after completion ,the results will be statisically analyzed to dertermine the comparative effectiveness of both treatments. |