A COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF SALIPARNI THAILA DHARA(PSEUDARTHRIA VISCIDA LINN) AGAINST GRITHA SAINDAVA DHARA IN THE MANAGEMENT OF VRISCHIKA DAMSHA (SCORPION STING)
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Ordinal scale will be analysed for symptoms before and after the treatment
Study Overview
Brief Summary
Scorpionsting being a major public health problem is an acute life threatening , timelimiting medical emergency especially in rural parts of India .Though theannual incidence rate of scorpion stingcases in India exceeds 1.23 million, in which over 32,250 are fatal. In Asia,epidemiological data on scorpion stings is scarce. India is the most affected,with a reported incidence of 0.6% yet reliable statistics arereadily unavailable as it is a common rural accidentand many envenomations go unreported. The main factors responsible for highmortality are poor health services, difficult and untimely transportation facilities,wrong traditional belief and delay in anti scorpion venom administration.Scorpion sting are mostly seen in rainy season during night in rural area wherevegetation are often dense also in humid, sub tropical to tropical climate.
Commonly used drug in vrischika damsha is Dasangaagadam but the internal use of this drug is not sufficient tomanage the overall symptoms produced by the scorpion sting so we have to use someexternal application also to manage the situation. In this Saliparni taila dharamentioned in kriyakoumudichapter keetadi prakarnam is notpopularly used by thepractitioners. However saliparni isconsidered to be vishaghna. Hence it can be tried as a vishaghna aushada invrishchika visha damsha.
Saliparni thaila dhara is left as secret with sometraditional vaidyas and as it is in regional language Malayalam to make ituniversal this research is a need of the hour.
As Agadatantra is losing its clinical practice due to urbanization so these studiesmust be done to prove still cases are available and the management is pureayurveda.
Practitionerswidely use gritha saindava dhara in their clinical practice whichhas not shown result in overall management of vrischika visha so the drugshaliparni dhara which has shown result in the management of scorpion stingmust be compared and brought in to light to the clinical practice.
In this study an attempt is made to carry outa comparative clinical study of Saliparnitaila dhara against gritha saindava dhara along with the internal administrationof Dasanga agada to provide anevidence based formulation for its acute management in common agada practice.
Null Hypothesis:-
· Saliparni thaila dhara along with dasanga agada is lesseffective than Gritha saindava dhara in the management of vrischika visha.
ResearchHypothesis:-
· Saliparni thaila dhara along with dasanga agada is equal or more effective thangritha saindava dhara in management of vrishchika damsha.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 16.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diagnosed case of scorpion bite within 48hrs.
- •Participants with essential symptoms like pain, swelling, burning sensation, erythema 3) Participants with sting mark on body 4) Participants irrespective of gender, caste, region & economic status.
Exclusion Criteria
- •Patients who have already undergone any treatment for this condition 2) Patients having complication like altered sense of consciousness, like coma, convulsions and signs of neuropathy 3) Patients with other skin lesions at the site of bite 4) Pregnant women & lactating mother 5) Participants with systemic diseases like DM, HTN &other systemic disorders.
Outcomes
Primary Outcomes
Ordinal scale will be analysed for symptoms before and after the treatment
Time Frame: For 3 days (on day 1, day2 and 4th day of treatmnt),Ordinal scale will be analysed for symptoms
Secondary Outcomes
- Vas scale for pain(For 3 days (on day 1, day2 and 4th day of treatmnt),VAS scale will be analysed for pain)