| CTRI Number |
CTRI/2022/10/046109 [Registered on: 03/10/2022] Trial Registered Prospectively |
| Last Modified On: |
22/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [TREATMENT] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An Ayurvedic management of scorpion sting with external and internal medicine |
|
Scientific Title of Study
|
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 Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shanti R Nair |
| Designation |
Phd Scholar |
| Affiliation |
Parul Institute Of Ayurveda/MVR Ayurveda Medical College Parassinikkadavu |
| Address |
Parul Institute of Ayurveda,Department of Agada Tantra- Room no; 9, OPD no;6, Parul University, p.o limda, ta.waghodia, dist, Vadodara
Parul Institute of Ayurveda,Department of Agada Tantra- Room no; 9, OPD no;6, Parul University, p.o limda, ta.waghodia, dist, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9510379038 |
| Fax |
|
| Email |
shantirnair27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suwarna Akashdeep Meshram |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
Parul Institute of Ayurveda,Department of Agada Tantra- Room no; 9, OPD no;6, Parul University, p.o limda, ta.waghodia, dist, Vadodara
Parul Institute of Ayurveda,Department of Agada Tantra- Room no; 9, OPD no;6, Parul University, p.o limda, ta.waghodia, dist, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9890889204 |
| Fax |
|
| Email |
suwarna.meshram86231@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shanti R Nair |
| Designation |
Phd Scholar |
| Affiliation |
Parul Institute Of Ayurveda/MVR Ayurveda Medical College Parassinikkadavu |
| Address |
Parul Institute of Ayurveda,Department of Agada Tantra- Room no; 9, OPD no;6, Parul University, p.o limda, ta.waghodia, dist, Vadodara
Parul Institute of Ayurveda,Department of Agada Tantra- Room no; 9, OPD no;6, Parul University, p.o limda, ta.waghodia, dist, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9510379038 |
| Fax |
|
| Email |
shantirnair27@gmail.com |
|
|
Source of Monetary or Material Support
|
| MVR Ayurveda Medical College Parassinikkadavu |
|
|
Primary Sponsor
|
| Name |
Dr Shanti R Nair |
| Address |
Parul Institute of Ayurveda,Department of Agada Tantra- Room no; 9, OPD no;6, Parul University, p.o limda, ta.waghodia, dist, Vadodara |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shanti R Nair |
MVR Ayurveda Medical College |
Pappinishery Visha Chikitsa Kendram, OPD; 18, Department of Agada Tantra, room no; 6
Kannur
KERALA |
9510379038
shantirnair27@gmail.com |
| Dr Shanti R air |
Parul Institute of Ayurveda |
Department of Agada Tantra- Room no; 9, OPD no;6, Parul University, p.o limda, ta.waghodia, dist, Vadodara
Vadodara
GUJARAT |
9510379038
shantirnair27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
| 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: VISHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | tailadhArA, तैलधारा | (Procedure Reference: Ashtanga Hrudayam, Procedure details: In group B diagnosed case of Vrischika damasha will be administered with 200ml of Ghrita Saindhava dhara, dhara will be for one hour for two day, along with internal administration of Dasanga gulika 2gm TDS, with hot water.)
(1) Medicine Name: Ghrita Saindhava , Reference: Ashtanga Hrudayam, Route: Topical, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 2 Days | | 2 | Intervention Arm | Procedure | - | tailadhArA, तैलधारा | (Procedure Reference: Kriya Kaumadi, Procedure details: In group A diagnosed case of vrischika damsha will be administered with 200ml of shaliparni thaila dhara the dhara will be done for one hour for two day,along with internal administration of dasanga gulika 2gm TDS with hot water )
(1) Medicine Name: Shaloparni thaila, Reference: Kriyakoumudi, Route: Topical, Dosage Form: Taila, Dose: 200(ml), Frequency: od, Duration: 2 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Diagnosed case of scorpion bite within 48hrs.
2) 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
|
|
| ExclusionCriteria |
| Details |
1) 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
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ordinal scale will be analysed for symptoms before and after the treatment |
For 3 days (on day 1, day2 and 4th day of treatmnt),Ordinal scale will be analysed for symptoms |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vas scale for pain |
For 3 days (on day 1, day2 and 4th day of treatmnt),VAS scale will be analysed for pain |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/10/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/09/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Scorpion
sting being a major public health problem is an acute life threatening , time
limiting medical emergency especially in rural parts of India .Though the
annual incidence rate of scorpion sting
cases 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 are
readily unavailable as it is a common rural accident
and many envenomations go unreported. The main factors responsible for high
mortality 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 where
vegetation are often dense also in humid, sub tropical to tropical climate.
Commonly used drug in vrischika damsha is Dasanga
agadam but the internal use of this drug is not sufficient to
manage the overall symptoms produced by the scorpion sting so we have to use some
external application also to manage the situation. In this Saliparni taila dhara mentioned in kriyakoumudi
chapter keetadi prakarnam is not
popularly used by the
practitioners. However saliparni is
considered to be vishaghna. Hence it can be tried as a vishaghna aushada in
vrishchika visha damsha.
Saliparni thaila dhara is left as secret with some
traditional vaidyas and as it is in regional language Malayalam to make it
universal this research is a need of the hour.
As Agada
tantra is losing its clinical practice due to urbanization so these studies
must be done to prove still cases are available and the management is pure
ayurveda.
Practitioners
widely use gritha saindava dhara in their clinical practice which
has not shown result in overall management of vrischika visha so the drug
shaliparni dhara which has shown result in the management of scorpion sting
must be compared and brought in to light to the clinical practice.
In this study an attempt is made to carry out
a comparative clinical study of Saliparni
taila dhara against gritha saindava dhara along with the internal administration
of Dasanga agada to provide an
evidence based formulation for its acute management in common agada practice. Null Hypothesis:-
·
Saliparni thaila dhara along with dasanga agada is less
effective than Gritha saindava dhara in the management of vrischika visha.
Research
Hypothesis:-
·
Saliparni thaila dhara along with dasanga agada is equal or more effective than
gritha saindava dhara in management of vrishchika damsha. |