CTRI Number |
CTRI/2021/03/031915 [Registered on: 11/03/2021] Trial Registered Prospectively |
Last Modified On: |
10/03/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
AYURVEDIC MANAGEMENT FOR SHEETAPITTA (URTICARIA) |
Scientific Title of Study
|
“A COMPARATIVE CLINICAL STUDY ON VIRECHANA AND SIRAVYADHA IN THE MANAGEMENT OF SHEETAPITTA W.S.R URTICARIA |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ramya L |
Designation |
PG Scholar |
Affiliation |
Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal |
Address |
Room no 05 , Department of panchakarma ,Shree Jagadguru Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal
Koppal KARNATAKA 583231 India |
Phone |
7848964077 |
Fax |
|
Email |
ramyaparichaya@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Manjunath Akki |
Designation |
Professor and Guide |
Affiliation |
Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal |
Address |
Room no 05 , Department of panchakarma ,Shree Jagadguru Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal
Koppal KARNATAKA 583231 India |
Phone |
8123044125 |
Fax |
|
Email |
drmanju78@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Manjunath Akki |
Designation |
Professor and Guide |
Affiliation |
Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal |
Address |
Room no 05 , Department of panchakarma ,Shree Jagadguru Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal
Koppal KARNATAKA 583231 India |
Phone |
8123044125 |
Fax |
|
Email |
drmanju78@gmail.com |
|
Source of Monetary or Material Support
|
shree jagadguru gavisiddeshwara ayurvedic medical college and research center gavimutt koppal |
|
Primary Sponsor
|
Name |
Shree Jagadguru gavisidheswara ayurvedic medical college postgraduate studies and research centre |
Address |
Room 05 DEPT Of Panchakarma Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal 583231 Karnataka Koppal KARNATAKA 583231 India
|
Type of Sponsor |
Research institution and hospital |
|
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 Ramya L |
Shree Jagadguru gavisidheswara ayurvedic medical college postgraduate studies and research centre |
Room 05 ,Department of panchakarma ,Shree Jagadguru gavisidheswara ayurvedic medical college postgraduate studies and research centre Koppal
Koppal
KARNATAKA Koppal KARNATAKA |
7848964077
ramyaparichaya@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL CLINICAL ETHICAL COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: SITAPITTAM, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Siravyadha |
sadyo sneha with Mahatiktakaghrita orally 70ml , followed by siravyadha with scalp vein set |
Intervention |
Virechana with Triphaladi kwatha |
Virechana kashaya orally dose- 80ml once , snehapana with Mahatiktaka
Ghrita orally 1st day -30ml, 2nd day -60ml ,3rd day -90ml |
|
Inclusion Criteria
|
Age From |
15.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
1 Patient fulfilling the diagnostic criteria
2 Patients between the age group of 15 to 45 years of either sex
3 Patients who are fit for Virechana and Siravyadha Karma
4 Patients suffering with Sheetapitta for more than 6 weeks to 10 years.
|
|
ExclusionCriteria |
Details |
1 Patients with other systemic disorder which interfere with the course of the treatment
2 Rashes and other symptoms which is produced by insect bite
3 Sheetapitta of acute onset.
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
absence of Varatidamstrasamsthanasotha ( Rashes like insect bite mark),Toda (Pricking Pain),Daha (burning sensation ),Kandu (itching sensation )
|
28 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
complete absence of absence of Varatidamstrasamsthanasotha ( Rashes like insect bite mark),Toda (Pricking Pain),Daha (burning sensation ),Kandu (itching sensation )
absence of Varatidamstrasamsthanasotha ( Rashes like insect bite mark),Toda (Pricking Pain),Daha (burning sensation ),Kandu (itching sensation ) |
28 days |
|
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 2 |
Date of First Enrollment (India)
|
15/03/2021 |
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="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
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
|
Sheetapitta is one among the skin disease,
and it is Vatapradhanavyadhi. Hence the pain is more in Sheetapitta and
produces symptoms like rashes as like of insect bite, itching sensation…etc.1
According
to Classical references, Sheetapitta is having sign and symptoms as
VaratiDamstraSamsthana (rashes like insect bite),Shopha (papular rashes) ,Kandu
(itching), Toda (pricking pain) …etc.2 3
As mentioned in classics, nidanas
are exposure to cold wind, Vega Avrodha and other factors which causes
vitiation of Kapha and Vata, which in turn vitiates Pitta ,Rakta and produces
rash on the skin which is called as Sheetapitta.4
Sheetapitta is the commonest disease
which occurs frequently with a life time; globally prevalence of the disease is
around 8.8%.Usually prevalence is more in females than males. In terms of age
20-30 year old are more affected by the disease. In India 20 to 30% population are
suffering from this disease.5
Sheetapitta
can be correlated to Urticaria and it is characterized by a sudden general
eruption of pale wheals or papules, which are associated with severe itching, and
it is caused due to contact with external irritants such as nettle, physical
agents, foods, insects bites, serum sickness, pollens, drugs, milk, egg, meat
etc.6
In classical texts they have mentioned
number of treatments for Sheetapitta like Abhyanga, Swedana,Vamana, Virechana
and Raktamokshana, among them Virechana
subsides theVititatedVata ,Pitta, Kapha
by eliminating doshas through anal route and does the Raktashodhana
and KostaShuddi. In Siravyadha it does
RaktaShodhna by removing DushitaRakta by vein puncture .7 8
The present study intends
to evaluate the comparative effect of Virechana and Siravyadha in the
Management of Sheetapitta. |