CTRI Number |
CTRI/2021/09/036195 [Registered on: 03/09/2021] Trial Registered Prospectively |
Last Modified On: |
01/09/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Saindhavadi lepa and sindhooradi lepaapplication for the managment of vipadika. |
Scientific Title of Study
|
“A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF SAINDHVAADI LEPA IN THE MANAGEMENT OF VIPADIKA’’. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrAkshata Sangolli |
Designation |
P.G. Scholar |
Affiliation |
sri sri college of ayurvedic science and research. |
Address |
room no.r 8 Department of Panchakarma Sri Sri College of Ayurvedic Science and Research Hospital, 21 km udipalya post Bangaluru. room no.r 8 Department of Panchakarma Sri Sri College of Ayurvedic Science and Research Hospital, 21 km udipalya post Bangaluru. Bangalore KARNATAKA 560082 India |
Phone |
9480534762 |
Fax |
|
Email |
akshataaksha363@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ganesh Puttur |
Designation |
HOD and Principal |
Affiliation |
sri sri college of ayurvedic science and research. |
Address |
room no.r 8,department of Panchakarma.Sri Sri College of Ayurvedic Science and Research hospital Bangalore.21 km udipalya post. room no.r 8,department of Panchakarma.Sri Sri College of Ayurvedic Science and Research hospital Bangalore.21 km udipalya post Bangalore KARNATAKA 560082 India |
Phone |
9448176059 |
Fax |
|
Email |
drganeshputtur@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ganesh Puttur |
Designation |
Principal and HOD department of Panchakarma |
Affiliation |
sri sri college of ayurvedic science and research. |
Address |
room no.r 8 Department of Panchakarma Sri Sri College of Ayurvedic Science and Research Hospital, 21 km udipalya post Bangaluru. room no.r 8 Department of Panchakarma Sri Sri College of Ayurvedic Science and Research Hospital, 21 km udipalya post Bangaluru. Bangalore KARNATAKA 560082 India |
Phone |
9448176059 |
Fax |
|
Email |
drganeshputtur@gmail.com |
|
Source of Monetary or Material Support
|
room no.r 8 Department of Panchakarma Sri Sri College of Ayurvedic Science and Research Hospital, 21 km udipalya post Bangaluru. |
|
Primary Sponsor
|
Name |
Akshata sangolli |
Address |
Sri Sri College of Ayurvedic Science and Research Hospital Bangalore. |
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 Akshata Sangolli |
SRI SRI COLLEGE OF AYURVEDCIS SCIENCE AND RESEARCH HOSPITAL, BENGALURU |
Room no. 08, Panchakarma OPD. Bangalore KARNATAKA |
9731018686
akshataaksha363@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: VIPADIKA, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Saindhavadi Lepa |
After cleaning the affected area with hot water, apply the Saindhavadi Lepa and leave it for 6 hours, wash it in the morning with hot water |
Comparator Agent |
Sindhooradi Lepa |
After cleaning the affected area with hot water, apply the Sindhooradi Lepa and leave it for 6 hours, wash it in the morning with hot water |
|
Inclusion Criteria
|
Age From |
21.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Subjects aged between 21 - 65 years, irrespective of gender, caste, occupation,
socio-economic status.
Subjects with complaints of cracked foot and palm.
Subjects willing to give written consent. |
|
ExclusionCriteria |
Details |
Pregnant and lactating women.
Subjects having systemic diseases like Diabetic foot, Plantar psoriasis, Cellulitis,
Eczema, Contact dermatitis and other skin diseases.
Subjects with excessive hardening of the margins of palms and foot. |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
reduction in number of cracks of foot and reduction of pain in the foot. |
0th,10th and 20th day. |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
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
|
N/A |
Date of First Enrollment (India)
|
11/09/2021 |
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="2" Months="0" 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
|
Skin is a dress
that one wears for lifetime which plays very important role from protection to
cosmetic. As it comes first in contact with environment it is the first barrier
of protection from physical, chemical and biological agents. Therefore,
diseases of this organ become great deal of misery, mainly because it is
visible.
In Ayurveda all
the diseases of skin are dealt under the heading of kushta, in other words it
can be known as “Ayurvedic dermatology. Kushta are mainly divided
into two groups i.e. Maha kushta and Kshudra kushta. Among the number of
kushta, Vipadika falls under kshudra kushta. It is characterized by sphutana
either in palms or soles or in both with teevra vedana. It is most
commonly found issue in the present world as the incidence rate is found to be
58.4%. When the condition of Vipadika is neglected it affects the
living condition of one’s life as it becomes portal entry for the organisms and
can cause many inflammatory diseases like lymphangitis, eczema, cellulitis etc.
By looking at
the symptoms, this disease can be co-related with palmoplantar psoriasis,
palmoplantar keratoderma, palmoplantar xerosis,
palmoplantar dermatophyte, fissures of heel and palm, eczema of
hands and foot.
In the
contemporary science, the treatment of cracked foot is Keratolytic (salicylic
acid), paraffin, petroleum gel etc.These above-mentioned
medications give temporary relief and fail to minimize the recurrence. Hence,
the need for formulations which gives quick, prolonged and better result is
required.
Since every
sector in this globalized world has a busy lifestyle, therefore treatment
aspects should be convenient considering the busy lifestyle. Lepa is one such
convenient method of treatment. As we all know snehana is the best mode of
treatment for vata and Vipadika is one among vataja nanatmaja vyadi. Hence lepa which has snehana properties is selected, by keeping it in mind and
by looking into the ingredients of saindhavadi lepa as it contains many of the
sneha dravyas like taila, sarpi, etc.an effort is made to evaluate its efficacy
in the management of Vipadika in the present study. |