| CTRI Number |
CTRI/2025/04/084168 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study Of Urine In Vicharchika Patient By Taila Bindu Pareeksha |
|
Scientific Title of Study
|
A Cross Sectional Study Of Urine In Vicharchika With Special Reference To Taila Bindu Pareeksha |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Sharma |
| Designation |
PG Scholar |
| Affiliation |
National institute of ayurveda Jaipur |
| Address |
National institute of Ayurveda
jorawar singh gate amer road Jaipur 302002 Rajasthan
Jaipur RAJASTHAN 302002 India |
| Phone |
8209731387 |
| Fax |
|
| Email |
sharmaaankita0798@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mahendra Prasad |
| Designation |
Associate professor |
| Affiliation |
National institute of ayurveda Jaipur |
| Address |
National Institute of Ayurveda
kriya Sharir Department Jaipur 302002 Rajasthan
Jaipur RAJASTHAN 302002 India |
| Phone |
9887315717 |
| Fax |
|
| Email |
mprasadmahendra5@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bhanu Pratap Singh |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
National Institute of Ayurveda Kriya Sharir Department Jaipur
302002 Rajasthan
Jaipur RAJASTHAN 302002 India |
| Phone |
8562816969 |
| Fax |
|
| Email |
bhanushekhawat17@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jorawar Singh Gate Amer road Jaipur Rajasthan 302002 India |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Jorawar Singh Gate Amer Road Jaipur 302002 Rajasthan 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 Ankita Sharma |
National Institute of Ayurveda |
Urology lab kriya sharir department National institute of Ayurveda Jaipur
Jaipur Jaipur RAJASTHAN |
8209731387
sharmaaankita0798@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITEE NATIONAL INSTITUTE OF AYURVEDAE |
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: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with the classical features of Vicharchika with symptoms Kandu, Vaivarnya . |
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating mother and Known case of Kidney disease Diabetes Carcinoma or any other systemic disease
Patients under any medication except Vicharchika |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the spreading shape and direction of spreading of Taila Bindu in urine of patients with Vicharchika. |
78 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in composition of urine in Vicharchika.
|
72 Weeks |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
09/05/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
All skin disorders
are coming under the topic of Kustha
Roga in Ayurveda The two forms of Kustha Roga mentioned in
classical texts they are Mahakushta and Kshudrakustha which are further divided into seven and eleven varieties respectively Kustha
is categorised in a Astha Mahagada According to Ayurveda Vicharchika is Rakta Pradoshaja Vikara Being affected by three Dosha Vicharchika is a kapha dominating Vikara Modern science says that Vicharchika presents clinically as Eczema Eczema is a
type of dermatitis in which skin becomes
inflamed. Atopic dermatitis, which is characterized by dry skin that itches and
has poorly defined patches of scale and erythema.
Under the broad heading of Asthavidha Pareeksha,
Acharya Yogratnakar described Mutra Pareeksha which is used to knowing
the prognosis of disease from Samhita kala In this context various
characteristic features of Mutra (urine) vitiated by Tridosha has
been described They also stated that in different diseased conditions features of urine were also vary according to status of Dosha. The
precautions to be taken during urine examination have also been appropriately
described here Characteristic features of Sama and Nirama Mutra Sadhya and Asadhyarogi Jeerna and Ajeerna condition of Mutra has
also been describedTaila Bindu
Pareeksha a method of urine examination has been described in number of Ayurvedic texts
medieval period like Vasavarajiyam Yogaratnakar and Vangasena Samhita
NEED OF STUDY
Vicharchika can be
correlated with eczema in modern science. Prevalence of Eczema in adult could
be as high as 10.7% overall and as high as 18.1% in individual states and 21%
across various country Atopic eczema affects 15-20% of children and 1-3% of
adults worldwide
In Vicharchika
description and specific characteristics of Mutra are not mentioned in
classics but there may be some relation between characteristics of Mutra and
Vicharchika
RESEARCH GAP ANALYSIS
No studies have been
done on the characteristic feature of urine in Vicharchika also this
study helps to know about the relevance of Taila Bindu Pareeksha in Vicharchika
RESEARCH QUESTION
Is there any association
of movement of Taila Bindu dropped in urine sample of Vicharchika patient
with respect to shape and direction of spreading?
STATMENT OF HYPOTHESIS
NULL HYPOTHESIS (H0)
There is no Association
in shape and direction of spreading of Taila Bindu dropped in urine of Vicharchika
ALTERNATIVE HYPOTHESIS (H1)
There is association
in shape and direction of spreading of Taila Bindu dropped in urine of Vicharchika
AIM
To study the
urine in Vicharchika with special reference to Taila Bindu Pareeksha
OBJECTIVES
Primary objective
To
study the movement of Taila Bindu in urine by its shape and direction of
spreading in Vicharchika
Secondary
objective
To study the Physical, biochemical
and microscopic examination of urine in Vicharchika
OUTCOMES
PRIMARY OUTCOME
Changes in the spreading shape and
direction of spreading of Taila Bindu in urine of patients with Vicharchika.
SECONDARY OUTCOME
Change in composition of
urine in Vicharchika
|