| CTRI Number |
CTRI/2025/02/080540 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
OBSERVATIONAL OF HAEMATOLOGICAL CHANGES IN VICHARCHIKA (SKIN CONDITION)
|
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY TO COMPARE THE HAEMATOLOGICAL
INVESTIGATIONS BETWEEN SRAVI AND ASRAVI VICHARCHIKA
|
| 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 VAISHNAVI V BANDRAD |
| Designation |
PG SCHOLAR |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 573201 KARNATAKA |
| Address |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 573201 KARNATAKA
DEPARTMENT OF ROGANIDANA EVAM VIKRITI VIJNANA
II YEAR PG SCHOLAR
Hassan
KARNATAKA
573201
India |
| Phone |
8951272539 |
| Fax |
|
| Email |
pg23142@sdmcahhassan.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NANDESH MOHAN P |
| Designation |
Associate Professor |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 573201 KARNATAKA |
| Address |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 573201 KARNATAKA
DEPARTMENT OF ROGANIDANA EVAM VIKRITI VIJNANA
Hassan
KARNATAKA
573201
India |
| Phone |
7204442020 |
| Fax |
|
| Email |
drsrinanden@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NANDESH MOHAN P |
| Designation |
Associate Professor |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 573201 KARNATAKA |
| Address |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 573201 KARNATAKA
DEPARTMENT OF ROGANIDANA EVAM VIKRITI VIJNANA
Hassan
KARNATAKA
573201
India |
| Phone |
7204442020 |
| Fax |
|
| Email |
drsrinanden@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD AND IPD PATIENTS OF SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 573201 KARNATAKA |
|
|
Primary Sponsor
|
| Name |
DR VAISHNAVI V BANDRAD |
| Address |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 573201 KARNATAKA |
| 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 VAISHNAVI V BANDRAD |
SRI DHARMSTAHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 573201 KARNATAKA |
DIAGNOSTIC BLOCK
DEPARTMENT OF ROGANIDANA EVAM VIKRITI VIJNANA
Hassan
KARNATAKA |
8951272539
pg23142@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 573201 KARNATAKA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fulfilling diagnostic criteria.
Subjects who are willing to participate and sign the informed consent.
Subjects between age group of 16-70 years of either gender, irrespective of occupation, race
and socio-economic status |
|
| ExclusionCriteria |
| Details |
Patients with diagnosed skin diseases other than Vicharchika.
Pregnant and Lactating women.
Patients diagnosed with allergic and inflammatory diseases of other systems which may
interfere with the study. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
There will be Two groups A and B.Group A contains subjects having Sravi Vicharchika and Group B contains subjects having Asravi Vicharchika with minimum of 20 subjects in each group.
All the subjects will be subjected to Haematological Investigations (TLC, DLC, ESR, ACE). Changes in the parameters will be
observed, recorded, analysed by comparing with normal range. |
CROSS SECTIONAL STUDY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the variations of Total Leucocyte Count in Sravi & Asravi Vicharchika.
To observe the variations of Differential Leucocyte Count in Sravi & Asravi Vicharchika.
To observe the variations of Absolute Eosinophil count in Sravi & Asravi Vicharchika.
To observe the variations of Erythrocyte sedimentation rate in Sravi & Asravi Vicharchika. |
CROSSECTIONAL STUDY |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/02/2025 |
| 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)
|
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
|
In Ayurveda all the skin diseases are included under the Kushta roga further classified in two divisions
i.e. Mahakushta and Kshudrakushta1
. Vicharchika is a type of kshudra kushta. It is a Rakta Pradoshaja
Vikara characterized with symptoms namely kandu, rukshata, ruja and pitta predominant according to
sushruta2 and kandu, srava, pidika and kapha predominant according to charaka3
. This is caused due
to Viruddha Aahara, excess Drava, Snigdha, Guru Aahara, Chardi Vegadharana, Nava Anna, Dadhi,
Matsya Atisevana, Divaswapna etc4
. It runs a chronic course and has a tendency of exacerbation.
Most of the skin diseases are present with acute or chronic inflammation as a part of the
pathogenesis. Studies suggest that TLC, DLC, ESR, AEC tests can be used as a screening tool for
specific infections. TLC, DLC, ESR are blood tests useful in detecting inflammation and infections in
the body. An AEC is a blood test that measures the number of White blood cells called Eosinophils.
During an allergic reaction, Eosinophils are increased.
Disease is the outcome of imbalanced state of Dosha which manifest through different clinical
and biochemical changes. Therefore, it’s clear that the progress of aggravation of Dosha took place
from the beginning of the disease and perhaps Rakta is the best media where biological changes are
reflected. Hence TLC, DLC, ESR, AEC tests can support to know about the cause, differential diagnosis
and prognosis of the disease Vicharchika. Hence there is a need to evaluate the variations of TLC, DLC,
ESR, AEC tests in Vicharchika, and by knowing the variations in these parameters among Sravi and
Asravi Vicharchika helps in its treatment and prognosis. |