| CTRI Number |
CTRI/2020/06/025770 [Registered on: 10/06/2020] Trial Registered Prospectively |
| Last Modified On: |
31/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find relation between Viruddhahar and Dadru kushtha(Tinea). |
|
Scientific Title of Study
|
An Observational Study To find co relation between Viruddhahar and Dadru kushtha In Fisherman of coastal region. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Viraj Shekhar Athalye |
| Designation |
PG Student |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi
Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality
Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
8007525118 |
| Fax |
|
| Email |
viraj.athalye@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tushar Khairnar |
| Designation |
Professor |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi
Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality
Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9561587055 |
| Fax |
|
| Email |
dr.tushar.khairnar2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Viraj Shekhar Athalye |
| Designation |
PG Student |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi
Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality
Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
8007525118 |
| Fax |
|
| Email |
viraj.athalye@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research center, Agadtantra Department, Nigdi,
Pradhikaran, Sector 25, pune 44 |
|
|
Primary Sponsor
|
| Name |
Principal PDEAs College of Ayurved and Research center |
| Address |
PDEAs College of Ayurved and Research center, Nigdi, Pradhikaran,
Sector 25, pune 44 |
| Type of Sponsor |
Private medical college |
|
|
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 Viraj Athalye |
Local District Hospital Ratnagiri |
Jai sthamb road, Near Ratnagiri nagarparishad, Ratnagiri 415612
MAHARASHTRA
Ratnagiri
MAHARASHTRA |
8007525118
viraj.athalye@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B359||Dermatophytosis, unspecified, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients involved in fishing occupation since last one year
2. Age group- 20 to 60 years.
3. Patients with the history of viruddhaaharsevan and matsya.
4. Patients with sign and symptoms of Dadru
|
|
| ExclusionCriteria |
| Details |
1. Any type of secondary infection of skin.
2. Any person who shows signs and symptoms other than dadru kushtha
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find correlation between viruddhaahar and Dadru Kushtha in Fisherman |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is no corelation between viruddhaahar and Dadru Kushtha in Fisherman |
12 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In Ayurveda Viruddhaahar further causes imbalance of dhatu in the body and mostly Raktdhatu (vital tissue)dushti is caused.due to dhatudhushti it causes many skin disease like Kushtha(skin disease),koth(blister),Dadru,(dermatophytosis),vicharchika(eczema) and further more.Kushtha is then classified in mainly two types Kshudrakushtha and Mahakushtha.Viruddhahar is mainly the important hetu(cause) for the Kushtha.Viruddhaharsevan in excess acts like dushivisha and garvisha in the body.Thus it has many adverse effects on the health and causes many diseases in the body.
ViruddhAaharis considered as major hetu which leads to dushivisha or garvisha which are main factors causing Dadru Kushtha.Recently more number of patient are affected by Dadru kushtha which has severe impact on patients. Also in samhitas it is mention that people having Dadru kushtha should be treated effectively and should not be neglected.Fisherman are more prone to Dadru kushtha as Viruddhahar sevan and fish consumption is more in them and in samhitas it is clearly mentioned that Viruddhahar and fish frequently in the diet is one of the hetus of kushtha. So acharyacharak has explained Viruddhahar in Sutrasthan chapter 26 in detail because it is having major health impact on the body and many diseases are lineked due to its consumption,specially skin diseases.in these 18 types acharyaCharak has explained in detail how the viruddhahar has its effects and its types like Gun viruddha,VidhiViruddha,Sanskarviruddha,deshviruddha,kalviruddha etc.
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