| CTRI Number |
CTRI/2015/07/006031 [Registered on: 20/07/2015] Trial Registered Retrospectively |
| Last Modified On: |
20/07/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Survey study |
| Study Design |
Other |
|
Public Title of Study
|
A Survey study to establish relation between Deha prakriti(Bodely constitution) and Vyadhikshamatva(immunity). |
|
Scientific Title of Study
|
The concept of Deha prakriti and its impact on Vyadhikshamatva |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devangkumar A Patel |
| Designation |
MD scholar |
| Affiliation |
IPGT RA JAMANAGAR |
| Address |
Bhardwaj bhavan PG boys hostel room no 22 department IPGT and RA GAU
Jamnagar
OPD No 18 Basic Principles department IPGT and RA GAU
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9904670602 |
| Fax |
|
| Email |
dr.devpatel89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrASBaghel |
| Designation |
Associate Professer |
| Affiliation |
IPGT RA JAMANAGAR |
| Address |
OPD No 18 Basic Principles department IPGT and RA GAU
Jamnagar
GUJARAT
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9426433575 |
| Fax |
|
| Email |
asbaghel2001@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof RR Dwivedi |
| Designation |
Professor and Head Basic Principles department |
| Affiliation |
IPGT RA JAMANAGAR |
| Address |
OPD No 18 Basic Principles department IPGT and RA GAU
Jamnagar
GUJARAT
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9426206906 |
| Fax |
|
| Email |
dwivedirb53@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| IPGT and RA GAU
Jamnagar
GUJARAT
361008
India
|
|
|
Primary Sponsor
|
| Name |
IPGT and RA GAU Jamnagar |
| Address |
IPGT and RA GAU
Jamnagar
GUJARAT
361008
India
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Devangkumar Arvindbhai Patel |
Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar |
OPD no.18, Department
of Basic Principles,
Institute for Post
Graduate Teaching and
Research in Ayurveda,
Gujarat Ayurved
University, Jamnagar –
361008
Jamnagar
GUJARAT |
9904670602
dr.devpatel89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC IPGT AND RA JAMNAGAR |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
COMMON COLD,FEVER,COUGH,STOMATITIS.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A
Group B |
Group A- It will include healthy volunteers for evaluation of Deha prakriti and to know the history of illness in them of past 5 years without any bar of caste, religion, occupation and sex
Inclusion criteria-(group A)
 Healthy volunteers
 Age- 20-40 years
Group-B- It will include the person who are frequently become victim of some specific disease like common cold, cough, fever, stomatits etc without any bar of caste, religion, occupation & sex.
Inclusion criteria-(group B)
 Persons who became frequently victim of some specific disease like common cold, cough, fever, stomatits etc
 Age-20-40 years
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria-(group A)
 Healthy volunteers
 Age- 20-40 years
Inclusion criteria-(group B)
 Persons who became frequently victim of some specific disease like common cold, cough, fever, stomatits etc
 Age-20-40 years
|
|
| ExclusionCriteria |
| Details |
1) Exclusion Criteria
i. Patients suffering from chronic major illness like Tuberculosis, DM, cancer etc.
ii. Age: <20 and >40 years
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vyadhikshamatva is found to be good in Kapha Prakriti people |
after taking history of last five years Vyadhikshamatva is found to be good in Kapha Prakriti people |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| impact of deha prakriti on Vyadhi Kshamatva |
life long |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/04/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
no publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a survey intended to search out the impact and interrelationship between Deha prakriti and Vyadhikshamatva (Vyadhibalavirodhitva and Vyadhiutpadakpratibandhaktva).This study will be divided in two groups.Group A includes Healthy volunteers and Group B includes the
persons who are frequently become victim of some specific disease like common cold, cough,
fever, stomatits etc to search out the
Relation between Deha prakritis and Vyadhikshamtva by scoring and gradation pattern. Data analysis and other tools of statistics will be applied.Routine investigation of blood, urine and stool will be carried out in all the survey individuals to rule out any other pathology before including a study ,randomly 10 individual of pravar, madhya and alpa vydhikshamatva will be assessed for Immunoglobulin level like IgG, IgM. |