| CTRI Number |
CTRI/2016/02/006669 [Registered on: 22/02/2016] Trial Registered Prospectively |
| Last Modified On: |
20/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
CO-RELATION OF BODY CONSTITUTION AND LIFE STYLE WITH KHALITYA |
|
Scientific Title of Study
|
A SURVEY STUDY ON INTER-RELATIONSHIP OF DEHAPRAKRITI AND LIFE STYLE WITH KHALITYA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sujata Dhoke |
| Designation |
Phd Scholar |
| Affiliation |
IPGT AND RA GAU JAMNAGAR |
| Address |
Department
of Basic principles Institute for Post Graduate Teaching and
Research in Ayurveda GAU Jamnagar Gujarat 361008
Room no 123 PG Girls Hostel Institute for Post Graduate Teaching and
Research in Ayurveda GAU Jamnagar Gujarat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9824744048 |
| Fax |
|
| Email |
sujubasic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Mahesh K Vyas |
| Designation |
Professor and HOD |
| Affiliation |
IPGT AND RA GAU JAMNAGAR |
| Address |
ROOM NO 303 FLOOR 3 NEW BUILDING INSTITUTE FOR POSTGRADUATE TEACHING AND RESEARCH IN AYURVEDA GAU JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9426953118 |
| Fax |
|
| Email |
drmaheshvyas@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Hitesh Vyas |
| Designation |
Associate Professor |
| Affiliation |
IPGT AND RA GAU JAMNAGAR |
| Address |
ROOM NO 304 FLOOR 3 NEW BUILDING INSTITUTE FOR POSTGRADUATE TEACHING AND RESEARCH IN AYURVEDA GAU JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9426433231 |
| Fax |
|
| Email |
drhavyas@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IPGT AND RA GAU JAMNAGAR |
| Address |
OPD No 18 Basic Principles department IPGT and RA GAU
Jammagar |
| 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 sujata dhoke |
Department of Basic Principles |
OPD no.18 Department
of Basic Principles
Institute for Post
Graduate Teaching and
Research in Ayurveda
Gujarat Ayurved
University Jamnagar –
361008
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
9824744048
sujubasic@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Institute for Post Graduate Teaching and Research in Ayurved GAU Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L638||Other alopecia areata, patients suffering from hairfall,scalp itching,dryness of hair will be selected, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients having age between 16 to 55 years.
Patients having symptoms of Khalitya i.e Keshapatan / Darunaka / Kesha-Rukshata etc. have been selected irrespective of any bar of caste, gender, religion and occupation.
|
|
| ExclusionCriteria |
| Details |
Patients whose age was less than 12 and above 55 years.
Patients who have been diagnosed to have local disease like Alopecia areata, Alopecia totalis, Tinea capitalis, Folliculitis decalvans and in Ayurvedic terms patients of Arunshinka, Indralupta.
Patient suffering from any severe systemic disease was excluded like hypothyroidism etc.
Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| it will be benificial to find out the cause of hairfall in different constitutions of persons. |
it will be benificial to find out the cause of hairfall in different constitutions of persons. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| life style modification will be advised in different constitution of persons and it will also beneficial to treat the patients of hairfall |
life style modification will be advised in different constitution of persons and it will also beneficial to treat the patients of hairfall |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="500" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2016 |
| Date of Study Completion (India) |
08/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a cross sectional survey study which is planned for assessment of Dehaprakriti and Life style in patients of Khalitya
( hairfall) with a view to scientifically document the cause and effect
relationship of disease that will be use
in future for the management of Khalitya.
|