| CTRI Number |
CTRI/2018/03/012722 [Registered on: 21/03/2018] Trial Registered Prospectively |
| Last Modified On: |
06/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A STUDY TO ASSESS THE EFFECT OF UNCTOUS QUALITY OF GHEE IN VATA PRADHANA PRAKRITI WITH RESPECTIVE TO DRYNESS |
|
Scientific Title of Study
|
A STUDY TO ASSESS THE EFFECT OF SNIGDHA GUNA OF GHRITA IN VATA PRADHANA PRAKRITI WITH RESPECTIVE TO RUKSHA GUNA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
s v dinass kumar |
| Designation |
Pg scholar |
| Affiliation |
parul instititue of ayurved |
| Address |
Swastha vritta OPD room no 115,parul institute of ayurved parul university
limda,wagodia,vadodara dist,gujarat
Swastha vritta OPD room no 115,parul institute of ayurved parul university
limda,wagodia,vadodara dist,gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9566008221 |
| Fax |
02668260201 |
| Email |
dinash10bams@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr vaidehi roale |
| Designation |
professor |
| Affiliation |
parul instititue of ayurved |
| Address |
parul institute of ayurved parul university
limda,wagodia,vadodara dist,gujarat
parul institute of ayurved parul university
limda,wagodia,vadodara dist,gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9824284371 |
| Fax |
02668260201 |
| Email |
vraole3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
s v dinass kumar |
| Designation |
Pg scholar |
| Affiliation |
parul instititue of ayurved |
| Address |
Swasth vritta OPD no 115 parul institute of ayurved parul university
limda,wagodia,vadodara dist,gujarat
Swasth vritta OPD no 115 parul institute of ayurved parul university
limda,wagodia,vadodara dist,gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9566008221 |
| Fax |
02668260201 |
| Email |
dinash10bams@gmail.com |
|
|
Source of Monetary or Material Support
|
| parul institute of ayurved
parul university
limda waghodia vadodara gujarat |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [self sponsorship] |
|
|
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 |
| s v dinass kumar |
parul instittue of ayurved |
Swastha vritta OPD no 115 parul institute of ayurved
parul university
limda waghodia vadodara dist gujart
Vadodara
GUJARAT |
9566008221
0266260201
dinash10bams@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIA-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
unctous nature on dryness nature(on palm sole dryness and constipiation) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Go-ghrita |
Dosage:1 teaspoon
Anupan:1 glass of skimmed milk.
Time of administration:at night before bed.
Duration:1 month.
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1)People with age group of 18-30yrs
2)Vata pradahana person having with these symptoms are selected
|
|
| ExclusionCriteria |
| Details |
1)People below age group of 18 and above age group of 35.
2)Pitta and kapha pradhana prakriti and other systemic and other disorders are excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Dryness will be assessed by dryness grading scale
|
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 3. Constipation grading scale will be given for assessing the constipation |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/04/2018 |
| Date of Study Completion (India) |
10/01/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/01/2019 |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. Methods of collection of data- Person with vata pradahana prakrti is assessed and their ruksha guna is assessed with pada hasta parushatwa and malabandhatva and then adviced to take 1 tsp of gritha with kshira as anupana for the duration of one month then the dryness of hasta pada parshutwat and mala bandatwat are evaluated. Every 15 days will be assessed,after 1 month effect of ghrita will be assessed |