| CTRI Number |
CTRI/2018/03/012828 [Registered on: 26/03/2018] Trial Registered Prospectively |
| Last Modified On: |
23/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Internal oleation therapy in a modified method- precursor for the detoxification therapy with Panchakarma in Ayurvedic treatment |
|
Scientific Title of Study
|
An observational clinical study on modified method of Shodhanartha Snehapana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rijuta Patil |
| Designation |
PG Scholar |
| Affiliation |
J S Ayurved Mahavidhyalaya |
| Address |
J S Ayurved Mahavidhyalaya, College Road Nadiad, Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
7507727209 |
| Fax |
|
| Email |
patilrijuta@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Padmakumar Joshi |
| Designation |
Professor |
| Affiliation |
J S Ayurved Mahavidhyalaya |
| Address |
J S Ayurved Mahavidhyalaya, College Road Nadiad, Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
9825426885 |
| Fax |
|
| Email |
nayanjoshi_2005@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rijuta Patil |
| Designation |
PG Scholar |
| Affiliation |
J S Ayurved Mahavidhyalaya |
| Address |
J S Ayurved Mahavidhyalaya, College Road Nadiad, Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
7507727209 |
| Fax |
|
| Email |
patilrijuta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| J. S. Ayurved Mahavidhylaya, College Road, Nadiad Gujrat |
|
|
Primary Sponsor
|
| Name |
J S Ayurved Mahavidhylaya Nadiad Gujrat |
| Address |
J. S. Ayurved Mahavidhylaya, College Road Nadiad Gujrat |
| 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 Rijuta Patil |
J S Ayurved Mahavidhyalaya |
College Road Nadiad Gujrat 387001
Kheda
GUJARAT |
7507727209
patilrijuta@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients who are applicable for Vamana and Virechana, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients those are suggested for snehapana as purv a karma of Vamana or Virechana |
|
| ExclusionCriteria |
| Details |
Patients who are not eligible for Snehapana |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Administration of Shodhanartha Sneha twice a day produces Samyak yoga Lakshana of Snehapana |
Administration of Shodhanartha Sneha twice a day produces Samyak yoga Lakshana of Snehapana |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not Applicable |
|
|
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)
|
26/03/2018 |
| 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
|
Not Applicable. This thesis work is yet to be completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The main Shodhana procedures of Panchakarma includes Vamana, Virecana and Niruha Basti. All these procedures are performed in three stages i.e. PÅ«rvakarma, PradhÄnakarma and PaÅ›chÄtkarma. PÅ«rvakarma of Vamana and Virecana includes mainly Snehapana and Svedana. Amongst these two, Snehapana is time consuming and it requires more precise observation. The outcome of Vamana and Virecana depends on proper Snehapana because it prepares body for easy elimination of vitiated Dosas by action of Vamana and Virecana drugs. This study is aimed to observe modified method of Shodhanartha Snehapana in P D Patel Ayurved Hospital Nadiad. Samyaka Yoga, Ayoga and Atiyoga Lakshanas of Snehapana as well as complications if any will be observed. The outcome of the Vamana and Virecana which are to be performed after Snahapana will also be observed.
|