| CTRI Number |
CTRI/2020/12/030043 [Registered on: 28/12/2020] Trial Registered Prospectively |
| Last Modified On: |
27/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on modified method of purificatory medicated ghrita for purification of the body. |
|
Scientific Title of Study
|
AN OBSERVATIONAL CLINICAL STUDY ON MODIFIED METHOD OF SHODHANARTHA SNEHAPANA - A CONTINUOUS STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DHARMISHTHA GAROD |
| Designation |
PG SCHOLAR |
| Affiliation |
J S AYURVEDA MAHAVIDYALAYA |
| Address |
PANCHKARMA DEPARTMENT, P D PATEL AYURVED HOSPITAL,J S AYURVEDA MAHAVIDYALAYA,COLLEGE ROAD,NADIAD
PANCHKARMA DEPARTMENT, P D PATEL AYURVED HOSPITAL,J S AYURVEDA MAHAVIDYALAYA,COLLEGE ROAD,NADIAD
Kheda
GUJARAT
382415
India |
| Phone |
7984231028 |
| Fax |
|
| Email |
dkbhuriya512@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF Dr KALAPI B PATEL |
| Designation |
PROFESSOR |
| Affiliation |
J S AYURVEDA MAHAVIDYALAYA |
| Address |
PANCHKARMA DEPARTMENT, P D PATEL AYURVED HOSPITAL,J S AYURVEDA MAHAVIDYALAYA,COLLEGE ROAD,NADIAD
PANCHKARMA DEPARTMENT, P D PATEL AYURVED HOSPITAL,J S AYURVEDA MAHAVIDYALAYA,COLLEGE ROAD,NADIAD
Kheda
GUJARAT
387001
India |
| Phone |
9428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DHARMISHTHA GAROD |
| Designation |
PG SCHOLAR |
| Affiliation |
J S AYURVEDA MAHAVIDYALAYA |
| Address |
PANCHKARMA DEPARTMENT, P D PATEL AYURVED HOSPITAL,J S AYURVEDA MAHAVIDYALAYA,COLLEGE ROAD,NADIAD
PANCHKARMA DEPARTMENT, P D PATEL AYURVED HOSPITAL,J S AYURVEDA MAHAVIDYALAYA,COLLEGE ROAD,NADIAD
Kheda
GUJARAT
382415
India |
| Phone |
7984231028 |
| Fax |
|
| Email |
dkbhuriya512@gmail.com |
|
|
Source of Monetary or Material Support
|
| • Sundar Ayurveda Teaching Pharmacy, Post Graduate Departmentof Rasashastra & Bhaiṣajya Kalpana, J S Ayurveda Mahavidyalaya, Nadiad. |
|
|
Primary Sponsor
|
| Name |
J S AYURVEDA MAHAVIDYALAYA |
| Address |
COLLEGE ROAD,NADIAD |
| 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 DHARMISHTHA GAROD |
P D Patel Ayurveda Hospital |
PG Department Panchkarma devision P D Patel Ayurveda hospital J S Ayurveda college campus college Road
Nadiad-387001
Kheda
GUJARAT |
7984231028
dkbhuriya512@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
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 Purvakarma of Vamana or Virechana.
Patients having age between 18 to 60 years. |
|
| ExclusionCriteria |
| Details |
Patients who are Ayogya (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 does not produce Samyak Yoga Lakshanas of Snehana |
Before snehapana and after vamana or virechana karma. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Administration of Shodhanartha Sneha twice a day does produce Samyak Yoga Lakshanas of Snehana before 7 days. |
Before snehapana and after snehapan we can do lipid profile of all patient. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2020 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
THIS WILL BE SUBMITTED IN A FORM OF DISSERTATION AND MAY PIBLISHED IN ANY PEER REVIEW JOURNAL WITH PRIOR PERMISSION OF GUJARAT AYURVEDA UNIVERSITY. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is aimed to evaluate the Samyak Snigdha Lakshana, and Samyak yoga of Vamana and Virechana of patients undergoing Shodhanartha Snehapana. Total 200 patients registered from IPD of Kayachikitsa and panchkarma of P D Patel Ayurveda Hospital. In this study, the Sneha has been given to the patients in divided doses (in morning and evening). The Jiryamana Lakshana, Jirna Lakshana and Samyak Sigdha lakshana of Snehpana had been observed throughout the course of treatment and it supports the alternate hypothesis that modified method of Snehpana is useful to achieve Samyak Snigdha Lakshana. It is also observed that Samyak Yoga Lakshana of Vamana and Virechana had also been achieved by most of the patients significantly. Results: Looking to all
these facts, it can be concluded that the modified method of Shodhanartha Sneha
is useful and convenient for the patients. It can also be concluded that Samyak
Snigsha Lakshanas can be achieved earlier and 2-3 important days of the
patients can be saved by use of modified method of Shodhanartha Snehapana. |