| CTRI Number |
CTRI/2019/12/022324 [Registered on: 11/12/2019] Trial Registered Prospectively |
| Last Modified On: |
14/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Between Vatsaka Beeja Churna and Madanaphala Pippali Churna in Vamana Karma |
|
Scientific Title of Study
|
A COMPARATIVE STUDY TO EVALUATE
THE EFFECTIVENESS OF VATSAKA BEEJA CHURNA AND
MADANPHALA PIPPALI CHURNA IN VAMANA KARMA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRATIME GULERIA |
| Designation |
PG SCHOLAR |
| Affiliation |
J S AYURVEDA MAHAVIDYALAYA |
| Address |
J S AYURVEDA MAHAVIDYALAYA
PANCHAKARMA DEPARTMENT
COLLEGE ROAD
NADIAD
Kheda
GUJARAT
387001
India |
| Phone |
8146136008 |
| Fax |
|
| Email |
drpratimaguleria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KALAPI B PATEL |
| Designation |
H.O.D PANCHAKARMA DEPARTMENT |
| Affiliation |
J S AYURVEDA MAHAVIDYALAYA |
| Address |
J S AYURVEDA MAHAVIDYALAYA
PANCHAKARMA DEPARTMENT
COLLEGE ROAD
NADIAD
Kheda
GUJARAT
387001
India |
| Phone |
9428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRATIME GULERIA |
| Designation |
PG SCHOLAR |
| Affiliation |
J S AYURVEDA MAHAVIDYALAYA |
| Address |
J S AYURVEDA MAHAVIDYALAYA
PANCHAKARMA DEPARTMENT
COLLEGE ROAD
NADIAD
Kheda
GUJARAT
387001
India |
| Phone |
8146136008 |
| Fax |
|
| Email |
drpratimaguleria@gmail.com |
|
|
Source of Monetary or Material Support
|
| SUNDAR AYURVEDA TEACHING PHARMACY OF J S AYURVEDA COLLEGE, NADIAD |
|
|
Primary Sponsor
|
| Name |
J S AYURVED 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 PRATIMA GULERIA |
P D Patel Ayurved Hospital |
J S AYURVEDA MAHAVIDYALAYA
PANCHAKARMA DEPARTMENT
COLLAGE ROAD
NADIAD
Kheda
GUJARAT |
8146136008
drpratimaguleria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Madanphala Pippali Churna group |
Madanphala Pippali Churna
Matra: 3-5 gms
Kala: Pratha Kala (Kaphaj Kala)
Anupana: Madhu
Root of administration: Oral |
| Intervention |
Vatsaka Churna group |
Vatsaka Churna
Matra:9-10gms
Kala: Pratha Kala (Kaphaj Kala)
Anupana: Madhu
Root of administration: Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are indicated for Vamana Karma.
2. Patient having normal ECG findings. |
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 18 and above 60 years of both gender will be included.
2. Persons who are contraindicated for Vamana Karma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| notify of Vamana Shuddhi in Patients |
Vamana Shudhi will be accessed on day of virechana according to vegas description given in classics. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/12/2019 |
| Date of Study Completion (India) |
10/04/2021 |
| 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 published in any peer reviewed journal with the prior permission of Gujarat Ayurveda University, Jamnagar. |
|
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 compare and evaluate the effectiveness of Vatsaka Beeja Churna and MadanphalaPippali Churna in Vamana Karma. A large number of formulations are described in Charaka Samhita but only Madanphala iswidely or commonly used. Vatsaka is also one of the six main Dravyas mentioned in Charaka Samhita for Vamana. The utility of Vatsaka for Vamana Karma is not elaborated much thereforethis study is planned to evaluate the effectiveness of Vatsaka Beeja Churna in comparison to Madanphala Pippali Churna in Vamana karma.Assessment of Vamana Karma was done on the basis of Vaigiki, Maniki, Antiki and Laingiki Shuddhi. The
analysis of the parameters for Samyak
Yoga of Vamana Karma including Antiki
Shuddhi, Laingiki Shuddhi and Vaigiki Shuddhi showed statistically
significant difference between the patients of group A where Madanaphalapippali Churna was given and
group B where Vatsakbeej Churna was
given to perform Vamana Karma. However,
no significant difference was observed between patients of both the group in Maniki Shuddhi.Looking
to these facts, it can be concluded that Madanaphalapippali Churna is more effective in
comparison to Vatsakabeeja Churna to perform Vamana Karma.
No any unwanted effect of the medicaments was
found in any of the patients included in this study.
|