| CTRI Number |
CTRI/2023/12/060905 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
25/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study of madanphaladi yoga and madanphala phanta yoga in vamana karma |
|
Scientific Title of Study
|
A Comparative Clinical Study of Madanphaladi Yoga and Madanphala Phanta Yoga 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 Mohini Badrinath Nagre |
| Designation |
Md scholar panchakarma |
| Affiliation |
Sumatibhai Shah Ayueveda Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurveda Mahavidyalaya Malwadi Hadapsar Pune Opd No 6 Department of Panchakarma Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8975983885 |
| Fax |
|
| Email |
mohininagre8895@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Avhad |
| Designation |
Assistant Professor of Department of Panchakarma |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalaya |
| Address |
Sumatibhai Shah Ayueveda Mahavidyalaya Malwadi Hadapsar Pune OPD No 6 department of Panchakarma sane guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9890608788 |
| Fax |
|
| Email |
drvandanapalve@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohini Badrinath Nagre |
| Designation |
M.D. Scholar Panchakarma |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurveda Mahavidyalaya Malwadi Hadapsar Pune OPD NO 6 Department of Panchakarma Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8975983885 |
| Fax |
|
| Email |
mohininagre8895@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Panchakarma Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 |
| 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 Mohini Badrinath Nagre |
Sane Guruji Arogya Kendra |
OPD No 6 Department Of Panchakarma Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
8975983885
mohininagre8895@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY HUMANS WITH PROBLEMS SUCH AS AMLAPITTA, KUSHTHA, KAPHAJANYA VYADHI AND ALSO IN HEALTHY INDIVIDUAL FOR SHARIR SHODHAN |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Madanphaladi yoga, Reference: sharangdhara samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Madanphala phanta, Reference: sharangdhara samhita, Route: Oral, Dosage Form: Phanta, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Vamana Arha
2.Snehapana Arha
3.Patients In Niram Avastha Of Doshas
4.Patients Who Willing To Undergo Vamana Karma For Swastharakshan
|
|
| ExclusionCriteria |
| Details |
1.Pregnant Women And Lactating Mother
2.Other Systematic Disorders Which May Interfere The Treatment Of This Study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Access The Vamana Karma With Madanphaladi Yoga |
Vamana Vega Will be Observed After The Yoga Administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Access The Vamana Karma With Madanphala Phanta Yoga |
Vamana Vega Will Be Observed After The Yoga Administration |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
06/01/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS IS A COMPARATIVE CLINICAL STUDY OF TWO DRUGS MADANPHALADI YOGA AND MADANPHALA PHANTA YOGA IN VAMANA KARMA. THE PRIMARY OBJECTIVE IS TO ACCESS THE VAMANA KARMA WITH MADANPHALADI YOGA AND MADANPHALA PHANTA YOGA. ONE GROUP OF PATIENTS OF VAMANA KARMA WILL BE GIVEN MADANPHALADI YOGA. SECOND GROUP OF PATIENT WILL BE GIVEN MADANPHALA PHANTA YOGA. OBSERVATIONS WILL BE DRAWN FROM THE OUTCOME OF THE TREATMENT. |