| CTRI Number |
CTRI/2025/01/079613 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Diagnostic
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the variation in the serum electrolytes and lipid profile in the course of vaman karma ( Vomiting) |
|
Scientific Title of Study
|
Analytical study to assess the variation in the serum electrolytes and lipid profile in the course of vaman karma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved studies and Research Shri Krishna Ayush University Kurukshetra |
| Address |
98 Department of Rog Nidana Evum Vikriti Vigyan Faculty of Ayurved Institute for Ayurved studies and Research Shri Krishna Ayush University Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9992870955 |
| Fax |
|
| Email |
pikuv28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Randhir Singh |
| Designation |
Associate Professor |
| Affiliation |
Institute for Ayurved studies and Research Shri Krishna Ayush University Kurukshetra |
| Address |
94 Department of Rog Nidana Evum Vikriti Vigyan Faculty of Ayurved Institute for Ayurved studies and Research Shri Krishna Ayush University Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7015167849 |
| Fax |
|
| Email |
singhrandhir13476@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Randhir Singh |
| Designation |
Associate Professor |
| Affiliation |
Institute for Ayurved studies and Research Shri Krishna Ayush University Kurukshetra |
| Address |
94 Department of Rog Nidana Evum Vikriti Vigyan Faculty of Ayurved Institute for Ayurved studies and Research Shri Krishna Ayush University Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7015167849 |
| Fax |
|
| Email |
singhrandhir13476@gmail.com |
|
|
Source of Monetary or Material Support
|
| Umri Road Sector 8
Institute for Ayurved studies and Research Shri Krishana AYUSH University kurukshetra Haryana 136118 india
|
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved studies and Research Faculty of Ayurved kurukshetra |
| Address |
Shri Krishna Ayush University Sector 8 Umri Road kurukshetra |
| Type of Sponsor |
Government 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 Priyanka |
Institute of Ayurved studies and research shri krishana AYUSH university hospital |
Room No 71 first floor Institute of Ayurved studies and research shri krishana AYUSH university hospital umri road Sec 8, Kurukshetra
Kurukshetra
HARYANA |
9992870955
pikuv28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee of University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N979||Female infertility, unspecified. Ayurveda Condition: VANDHYA, (2) ICD-10 Condition:J459||Other and unspecified asthma. Ayurveda Condition: SVASAH, (3) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: TVAGGATAKUSHTHAH, (4) ICD-10 Condition:F209||Schizophrenia, unspecified. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Vaman karma | (Procedure Reference: Charak Samhita Sutrasthana chapter number 15, Procedure details: Purvkarma- Deepana, pachana,snehpana for 7days
Pardhana karma- Vaman karma (aakanthpana with godugdh & Madanphal is used as a vamak dravya)
Pashchat karma- Sansarjan karma for 7days)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All the patients of Vaman karma presenting with Samyak Shudhi Lakshana
Patient Irrespective of age gender and religion Patients indicated to Vaman karma
Patients with willing consent for the study |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Varitations might be there in serum electrolytes and lipid profile during the course of
vaman karma which might get corrected after pashchat karma |
1st- 0 Day
2nd- 8 Day
3rd- 10 Day
4th- 17 Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The collected and analyzed data will be provided to the panchkarma Physicians and
other Physicians who are working as Panchkarma Physicians for better planning and management of Vaman Karma
|
Before Snehapan (Day 0)
After Snehapan (Day 8)
After Vaman karma (Day 10)
After Sansarjan karma(Day 17)
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
08/02/2025 |
| 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
|
In the previous studies, no work has been done on this concept. But,
some work related to Samshodhana i.e. Vaman and Virechana karma on lipid profile is carried out.
So, this study will analyze the variation in the serum electrolytes and lipid profile during the course
of vaman karma. As per the Charak samhita sutrasthana chapter 15 vaman karma is performed through poorvakarma, pradhana karma, pashchat karma. But, in this study vaman karma is performed by panchkarma physician, this study will only analyze the serum electrolytes and lipid profile by taking the blood sample of the patient who undergoes vaman karma.
|