| CTRI Number |
CTRI/2024/04/065957 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
An observational study on changes in serum electrolytes after Virechankarma(Therapeutic purgation) |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY ON CHANGES IN SERUM ELECTROLYTES AFTER VIRECHANKARMA |
| 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 Maitri Jagdishbhai Parmar |
| Designation |
P G SCHOLAR |
| Affiliation |
J.S. Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital |
| Address |
Department of panchakarma,
J S Ayurveda Mahavidyalaya,
College road,
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
7228062390 |
| Fax |
|
| Email |
parmarmaitri45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Kalapi B Patel |
| Designation |
Professor and HOD Department of Panchakarma |
| Affiliation |
J.S. Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital |
| Address |
Department of panchakarma,
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 |
Dr Maitri Jagdishbhai Parmar |
| Designation |
P G Scholar |
| Affiliation |
J.S. Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital |
| Address |
Department of panchakarma,
J S Ayurveda Mahavidyalaya,
College road,
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
7228062390 |
| Fax |
|
| Email |
parmarmaitri45@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar ayurved teaching pharmacy of J.S.Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidyalaya |
| Address |
J S Ayurveda Mahavidyalaya,
College road,
Nadiad-387001 |
| 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 Maitri Jagdishbhai Parmar |
P D Patel Ayurveda Hospital |
Department of Panchakarma,
J S Ayurveda Mahavidyalaya,
College road,
Nadiad-387001
Kheda
GUJARAT |
7228062390
parmarmaitri45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, MAM University- Nadiad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R69||Illness, unspecified. Ayurveda Condition: DOSHAVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients indicated for the virechana karma.
2. Patients undergoing virechana karma.
3. Patient having samyaka virechana karma. |
|
| ExclusionCriteria |
| Details |
1. Patients contraindicated for virechanakarma.
2. Patient who have ayoga and atiyoga lakshanas of
virechana karma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Virechana karma do not produce the imbalance of serum electrolytes. |
Before and after Samyak virechana karma |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
17/06/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Samyak Virecana
Karma does not cause patients to experience an imbalance in their serum
electrolytes, according to the data analysis and appropriate observations of the patients taking the treatment.
|