| CTRI Number |
CTRI/2024/08/071955 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluate the Efficacy of Jalaukaavacharan and Paravat Shkritaadi Yog in the Prevention of Venous Thromboembolism |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF JALAUKAVACHARAN
WITH COMPARISON TO PARAVAT SHKRUTAADI YOG (ANUBHUTA YOG) IN THE
PREVENTION OF VENOUS THROMBOEMBOLISM W.S.R. TO DEEP VEIN THROMBOSIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hari Shankar |
| Designation |
PhD Scholar |
| Affiliation |
MMM. Govt. Ayurved college, Udaipur (Raj) |
| Address |
Shalya opd, M.M.M. govt. ayurved college UDAIPUR (Raj)
Udaipur
RAJASTHAN
313001
India |
| Phone |
9782538473 |
| Fax |
|
| Email |
harispaliwal287@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MAHESH DIXIT |
| Designation |
PROFESSOR |
| Affiliation |
Shalya opd, M.M.M. govt. ayurved college UDAIPUR (Raj) |
| Address |
Principal office, M.M.M. govt. ayurved college UDAIPUR (Raj)
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414245459 |
| Fax |
|
| Email |
prof.maheshdixit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hari Shankar |
| Designation |
PhD SCHOLAR |
| Affiliation |
Shalya opd, M.M.M. govt. ayurved college UDAIPUR (Raj) |
| Address |
Shalya opd, M.M.M. govt. ayurved college UDAIPUR (Raj)
Udaipur
RAJASTHAN
313001
India |
| Phone |
9782538473 |
| Fax |
|
| Email |
harispaliwal287@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College Udaipur (Raj) |
|
|
Primary Sponsor
|
| Name |
MADAN MOHAN MALVIYA GOVERNMENT AYURVED COLLEGE UDAIPUR |
| Address |
Madan Mohan Malviya Government Ayurved College Udaipur (Raj) |
| 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 |
| Hari Shankar |
Madan Mohan Malviya Government Ayurved College Udaipur |
Shalya opd, M.M.M. govt. ayurved college UDAIPUR (Raj) 313001
Udaipur
RAJASTHAN |
9782538473
harispaliwal287@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICAL COMMITTEE MMM GOVT AYRVED COLLEGE, UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I00-I99||Diseases of the circulatory system. Ayurveda Condition: SIRAJAGRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Jalaukaavacharan Pradhan Karma | (Procedure Reference: Vagbhat Samhita, Procedure details: Local Application )
(1) Medicine Name: Paravat Shkritaadi Yog, Reference: Charak Chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Duration: 28 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Paravat Shkritaadi Yog, Reference: Charak Chikitsa , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfill the diagnostic criteria.
2. Patients willing to sign the
consent form.
3. Patient is not suffering with any systemic
disorders |
|
| ExclusionCriteria |
| Details |
1. Unstable patients
2. HIV, Immune deficiency syndrome
3. Patient with uncontrolled Hypertension, Cardiac problem, diabetes mellitus and any systemic disorders.
4. Immunosuppressive medications
5. Previous participation in trial.
6. Refusal to give consent
7. Patients on therapeutic anticoagulation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain in calf region.
2. Tenderness in the calf region. |
2 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Acceptability / Tolerance to treatment.
2. Time to return work. |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study is to Coparative clinical study to evalute the efficacy of Jalaukavacharan with comparison to paravat shkrutaadi yog (Anubhut Yog) in the prevention of venous thromboembolism w.s.r. to Deep Vein Thrombosis. 20 patients will be treated in each group. |