| CTRI Number |
CTRI/2022/03/041058 [Registered on: 14/03/2022] Trial Registered Prospectively |
| Last Modified On: |
03/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Vrishchhiya Shaaka Malahara For Muscular Pain
|
|
Scientific Title of Study
|
A Clinical study to evaluate the vedanasthapna karma ( Analgesic Activity) of Vrishchhiya Shaaka Urtica dioica L in Muscular Pain.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KM Himani Rani |
| Designation |
PG SCHOLAR |
| Affiliation |
SDM College of Ayurveda Hassan |
| Address |
Shri Dhramsthala Manjunatheswara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
pin code 573201
Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
7307526262 |
| Fax |
|
| Email |
pg19115@sdmcahhassan.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep |
| Designation |
Head of Department Dravyaguna |
| Affiliation |
SDM College of Ayurveda Hassan |
| Address |
Shri Dhramsthala Manjunatheswara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
pin code 573201
Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9448203499 |
| Fax |
|
| Email |
drpradeepa@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
KM Himani Rani |
| Designation |
PG SCHOLAR |
| Affiliation |
SDM College of Ayurveda Hassan |
| Address |
Shri Dhramsthala Manjunatheswara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
pin code 573201
Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
7307526262 |
| Fax |
|
| Email |
pg19115@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Shri Dhramsthala Manjunatheswara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan |
|
|
Primary Sponsor
|
| Name |
Shri Dhramsthala Manjunatheswara College of Ayurveda and Hospital |
| Address |
Shri Dhramsthala Manjunatheswara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
pin code 573201
Karnataka |
| 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 Himani |
SDM College of Ayurveda and Hospital |
OPD AND IPD
DEPT OF Dravyaguna
Hassan
KARNATAKA |
7307526262
PG19115@SDMCAHHASSAN.ORG |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MUSCULAR PAIN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Ointment |
ointment will be given for 7 days BD
local appliction |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fulfilling the diagnostic criteria
Age between 20-70 years
Subject having muscle pain
Subjects of both gender |
|
| ExclusionCriteria |
| Details |
Subject which are not willing to take part in study
subject having muscle injury
subject having any skin disease at the site of pain
subject having chronic pain including systemic disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sing and Symptoms of Vedana will be assessed by giving suitable scoring after 7 days |
Sing and Symptoms of Vedana will be assessed by giving suitable scoring after 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The condition of the patient will be assessed by VAS (Visual Analog Scale) |
7 Days |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/03/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open label single arm, prospective, clinical study to know the vedanahara karma of Vrishchhiya Shaaka That will be conducted in India.The primary outcome measures will be VAS Scale Symptoms will be assessed on the 7th day of intervention |