| CTRI Number |
CTRI/2021/08/035349 [Registered on: 03/08/2021] Trial Registered Prospectively |
| Last Modified On: |
30/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ANALYSE THE EFFECT OF VISHATINDUKA TAILAM ON SCIATICA (BACK PAIN) |
|
Scientific Title of Study
|
PHARMACEUTICAL STANDARDISATION OF VISHATINDUKA TAILAM AND ITS EFFECT ON
GRIDHRASI |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Vanitha |
| Designation |
PG Scholar, Department of Rasashastra and bhaishajya kalpana |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Sri jayendra saraswathi ayurveda college and hospital, Nazarthpet,
Thiruvallur district
Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9790909862 |
| Fax |
|
| Email |
vanithavasanthan22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KL Virupaksha gupta |
| Designation |
Professor, Department of Rasashastra and bhaishajya kalpana |
| Affiliation |
Sri jayendra saraswathi ayurveda college and hospital |
| Address |
Sri jayendra saraswathi ayurveda college and hospital, Nazarthpet,
Thiruvallur district
Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
8555805497 |
| Fax |
|
| Email |
virupakshgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Vanitha |
| Designation |
PG Scholar, Department of Rasashastra and bhaishajya kalpana |
| Affiliation |
Sri jayendra saraswathi ayurveda college and hospital |
| Address |
Sri jayendra saraswathi ayurveda college and hospital, Nazarthpet,
Thiruvallur district
Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9790909862 |
| Fax |
|
| Email |
vanithavasanthan22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra saraswathi Ayurveda college and Hospital
|
|
|
Primary Sponsor
|
| Name |
Sri jayendra saraswathi ayurveda college and hospital |
| Address |
Sri jayendra saraswathi ayurveda college and hospital, Nazarthpet,
Thiruvallur district
Chennai |
| 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 V Vanitha |
Sri Jayendra Saraswathi Ayurveda College and Hospital, Department of RSBK |
Sri jayendra saraswathi ayurveda college and hospital, Nazarthpet,
Thiruvallur district
Chennai
Thiruvallur
TAMIL NADU |
9790909862
vanithavasanthan22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M543||Sciatica, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
vishatinduka tailam |
Effect of vishatinduka tailam in sciatica (back ache).
Dose - Quantity sufficient
Route of administration - External application |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient irrespective of Gender and Occupation will be selected.
Patient age between 18-60 years.
Patient willing for study and
follow up. |
|
| ExclusionCriteria |
| Details |
Patient suffering from Structural deformity like lordosis, kyphosis and
scoliosis (After
doing physical examination of back including inspection, palpation,
gait).
Patient under pediatric age group and those who are above 60
years.
Patient suffering from any systemic disease like diabetic mellitus,
hypertension,
thyroid dysfunction or the patient under any concomitant
medications.
Any neoplasms like osteoma and myeloma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SLR Test – Active and Passive
Schobers Test
Assessment will be done based on Oswestry low
back pain disability questionnaire. |
1 WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| analyse effect of vishatinduka tailam in sciatica |
2 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
05/08/2021 |
| 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="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To prepare and carry out the pharmaceutical study of Vishatinduka tailam as per Reference of
Bhasavarajiyam in vataroga nidhana lakshana chikitsadyaya.To analyse and standardize the
Vishatinduka tailam prepared. To carry out the clinical trial on Gridhirasi by using Vishatinduka
tailam.And to analyse whether vishatindukatailam is effective in pain relief. |