| CTRI Number |
CTRI/2019/01/016957 [Registered on: 08/01/2019] Trial Registered Prospectively |
| Last Modified On: |
03/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [treatment] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARATIVE CLINICAL STUDY ON VAITARANA BASTI WITH KATIBASTI AND VAITARANA BASTI WITH INTERFERENTIAL THERAPY IN THE MANAGEMENT OF GRIDHRASI W.S.R TO SCIATICA |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON VAITARANA BASTI WITH KATI BASTI AND VAITARANA BASTI WITH INTERFERENTIAL HEAT THERAPY (IFT) IN THE MANAGEMENT OF GRIDHRASI W.S.R TO SCIATICA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shruti K Kamath |
| Designation |
PG Scholar |
| Affiliation |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
NO 10 Pipeline Road RPC Layout Vijayanagara Banglore 560104
194 Kalavati 10th cross NGEF Layout Nagarabhavi Banglore
Bangalore
KARNATAKA
560104
India |
| Phone |
9620057967 |
| Fax |
|
| Email |
kamathshruti01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Vinay Kumar K N |
| Designation |
Reader |
| Affiliation |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
NO 10 Pipline Road RPC Layout Vijayanagara Bangalore 560104
NO 10 Pipline Road RPC Layout Vijayanagara Bangalore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9845617690 |
| Fax |
|
| Email |
knvgowda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinay Kumar K N |
| Designation |
Reader |
| Affiliation |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
NO 10 Pipline Road RPC Layout Vijayanagara Bangalore 560104
NO 10 Pipline Road RPC Layout Vijayanagara Bangalore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9845617690 |
| Fax |
|
| Email |
knvgowda@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR SHRUTI K KAMATH |
| Address |
Sri Kalabyraveshwara swamy Ayurvedic Medical College Hospital and Research Centre 10 Pipline Road RPC Layout Vijayanagara Bangalore 560104 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinay Kumar K N |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
NO 10 Pipline Road RPC Layout Vijayanagara Bangalore 560104
Bangalore
KARNATAKA |
9845617690
knvgowda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M519||Unspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
VAITARANA BASTI WITH INTERFERENTIAL THERAPY |
VAITARANA BASTI WITH INTERFERENTIAL THERAPY FOR 8 DAYS |
| Intervention |
VAITARANA BASTI WITH KATI BASTI |
VAITARANA BASTI WITH KATI BASTI FOR 8 DAYS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients Of Either Sex In Between Age Group 18-70 Years
Patients Presenting With Lakshanas Of Gridhrasi
Patients Presenting With The Clinical Features Of Sciatica
Patients Fit For Basti Karma
Patients Fit For Interferential Therapy
|
|
| ExclusionCriteria |
| Details |
Patients With Systemic Disorders That May Interfere With The Course Of Treatment
Patients With Fractures And Dislocations Of Lumbar Spine
Patients Embedded With Metallic Implants
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EFFICACY OF THE VAITARANA BASTI WITH KATI BASTI OR WITH INTERFERENTIAL THERAPY OVER SUBJECTIVE AND OBJECTIVE CRITERIA OF GRIDHRASI |
VAITARANA BASTI WITH KATI BASTI - 8 DAYS
VAITARANA BASTI WITH INTERFERENTIAL THERAPY - 8 DAYS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
na |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/01/2019 |
| Date of Study Completion (India) |
19/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
GRIDHRASI IN CONTEMPORARY SCIENCE IS COMMONLY IDENTIFIED WITH SCIATICA WHERE THE LIFETIME INCIDENCE VARIES FROM 13%-40%. THE PRESENT STUDY IS DESIGNED TO EVALUATE THE EFFICACY OF VAITARANA BASTI WITH KATI BASTI AND VAITARANA BASTI WITH INTERFERENTIAL THERAPY IN THE MANAGEMENT OF GRIDHRASI, WHERE VAITARANA BASTI HAS SHULA, ANAHA, AMA HARA ASWELL AS VATAHARA PROPERTY AS MENTIONED IN VANGASENA SAMHITA, KATI BASTI ACTS AS SNIGDHA SWEDA IS DONE WITH BALA TAILA MENTIONED IN BHELA SAMHITA AND INTERFERNTIAL THERAPY WHICH IS AN ELECTROTHERAPY IS SAID TO RELIEVE PAIN, ENHANCE CIRCULATION AND REDUCE OEDEMA. |