| CTRI Number |
CTRI/2021/02/031055 [Registered on: 05/02/2021] Trial Registered Prospectively |
| Last Modified On: |
22/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE EFFECTS OF KATI BASTI(RETAINING OIL IN LOWER BACK) WITH MOORCHITA TAILA(MEDICATED OIL) AND ERANDAKARKATI TAILA( UNRIPE PAPAYA OIL) IN SCIATICA |
|
Scientific Title of Study
|
AN OPEN LABEL DOUBLE ARM RANDOMISED STUDY TO COMPARE THE EFFECT OF KATIBASTI WITH MOORCHITA TAILA AND KATI BASTI WITH ERANDAKARKATI TAILA IN GRIDHRASI VIS-À-VIS SCIATICA |
| 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 S Triveni Manju |
| Designation |
Post Graduate Scholar |
| Affiliation |
SKAMCH RC |
| Address |
DEPARTMENT OF PANCHAKARMA SKAMCH RC Vijayanagar,Bangalore,KARNATAKA
DEPARTMENT OF PANCHAKARMA SKAMCH RC Vijayanagar,Bangalore,KARNATAKA
Bangalore
KARNATAKA
560104
India |
| Phone |
09710842039 |
| Fax |
|
| Email |
trivenimanju88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Kumar K N |
| Designation |
professor |
| Affiliation |
SKAMCH RC |
| Address |
DEPARTMENT OF PANCHAKARMA SKAMCH RC Vijayanagar,Bangalore,KARNATAKA
DEPARTMENT OF PANCHAKARMA SKAMCH RC Vijayanagar,Bangalore,KARNATAKA
Bangalore
KARNATAKA
560104
India |
| Phone |
9845617690 |
| Fax |
|
| Email |
knv.gowda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinay Kumar K N |
| Designation |
professor |
| Affiliation |
SKAMCH RC |
| Address |
DEPARTMENT OF PANCHAKARMA SKAMCH RC Vijayanagar,Bangalore,KARNATAKA
DEPARTMENT OF PANCHAKARMA SKAMCH RC Vijayanagar,Bangalore,KARNATAKA
Bangalore
KARNATAKA
560104
India |
| Phone |
9845617690 |
| Fax |
|
| Email |
knv.gowda@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr S Triveni Manju |
| Address |
SKAMCH RC VIJAYANAGAR
BANGALORE KARNATAKA |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Kiran M Goud |
SKAMCH RC |
DEPARTMENT OF PANCHAKARMA SKAMCH RC Vijayanagar,Bangalore,KARNATAKA
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCH RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G541||Lumbosacral plexus disorders. Ayurveda Condition: GRIDHRASI, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kati basti with Erandakarkati taila |
KATI BASTI WITH ERANDAKARKATI TAILA WILL BE ADMINISTERED TO THE PATIENTS FOR 30 MINUTES FOR 7 CONSECUTIVE DAYS |
| Comparator Agent |
KATI BASTI WITH MOORCHITA TAILA |
KATI BASTI WITH MOORCHITA TAILA WILL BE ADMINISTERED TO THE PATIENTS FOR 30 MINUTES FOR 7 CONSECUTIVE DAYS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting with lakshanas of Gridhrasi
Subjects presenting with clinical features of Sciatica
Subjects fit for Kati Basti
|
|
| ExclusionCriteria |
| Details |
Subjects with fractures of Lumbar Spine Spinal Tumor and Tuberculosis of Vertebra
Subjects embedded with any metallic implant
Subjects with any systemic disease that may interfere with the course of treatment
|
|
|
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 |
| TO COMPARE THE THERAPEUTIC EFEFCT OF KATI BASTI WITH MOORCHITA TAILA AND ERANDAKARKATI TAILA IN GRIDHRASI |
7 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE THERAPEUTIC EFEFCT OF KATI BASTI WITH MOORCHITA TAILA AND ERANDAKARKATI TAILA IN GRIDHRASI |
7 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
16/02/2021 |
| 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="11"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ayurveda offers ample of better options in the management of Sciatica. Wherein special emphasis is given to Snehana and Swedana as the modalities of treatment which occupies the prime place in the domain of Chikitsa Sutra of Vata Vyadhi. Hence forth, by keeping in mind the concept of Snehana and Swedana employed in Vata vyadhi , a Snigdha Swedana modality of treatment in the form of Kati Basti with Erandakarkati Taila, a Taila prepared using unripen fruit of Erandakarkati is postulated. Hence, a clinical study has been undertaken to evaluate the efficacy of Kati Basti with Erandakarkati Taila as well as to compare its effect with Katibasti with Moorchita Taila in the management of Gridhrasi vis-a-vis Sciatica. |