CTRI

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CTRI Number

CTRI/2017/08/009504 [Registered on: 28/08/2017] Trial Registered Prospectively

Last Modified On:

25/08/2017

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Clinical study on local application of oil on lower back and anal administration of drugs in the management of lower backache

Scientific Title of Study

A comparative clinical study to evaluate the efficacy of Matra basti and Kati basti with Sahachara taila in the management of Katigraha w.s.r. to lumbar spondylosis

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Sarvesh Kumar Singh
Designation	Assistant Professor
Affiliation	National Institute Of Ayurveda Jaipur India
Address	Room no.2,Department of Panchakarma, National Institute of Ayurveda Jaipur Jaipur RAJASTHAN 302002 India
Phone	8739860237
Fax	8739860237
Email	sarveshksingh21@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sarvesh Kumar Singh
Designation	Assistant Professor
Affiliation	National Institute Of Ayurveda Jaipur India
Address	Room no.2,Department of Panchakarma, National Institute of Ayurveda Jaipur Jaipur RAJASTHAN 302002 India
Phone	8739860237
Fax	8739860237
Email	sarveshksingh21@gmail.com

Details of Contact Person
Public Query

Name	Dr Suman Dadhich
Designation	M.D. Scholar
Affiliation	National Institute Of Ayurveda Jaipur India
Address	Room no.2,Department of Panchakarma, National Institute of Ayurveda Jaipur Jaipur RAJASTHAN 302002 India
Phone	7610906425
Fax
Email	suman.dadhich10@gmail.com

Source of Monetary or Material Support

National institute of Ayurveda Jorawar Singh Gate Jaipur,Rajasthan, India

Primary Sponsor

Name	National Institute of Ayurveda Jaipur
Address	National Institute of Ayurveda Jorawar Singh Gate,Madhav Vilas hospital,Jaipur
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sarvesh Kumar Singh	National Institute of Ayurveda Jaipur	O.P.D. No-2, Department of Panchakarma,National Institute of Ayurveda, Jorawar Singh Gate,Jaipur Jaipur RAJASTHAN 08739860237 O.P.D. No-2, Department of Panchakarma,National Institute of Ayurveda, Jorawar Singh Gate,Jaipur Jaipur RAJASTHAN Jaipur RAJASTHAN	8739860237 sarveshksingh21@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethics commitee, National Institute of Ayurveda Jaipur	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	Lumbar spondylosis,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Kati basti with Sahachar Taila	Kati basti with Sahachar Taila will be applied locally on lumbosacral region, once daily for 45 minutes and for 16 days
Intervention	Matra basti(oily medicated enema) with Sahchar oil	Matra basti in the dose of 75 ml once in a day by anal route will be given for 16 days

Inclusion Criteria

Age From	40.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patients fulfilling the diagnostic criteria[ Walking disability(10m walking test),tenderness, with confirmative degenerative changes in X-rays of lumber spine AP & L view, fulfilling the Modified Oswestry low back pain disability index(MOLBPDI).] - Patient without any anatomical deformity -patient willing to sign the consent for study participation

ExclusionCriteria

Details

Lumber carcinoma, Diabetes Mellitus, Chronic Renal Failure, Rheumatoid Arthritis, Gout, Systemic Lupus Erythematosus, Tuberculosis in bone, Ankylosing Spondylosis, pregnancy, lactation or any other systemic illnesses.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Case Record Numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
improvement in MOLBPDI- Modified Oswestry low back pain disability index	30 days

Secondary Outcome

Outcome	TimePoints
improvement in Visual analogue scale,improvement in 10 meter walking test and improvement in lane grading of lumbar disc degeneration scale for degenerative changes.	1 month

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)

01/12/2017

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 Applicable

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)?

Brief Summary

This study is a open lebel parallel group trial comparing the efficacy of Matra basti(oily medicated enema) and Kati basti (local application and retention of oiil in lumbosacral region) with Sahachar taila in the management of Katigraha w.s.r. to Lumbar spondylosis. In one group Matra basti in the dose of 75 ml per day for 16 days will be given. In another group kati basti with Sahachar oil will be applied for 16 days. The trial will be conducted in National Institute of Ayurveda Jaipur India with primary outcome of improvement in modified oswestry low back pain disability index.