Role of Uttarbasti in the Management of Mutra Marga Sanko... | NCT00535717

Studies
Role of Uttarbasti in the Management of Mutra Marga Sankoch (Urethral Stricture)

NCT00535717

Sponsor

Maharashtra University of Health Sciences

Status

Completed

Last Update Posted

Sep 26, 2007Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Urethral Stricture

Interventions

uttarbasti (per urethral administration of medicated oil )

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 25, 2007

First Submission Date that Met QC Criteria

Sep 25, 2007

First Posted Date

Sep 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2007

Last Update Posted Date

Sep 26, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Uttarbasti is per urethral administration of medicated oil which has been recommended by Sushrut for urinary track disorders.

As far as conventional surgery is concerned urethral stricture still remains a challenge due to post procedural high recurrences and complications

Uttarbasti being almost non invasive, with minimum recurrences and most economical, easy to practice OPD procedure, can be the treatment of choice in the management of urethral stricture.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
uttarbasti (per urethral administration of medicated oil )	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

K/C/O Urethral Stricture of either sex and from all age groups.

Exclusion Criteria:

With acute UTI.
DM.
Neoplasms of lower urinary tract
BEP.
With impacted calculus in urethra and bladder neck.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rajendra H Amilkanthwar, M.D.(Ayu.)	Maharashtra university of health sciences, Nashik (INDIA)	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014525	Urethral Stricture

Ancestor Terms

ID	Term
D014524	Urethral Obstruction
D014522	Urethral Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided