Urethral StricturePhase 2NCT00535717
Role of Uttarbasti in the Management of Mutra Marga Sankoch (Urethral Stricture)
A Phase 2 study testing uttarbasti (per urethral administration of medicated oil ) in people with Urethral Stricture, run by Maharashtra University of Health Sciences.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- uttarbasti (per urethral administration of medicated oil )
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- K/C/O Urethral Stricture of either sex and from all age groups.
Who cannot join
- With acute UTI.
- DM.
- Neoplasms of lower urinary tract
- BEP.
- With impacted calculus in urethra and bladder neck.
About this study
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.
- Conditions
- Urethral Stricture
- Being tested
- uttarbasti (per urethral administration of medicated oil )
- Keywords
- Urethral stricture, Ayurvedic treatment, mutra marg sankoch, uttarbasti, Sesame oil, Honey, Rock salt
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uttarbasti (per urethral administration of medicated oil )Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Maharashtra University of Health Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Rajendra H Amilkanthwar, M.D.(Ayu.), Principal investigator, Maharashtra university of health sciences, Nashik (INDIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535717
- Sponsor's protocol ID
- MUHS RIA
- Status last verified
- Sep 2007
- First submitted
- 25 Sep 2007
- Last updated
- 26 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Uttarbasti in the Management of Mutra Marga Sankoch (Urethral Stricture)
- ClinicalTrials.gov ID
- NCT00535717
- Acronym / sponsor ID
- MUHS RIA
- Conditions
- Urethral Stricture
- Keywords
- Urethral stricture, Ayurvedic treatment, mutra marg sankoch, uttarbasti, Sesame oil, Honey, Rock salt
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Maharashtra University of Health SciencesUniversity, hospital or other
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- K/C/O Urethral Stricture of either sex and from all age groups.
Key exclusion criteria (5 listed)
- With acute UTI.
- DM.
- Neoplasms of lower urinary tract
- BEP.
- With impacted calculus in urethra and bladder neck.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uttarbasti (per urethral administration of medicated oil ) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajendra H Amilkanthwar, M.D.(Ayu.) principal investigator
Maharashtra university of health sciences, Nashik (INDIA)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing uttarbasti (per urethral administration of medicated oil ) in people with Urethral Stricture, run by Maharashtra University of Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2007.