Ureteral Stent DiscomfortPhase 2NCT01356355
Study of Herbmed Plus in Ureteral Stent Discomfort
A Phase 2 study testing Herbmed plus and Tolterodine in people with Ureteral Stent Discomfort, run by Dr .S.B.PATANKAR at 1 site in India.
Trial summary
The purpose of this study is to compare the efficacy and safety of the Ayurvedic formulation ,Herbmed Plus against placebo and anti-cholinergic drugs in relieving the ureteral stent discomfort. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ureteral Stent Discomfort
- What is being tested?
- Herbmed plus and Tolterodine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2012to Dec 2014
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients having evidence of urinary tract infection.
- Chronic medication with α-blockers or anticholinergics and severe complications during the procedure
- Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction.
- Any other urogenital disorders.
- Liver dysfunction, defined as total bilirubin >1.5 x the upper limit of Normal (ULN),Aspartate aminotransferase (AST/SGOT) > 2.5 x ULN, or alanine aminotransferase (ALT/SGPT) >2.5 x ULN.
- Kidney disease, including serum creatinine level >1.5 x ULN.
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- Subjects on herbal supplements (plant extracts preparations or herbal medicines etc.) within previous 3 months.
- Participated in another clinical drug trial within 3 months before recruitment.
- Pregnancy or breast feeding.
- Evidence of significant uncontrolled concomitant disease which in the Investigator's opinion would preclude patient participation.
- Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline.
- Patients with psychiatric illness or other condition that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Exploratory Three Arm Randomized Trial to Evaluate the Safety and Efficacy of Herbal Preparation 'Herbmed Plus' in Ureteral Stent Discomfort
The purpose of this study is to compare the efficacy and safety of the Ayurvedic formulation ,Herbmed Plus against placebo and anti-cholinergic drugs in relieving the ureteral stent discomfort.
Read the detailed description
- To evaluate the tolerability of ayurvedic preparation, Herbmed Plus in management of ureteral stent discomfort
- To know whether the ayurvedic preparation Herbmed Plus ,can reduce the requirement of analgesics or not
- To know whether the ayurvedic preparation ,Herbmed Plus can replace the use of analgesics/ anti cholinergics in relieving ureteral stent discomfort ?
- Conditions
- Ureteral Stent Discomfort
- Being tested
- Herbmed plus, Placebo, Tolterodine
- Keywords
- Stent discomfort, Herbmed plus, Tolterodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbmed plusDrug
one capsule of herbmed plus orally twice a day with meals till the ureteral stent is in situ.
PlaceboDrug
Also called sugar pills manufactured to mimic Herbmed plus
One capsule twice a day daily till ureteral stent in situ
TolterodineDrug
Also called Torq SR, Terol LA
One capsule twice a day daily till ureteral stent in situ
| Study group | Role | What they receive |
|---|---|---|
| Herbmed plus | Experimental | One capsule twice a day daily till ureteral stent in situ Receives: Drug: Herbmed plus |
| Placebo | Placebo comparator | One capsule twice a day daily till ureteral stent in situ Receives: Drug: Placebo |
| Tolterodine | Active comparator | One capsule twice a day daily till ureteral stent in situ Receives: Drug: Tolterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative study for Safety , Efficacy of Herbmed plus and tolterodine in management of ureteral stent discomfort.
-To compare the efficacy and safety of the Herbmed plus against placebo and anti-cholinergic drugs in relieving the ureteral stent discomfort viz.Dysuria, Urgency Frequency,Haematuria,Loin and suprapubic pain ,consumption of analgesics.
Measured: 3weeks to 3 months
Secondary outcomes (1)
Tolerability of herbmed plus in management of ureteral stent discomfort
- To evaluate the tolerability of Herbmed Plus in management of ureteral stent discomfort
- To know whether the Herbmed Plus can reduce the requirement of analgesics or not
- To know whether the Herbmed Plus can replace the use of analgesics/ anti cholinergics in relieving ureteral stent discomfort ?
Measured: 3 weeks to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startApr 2012
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ureteral Stent DiscomfortStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr .S.B.PATANKAR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr .S.B.PATANKAR, Amai Charitable Trust
- Investigators
- SURESH B PATANKAR, MS,MCH, Principal investigator, AMAI CHARITABLE TRUST (AMAI CHARITABLE TRUST'S ACE HOSPITAL PUNE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356355
- Sponsor's protocol ID
- ACE/HMP-02
- Status last verified
- Jan 2016
- First submitted
- 16 May 2011
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Patankar S, Dobhada S, Bhansali M, Khaladkar S, Modi J. A prospective, randomized, controlled study to evaluate the efficacy and tolerability of Ayurvedic formulation "varuna and banana stem" in the management of urinary stones. J Altern Complement Med. 2008 Dec;14(10):1287-90. doi: 10.1089/acm.2008.0189.
PubMed 19040391
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Exploratory Three Arm Randomized Trial to Evaluate the Safety and Efficacy of Herbal Preparation 'Herbmed Plus' in Ureteral Stent Discomfort
- ClinicalTrials.gov ID
- NCT01356355
- Acronym / sponsor ID
- ACE/HMP-02
- Conditions
- Ureteral Stent Discomfort
- Keywords
- Stent discomfort, Herbmed plus, Tolterodine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Dr .S.B.PATANKARUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 May 2011 (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.
The purpose of this study is to compare the efficacy and safety of the Ayurvedic formulation ,Herbmed Plus against placebo and anti-cholinergic drugs in relieving the ureteral stent discomfort.
Detailed description
- To evaluate the tolerability of ayurvedic preparation, Herbmed Plus in management of ureteral stent discomfort
- To know whether the ayurvedic preparation Herbmed Plus ,can reduce the requirement of analgesics or not
- To know whether the ayurvedic preparation ,Herbmed Plus can replace the use of analgesics/ anti cholinergics in relieving ureteral stent discomfort ?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Herbmed plus | Experimental | Drug: Herbmed plusOne capsule twice a day daily till ureteral stent in situ |
| Placebo | Placebo comparator | Drug: PlaceboOne capsule twice a day daily till ureteral stent in situ |
| Tolterodine | Active comparator | Drug: TolterodineOne capsule twice a day daily till ureteral stent in situ |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Patients having evidence of urinary tract infection.
- Chronic medication with α-blockers or anticholinergics and severe complications during the procedure
- Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction.
- Any other urogenital disorders.
- Liver dysfunction, defined as total bilirubin >1.5 x the upper limit of Normal (ULN),Aspartate aminotransferase (AST/SGOT) > 2.5 x ULN, or alanine aminotransferase (ALT/SGPT) >2.5 x ULN.
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 |
|---|---|---|
| Herbmed plusone capsule of herbmed plus orally twice a day with meals till the ureteral stent is in situ. | Drug | Herbmed plus |
| PlaceboAlso: sugar pills manufactured to mimic Herbmed plusOne capsule twice a day daily till ureteral stent in situ | Drug | Placebo |
| TolterodineAlso: Torq SR, Terol LAOne capsule twice a day daily till ureteral stent in situ | Drug | Tolterodine |
Primary outcome
Comparative study for Safety , Efficacy of Herbmed plus and tolterodine in management of ureteral stent discomfort.
Time frame: 3weeks to 3 months
-To compare the efficacy and safety of the Herbmed plus against placebo and anti-cholinergic drugs in relieving the ureteral stent discomfort viz.Dysuria, Urgency Frequency,Haematuria,Loin and suprapubic pain ,consumption of analgesics.
1 secondary outcome
Tolerability of herbmed plus in management of ureteral stent discomfort
Time frame: 3 weeks to 3 months
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 5 Jan 2016.
- Background: PubMed 19040391Patankar S, Dobhada S, Bhansali M, Khaladkar S, Modi J. A prospective, randomized, controlled study to evaluate the efficacy and tolerability of Ayurvedic formulation "varuna and banana stem" in the management of urinary stones. J Altern Complement Med. 2008 Dec;14(10):1287-90. doi: 10.1089/acm.2008.0189.
Related trials for Ureteral Stent Discomfort
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Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
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.
SURESH B PATANKAR, MS,MCH principal investigator
AMAI CHARITABLE TRUST (AMAI CHARITABLE TRUST'S ACE HOSPITAL PUNE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Herbmed plus and Tolterodine in people with Ureteral Stent Discomfort, run by Dr .S.B.PATANKAR at 1 site in India.
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 0 inclusion and 12 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 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Comparative study for Safety , Efficacy of Herbmed plus and tolterodine in management of ureteral stent discomfort. (time frame: 3weeks to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01356355, which also lists 1 linked publication.
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 5 Jan 2016.