NCT01356355

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

2.4 years

First QC Date

May 16, 2011

Last Update Submit

January 4, 2016

Conditions

Ureteral Stent Discomfort

Keywords

Stent discomfortHerbmed plusTolterodine

Outcome Measures

Primary Outcomes (1)

  • 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.

    3weeks to 3 months

Secondary Outcomes (1)

  • Tolerability of herbmed plus in management of ureteral stent discomfort

    3 weeks to 3 months

Study Arms (3)

Herbmed plus

EXPERIMENTAL

One capsule twice a day daily till ureteral stent in situ

Drug: Herbmed plus

Placebo

PLACEBO COMPARATOR

One capsule twice a day daily till ureteral stent in situ

Drug: Placebo

Tolterodine

ACTIVE COMPARATOR

One capsule twice a day daily till ureteral stent in situ

Drug: Tolterodine

Interventions

Herbmed plusDRUG

one capsule of herbmed plus orally twice a day with meals till the ureteral stent is in situ.

Herbmed plus
PlaceboDRUG

One capsule twice a day daily till ureteral stent in situ

Also known as: sugar pills manufactured to mimic Herbmed plus
Placebo
TolterodineDRUG

One capsule twice a day daily till ureteral stent in situ

Also known as: Torq SR, Terol LA
Tolterodine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years (Both inclusive)
  • Absence of urinary tract infection
  • Absence of lower urinary tract symptoms
  • Absence of urethral catheter
  • Patients with unilateral/bilateral ureteral stentSize of the stent ranging from 4/16 to 6/26.
  • Patients of reproductive potential (males and females) and willing to use a reliable means of contraception (e.g. hormonal contraceptive patch, intrauterine device and physical barrier) throughout study participation.
  • Able and willing to give written informed consent and comply with the requirements of the study protocol

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AMAI Charitable Trust's ACE Hospital Pune

Pune, Maharashtra, 411004, India

Location

Related Publications (1)

  • 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.

    PMID: 19040391BACKGROUND

MeSH Terms

Interventions

Tolterodine Tartrate

Intervention Hierarchy (Ancestors)

PhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenols

Study Officials

  • SURESH B PATANKAR, MS,MCH

    AMAI CHARITABLE TRUST (AMAI CHARITABLE TRUST'S ACE HOSPITAL PUNE)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Amai Charitable Trust,ACE Hospital Pune

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 19, 2011

Study Start

April 1, 2012

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

IN(1)