Herbmed plus IN THE TREATMENT OF STENT RELATED DISCOMFORT AND DIFFICULTIES IN PASSING URINE
- Conditions
- Health Condition 1: null- Patients with unilateral/bilateral ureteral stent
- Registration Number
- CTRI/2011/09/002006
- Lead Sponsor
- ACE Hospital AMAI Charitabl Trust Pune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
1)Absence of urinary tract infection
2)Absence of lower urinary tract symptoms
3)Absence of urethral catheter
4) Patients with unilateral/bilateral ureteral stent
5)Size of the stent ranging from 4/16 to 6/26.
6)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.
7) Able and willing to give written informed consent and comply with the
requirements of the study protocol
1)Patients having evidence of urinary tract infection.
2)Chronic medication with á-blockers or anticholinergics and severe complications during the procedure
3)_Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction.
4)Any other urogenital disorders.
5)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.
6) Kidney disease, including serum creatinine level 1.5 x ULN.
7) Subjects on herbal supplements (plant extracts preparations or herbal medicines etc.) within previous 3 months.
8) Participated in another clinical drug trial within 3 months before recruitment.
9) Pregnancy or breast feeding.
10) Evidence of significant uncontrolled concomitant disease which in the
Investigator?s opinion would preclude patient participation.
11)Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline.
12) Patients with psychiatric illness or other condition that would limit compliance with study requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -To compare the efficacy and safety of the Ayurvedic formulation against placebo and anti-cholinergic drugs in relieving the ureteral stent discomfortTimepoint: 3 weeks to 3 months
- Secondary Outcome Measures
Name Time Method -To evaluate the tolerability of ayurvedic preparation in management of ureteral stent discomfort <br/ ><br>-To know whether the ayurvedic preparation can reduce the requirement of analgesics or not <br/ ><br>-To know whether the ayurvedic preparation can replace the use of analgesics/ anti cholinergics in relieving ureteral stent discomfort ? <br/ ><br>Timepoint: 3 weeks to 3 months