Ureteral Stent Discomfort
Conditions
Keywords
Stent discomfort, Herbmed plus, Tolterodine
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.
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 ?
Interventions
DRUGHerbmed plus
one capsule of herbmed plus orally twice a day with meals till the ureteral stent is in situ.
DRUGPlacebo
One capsule twice a day daily till ureteral stent in situ
DRUGTolterodine
One capsule twice a day daily till ureteral stent in situ
Sponsors
Dr .S.B.PATANKAR
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
The following patients would be enrolled in the study: 1. Age 18-75 years (Both inclusive) 2. Absence of urinary tract infection 3. Absence of lower urinary tract symptoms 4. Absence of urethral catheter 5. Patients with unilateral/bilateral ureteral stentSize 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. 7Able and willing to give written informed consent and comply with the requirements of the study protocol
Exclusion criteria
1. Patients having evidence of urinary tract infection. 2. Chronic medication with α-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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparative study for Safety , Efficacy of Herbmed plus and tolterodine in management of ureteral stent discomfort. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of herbmed plus in management of ureteral stent discomfort | 3 weeks to 3 months | * 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 ? |
Countries
India
Outcome results
None listed