Health Condition 1: null- Patients with unilateral/bilateral ureteral stent
Conditions
Interventions
Intervention1: Herbmed plus: 1capsule of herbmed plus 500 mg {Consisting of :
i) Varun (Crataeva nurvala Buch-ham )
ii) Banana (Musa Paradisiaca Linn.)
iii) Aghada (Achyranthes aspera Linn. )
i
Sponsors
ACE Hospital AMAI Charitabl Trust Pune
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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
| Measure | Time frame |
|---|---|
| - To evaluate the tolerability of ayurvedic preparation in management of ureteral stent discomfort - To know whether the ayurvedic preparation can reduce the requirement of analgesics or not - To know whether the ayurvedic preparation can replace the use of analgesics/ anti cholinergics in relieving ureteral stent discomfort ? Timepoint: 3 weeks to 3 months | — |
Countries
India
Contacts
Public ContactDr Suresh Balkrishna Patankar
Chairman of AMAI Trust
Outcome results
None listed