Herbmed plus IN THE TREATMENT OF STENT RELATED DISCOMFORT AND DIFFICULTIES IN PASSING URINE

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2011
INTERVENTION: 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. ) iv) Yav ((Hordeum vulgare Linn. ) } orally twice a day with meals till the ureteral stent is in situ. Control Intervention1: Anti‐cholinergic: traditional anti‐cholinergic drug i.e. tolterodine 2 mg sustained release capsule twice a day, after meal till the ureteral stent is in situ Control Intervention2: placebo: Placebo 1 capsule (of 500 mg) orally twice a day after meals till the ureteral stent is in situ CONDITION: Patients with unilateral/bilateral ureteral stent PRIMARY OUTCOME: ‐ To compare the efficacy and safety of the Ayurvedic formulation against placebo and anti‐cholinergic drugs in relieving the ureteral stent discomfort‐‐‐‐‐‐Timepoint: 3 weeks to 3 months SECONDARY OUTCOME: ‐ 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 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
Epistemonikos ID: 51a41e29dbbfc1997742e3f3add3b3139c1c04ae
First added on: Aug 22, 2024