Study of Herbmed Plus in Ureteral Stent Discomfort

Study Overview
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Brief Summary
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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
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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 ?

Official Title
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Double Blind Exploratory Three Arm Randomized Trial to Evaluate the Safety and Efficacy of Herbal Preparation 'Herbmed Plus' in Ureteral Stent Discomfort

Conditions
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Ureteral Stent Discomfort

Intervention / Treatment
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* Drug: Herbmed plus
* Drug: Placebo
* Drug: Tolterodine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:The following patients would be enrolled in the study: 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. 7Able and willing to give written informed consent and comply with the requirements of the study protocol Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Herbmed plus<br>One capsule twice a day daily till ureteral stent in situ | Drug: Herbmed plus<br>* one capsule of herbmed plus orally twice a day with meals till the ureteral stent is in situ.<br>|
| Placebo Comparator: Placebo<br>One capsule twice a day daily till ureteral stent in situ | Drug: Placebo<br>* One capsule twice a day daily till ureteral stent in situ<br>* Other names: sugar pills manufactured to mimic Herbmed plus;|
| Active Comparator: Tolterodine<br>One capsule twice a day daily till ureteral stent in situ | Drug: Tolterodine<br>* One capsule twice a day daily till ureteral stent in situ<br>* Other names: Terol LA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of herbmed plus in management of ureteral stent discomfort | 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 ? | 3 weeks to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tolterodine, Stent discomfort, Herbmed plus