Clinical trial NCT01356355: Study of Herbmed Plus in Ureteral Stent Discomfort
Official title: Double Blind Exploratory Three Arm Randomized Trial to Evaluate the Safety and Efficacy of Herbal Preparation 'Herbmed Plus' in Ureteral Stent Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ureteral Stent Discomfort
Keywords: Stent discomfort
Herbmed plus
Tolterodine
Lead sponsor: Amai Charitable Trust
Sponsor class: OTHER
First posted: 2011-05-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ?

Eligibility criteria: 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.

Primary outcomes:
measure: Comparative study for Safety , Efficacy of Herbmed plus and tolterodine in management of ureteral stent discomfort.
timeFrame: 3weeks to 3 months
Secondary outcomes:
measure: Tolerability of herbmed plus in management of ureteral stent discomfort
timeFrame: 3 weeks to 3 months
Other outcomes:
Locations:
city: Pune
country: India
facility: AMAI Charitable Trust's ACE Hospital Pune
state: Maharashtra
Study officials:
affiliation: AMAI CHARITABLE TRUST (AMAI CHARITABLE TRUST'S ACE HOSPITAL PUNE)
name: SURESH B PATANKAR, MS,MCH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patankar S, Dobhada S, Bhansali M, Khaladkar S, Modi J. A prospective, randomized, controlled study to evaluate the efficacy and tolerability of Ayurvedic formulation "varuna and banana stem" in the management of urinary stones. J Altern Complement Med. 2008 Dec;14(10):1287-90. doi: 10.1089/acm.2008.0189.