Study of Herbmed Plus in Ureteral Stent Discomfort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-12-31

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.

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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 ?

Conditions

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Ureteral Stent Discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Herbmed plus

One capsule twice a day daily till ureteral stent in situ

Group Type EXPERIMENTAL

Herbmed plus

Intervention Type DRUG

one capsule of herbmed plus orally twice a day with meals till the ureteral stent is in situ.

Placebo

One capsule twice a day daily till ureteral stent in situ

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One capsule twice a day daily till ureteral stent in situ

Tolterodine

One capsule twice a day daily till ureteral stent in situ

Group Type ACTIVE_COMPARATOR

Tolterodine

Intervention Type DRUG

One capsule twice a day daily till ureteral stent in situ

Interventions

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Herbmed plus

one capsule of herbmed plus orally twice a day with meals till the ureteral stent is in situ.

Intervention Type DRUG

Placebo

One capsule twice a day daily till ureteral stent in situ

Intervention Type DRUG

Tolterodine

One capsule twice a day daily till ureteral stent in situ

Intervention Type DRUG

Other Intervention Names

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sugar pills manufactured to mimic Herbmed plus Torq SR Terol LA

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes