Study of Herbmed Plus in Ureteral Stent Discomfort

Dr .S.B.PATANKAR

Status and phase: Completed; Phase 2

Conditions: Ureteral Stent Discomfort

Treatments: Drug: Tolterodine; Drug: Placebo; Drug: Herbmed plus

Study type: Interventional

Funder types: Other

Identifiers

NCT01356355

ACE/HMP-02

Details and patient eligibility

About

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.

Full 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 ?

Enrollment: 140 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 3 patient groups, including a placebo group

Herbmed plus

Experimental group

Description:

One capsule twice a day daily till ureteral stent in situ

Treatment:

Drug: Herbmed plus

Placebo

Placebo Comparator group

Description:

One capsule twice a day daily till ureteral stent in situ

Treatment:

Drug: Placebo

Tolterodine

Active Comparator group

Description:

One capsule twice a day daily till ureteral stent in situ

Treatment:

Drug: Tolterodine