Study of Herbmed Plus in Ureteral Stent Discomfort

Phase 2

Completed

• Conditions: Ureteral Stent Discomfort
• Interventions: Drug: Herbmed plus; Drug: Placebo; Drug: Tolterodine

• Registration Number: NCT01356355
• Lead Sponsor: Dr .S.B.PATANKAR

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 ?

Study Timeline

• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-18
• Study First Posted: 2011-05-19
• Study Start: 2012-04
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Herbmed plus	Herbmed plus	One capsule twice a day daily till ureteral stent in situ
Placebo	Placebo	One capsule twice a day daily till ureteral stent in situ
Tolterodine	Tolterodine	One capsule twice a day daily till ureteral stent in situ

Primary Outcome Measures

Name	Time	Method
Comparative study for Safety , Efficacy of Herbmed plus and tolterodine in management of ureteral stent discomfort.	3weeks to 3 months	-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.

Secondary Outcome Measures

Name	Time	Method
Tolerability of herbmed plus in management of ureteral stent discomfort	3 weeks to 3 months	* 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 ?

Trial Locations

Locations (1)

AMAI Charitable Trust's ACE Hospital Pune; 🇮🇳 Pune, Maharashtra, India