Study of Herbmed Plus in Ureteral Stent Discomfort

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

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.

Study Overview

• Status: Completed
• Conditions: Ureteral Stent Discomfort
• Intervention / Treatment: Drug: Herbmed plus; Drug: Placebo; Drug: Tolterodine

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India, 411004
      • AMAI Charitable Trust's ACE Hospital Pune

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr .S.B.PATANKAR
• Investigators: Principal Investigator: SURESH B PATANKAR, MS,MCH, AMAI CHARITABLE TRUST (AMAI CHARITABLE TRUST'S ACE HOSPITAL PUNE)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 18, 2011
• First Posted (Estimate): May 19, 2011

Study Record Updates

• Last Update Posted (Estimate): January 5, 2016
• Last Update Submitted That Met QC Criteria: January 4, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Tolterodine; Stent discomfort; Herbmed plus
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Tolterodine Tartrate
• Other Study ID Numbers: ACE/HMP-02