Study of Herbmed Plus in Ureteral Stent Discomfort

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr .S.B.PATANKAR, Amai Charitable Trust
ClinicalTrials.gov Identifier:
NCT01356355
First received: May 16, 2011
Last updated: January 4, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Ureteral Stent Discomfort
Drug: Herbmed plus
Drug: Placebo
Drug: Tolterodine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind Exploratory Three Arm Randomized Trial to Evaluate the Safety and Efficacy of Herbal Preparation 'Herbmed Plus' in Ureteral Stent Discomfort

Resource links provided by NLM:


Further study details as provided by Amai Charitable Trust:

Primary Outcome Measures:
  • Comparative study for Safety , Efficacy of Herbmed plus and tolterodine in management of ureteral stent discomfort. [ Time Frame: 3weeks to 3 months ] [ Designated as safety issue: Yes ]
    -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:
  • Tolerability of herbmed plus in management of ureteral stent discomfort [ Time Frame: 3 weeks to 3 months ] [ Designated as safety issue: Yes ]
    • 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 ?


Enrollment: 140
Study Start Date: April 2012
Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356355

Locations
India
AMAI Charitable Trust's ACE Hospital Pune
Pune, Maharashtra, India, 411004
Sponsors and Collaborators
Dr .S.B.PATANKAR
Investigators
Principal Investigator: SURESH B PATANKAR, MS,MCH AMAI CHARITABLE TRUST (AMAI CHARITABLE TRUST'S ACE HOSPITAL PUNE)
  More Information

Publications:
Responsible Party: Dr .S.B.PATANKAR, Amai Charitable Trust,ACE Hospital Pune, Amai Charitable Trust
ClinicalTrials.gov Identifier: NCT01356355     History of Changes
Other Study ID Numbers: ACE/HMP-02 
Study First Received: May 16, 2011
Last Updated: January 4, 2016
Health Authority: India: Indian Council of Medical Research

Keywords provided by Amai Charitable Trust:
Stent discomfort
Herbmed plus
Tolterodine

Additional relevant MeSH terms:
Tolterodine
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on February 11, 2016