Study of Herbmed Plus in Ureteral Stent Discomfort

• Sponsor: Dr .S.B.PATANKAR (Other)
• Overall Status: Completed
• CT.gov ID: NCT01356355
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Arms: 3
• Duration (Months): 32
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ureteral Stent Discomfort	Drug: Herbmed plus; Drug: Placebo; Drug: Tolterodine	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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 ?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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)

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Dr .S.B.PATANKAR, Amai Charitable Trust,ACE Hospital Pune, Amai Charitable Trust
• ClinicalTrials.gov Identifier: NCT01356355
• Other Study ID Numbers: ACE/HMP-02
• First Posted: May 19, 2011
• Last Update Posted: Jan 5, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Dr .S.B.PATANKAR, Amai Charitable Trust,ACE Hospital Pune, Amai Charitable Trust: Stent discomfort; Herbmed plus; Tolterodine
• Additional relevant MeSH terms: Tolterodine Tartrate

Study Results

No Results Posted as of Jan 5, 2016