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Safety and Efficacy of Herbmed Plus in Patients withRenal Calculi (HerbmedPlus)

Primary Purpose

RENAL CALCULI

Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
HERBMED PLUS
Sponsored by
Amai Charitable Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RENAL CALCULI focused on measuring RENAL CALCULI HERBMED PLUS

Eligibility Criteria

10 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 10-75 years (Both inclusive)
  • Patients with Renal calculi, diagnosis confirmed by plain X-ray KUB &/or ultrasound KUB/CT scan Abdomen
  • Size of the calculi ranging from 04 mm -09 mm
  • Able and willing to give written informed consent and comply with the requirements of the study protocol
  • 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
  • Patients will to cooperate & give consent for the trial& comes for regular follow up.

Exclusion Criteria:

  • Patients having acute condition of renal calculi.
  • Any systemic disease requiring other medications of surgery for calculus condition.
  • Complicated cases of Renal Calculi requiring surgical condition.
  • Chronic or current infectious disease such as but not limited to chronic renal infection including active urinary tract infection.Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction
  • Any other urogenital disorders.
  • Liver dysfunction, defined as total bilirubin more then 1.5 the upper limit of Normal, aspartate aminotransferase more then 2.5 upper limit of Normal, or alanine aminotransferase more then 2.5 upper limit of Normal,
  • Kidney disease, including serum creatinine level more then 1.5 upper limit of Normal,
  • Subjects on herbal supplements for stone disease (plant extracts preparations or herbal medicines etc.) within previous 3 months.
  • Participated in another clinical drug trial within 3 months before recruitment.
  • Pregnancy or breast feeding
  • Evidence of significant uncontrolled concomitant disease which in the Investigator's opinion would preclude patient participation
  • Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline
  • Patients with psychiatric illness or other condition that would limit compliance with study requirements
  • Patients receiving or has received any investigational drug within 30 days before receiving the first dose of study medication
  • Subjects who refuse to sign the informed consent document .

Sites / Locations

  • AMAI Charitable Trust's ACE Hospital PuneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HERBMED PLUS

Arm Description

Herbal formulation of four constituents i.e.Varuna,Yav,Aghada,Kadali as per ayurvedic literature.

Outcomes

Primary Outcome Measures

To evaluate the efficacy of "Herbmed plus"in patients with urinary calculi by assessing the reduction in the stone size & surface area/ or the expulsion of stone

Secondary Outcome Measures

Reduction in the size of stone Reduction in the density of the stone Painless expulsion of the stone/fragments Reduction in pain Consumption of Analgesics

Full Information

First Posted
May 16, 2011
Last Updated
May 17, 2011
Sponsor
Amai Charitable Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01355341
Brief Title
Safety and Efficacy of Herbmed Plus in Patients withRenal Calculi
Acronym
HerbmedPlus
Official Title
A Phase II, 28 Week, Randomized, Double- Blind, Placebo- Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of 'Herbmed Plus' an Ayurvedic Formulation in Patients With Renal Calculi
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Amai Charitable Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
More specifically, the present invention relates to a 'Herbal Preparation' that is useful for Treatment of Renal calculi Reduction in the stone size & surface area The expulsion of stone Decreased need of Analgesic(Antiinflammatory Effect) Stops the recurrence and reformation of renal
Detailed Description
Study duration 28 weeks No. of Scheduled visits 8 visits Study product Dose, Group one-:1capsule (of 500 mg) orally twice a day with meals for 24 weeks. Group two-:placebo1capsule (of 500 mg) orally twice a day with meals for 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RENAL CALCULI
Keywords
RENAL CALCULI HERBMED PLUS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HERBMED PLUS
Arm Type
Experimental
Arm Description
Herbal formulation of four constituents i.e.Varuna,Yav,Aghada,Kadali as per ayurvedic literature.
Intervention Type
Drug
Intervention Name(s)
HERBMED PLUS
Other Intervention Name(s)
Herbmed plus is ayurvedic formulation
Intervention Description
500 mg Twice day for 6 month with lunch and dinner.
Primary Outcome Measure Information:
Title
To evaluate the efficacy of "Herbmed plus"in patients with urinary calculi by assessing the reduction in the stone size & surface area/ or the expulsion of stone
Time Frame
In 210 days
Secondary Outcome Measure Information:
Title
Reduction in the size of stone Reduction in the density of the stone Painless expulsion of the stone/fragments Reduction in pain Consumption of Analgesics
Time Frame
In 210 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 10-75 years (Both inclusive) Patients with Renal calculi, diagnosis confirmed by plain X-ray KUB &/or ultrasound KUB/CT scan Abdomen Size of the calculi ranging from 04 mm -09 mm Able and willing to give written informed consent and comply with the requirements of the study protocol 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 Patients will to cooperate & give consent for the trial& comes for regular follow up. Exclusion Criteria: Patients having acute condition of renal calculi. Any systemic disease requiring other medications of surgery for calculus condition. Complicated cases of Renal Calculi requiring surgical condition. Chronic or current infectious disease such as but not limited to chronic renal infection including active urinary tract infection.Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction Any other urogenital disorders. Liver dysfunction, defined as total bilirubin more then 1.5 the upper limit of Normal, aspartate aminotransferase more then 2.5 upper limit of Normal, or alanine aminotransferase more then 2.5 upper limit of Normal, Kidney disease, including serum creatinine level more then 1.5 upper limit of Normal, Subjects on herbal supplements for stone disease (plant extracts preparations or herbal medicines etc.) within previous 3 months. Participated in another clinical drug trial within 3 months before recruitment. Pregnancy or breast feeding Evidence of significant uncontrolled concomitant disease which in the Investigator's opinion would preclude patient participation Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline Patients with psychiatric illness or other condition that would limit compliance with study requirements Patients receiving or has received any investigational drug within 30 days before receiving the first dose of study medication Subjects who refuse to sign the informed consent document .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PATANKAR B PATANKAR, MS.MCH
Phone
25434063
Ext
100
Email
amaitrust@yahoo.co.in; suresh_iou@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
SMITA S BHOYAR, BAMS CGO
Phone
25434072
Ext
304
Email
drsmitabhoyar@rediffmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SURESH B PATANKAR, MS.Mch.
Organizational Affiliation
AMAI CHRITABLE TRUST'S ACE HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
AMAI Charitable Trust's ACE Hospital Pune
City
Pune
State/Province
Maharashatra
ZIP/Postal Code
411004
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SURESH B PATANKAR, MS.MCH.
Phone
02025434063
Ext
100
Email
amaitrust@yahoo.co.in
First Name & Middle Initial & Last Name & Degree
SMITA S BHOYAR, BAMS.CGO
Phone
02025434063,02025434072
Ext
304
Email
drsmitabhoyar@rediffmail.com
First Name & Middle Initial & Last Name & Degree
SURESH B PATANKAR, MS.MCH

12. IPD Sharing Statement

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Safety and Efficacy of Herbmed Plus in Patients withRenal Calculi

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