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

May 17, 2011 updated by: Amai Charitable Trust

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Study duration 28 weeks
  2. No. of Scheduled visits 8 visits
  3. 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.

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashatra
      • Pune, Maharashatra, India, 411004
        • Recruiting
        • AMAI Charitable Trust's ACE Hospital Pune
        • Contact:
        • Contact:
        • Principal Investigator:
          • SURESH B PATANKAR, MS.MCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 71 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HERBMED PLUS
Herbal formulation of four constituents i.e.Varuna,Yav,Aghada,Kadali as per ayurvedic literature.
Drug: HERBMED PLUS
500 mg Twice day for 6 month with lunch and dinner.
Other Names:
  • Herbmed plus is ayurvedic formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
In 210 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
In 210 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amai Charitable Trust

Investigators

  • Principal Investigator: SURESH B PATANKAR, MS.Mch., AMAI CHRITABLE TRUST'S ACE HOSPITAL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

May 16, 2011

First Submitted That Met QC Criteria

May 17, 2011

First Posted (Estimate)

May 18, 2011

Study Record Updates

Last Update Posted (Estimate)

May 18, 2011

Last Update Submitted That Met QC Criteria

May 17, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACE/HMP-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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