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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Amai Charitable Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Amai Charitable Trust
ClinicalTrials.gov Identifier:
NCT01355341
First received: May 16, 2011
Last updated: May 17, 2011
Last verified: May 2011
  Purpose

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

Condition Intervention Phase
RENAL CALCULI
Drug: HERBMED PLUS
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: 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

Further study details as provided by Amai Charitable Trust:

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 [ Time Frame: In 210 days ] [ Designated as safety issue: Yes ]

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 [ Time Frame: In 210 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 84
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Herbmed plus is ayurvedic formulation

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.
  Eligibility

Ages Eligible for Study:   10 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 .
  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: NCT01355341

Contacts
Contact: PATANKAR B PATANKAR, MS.MCH 25434063 ext 100 amaitrust@yahoo.co.in; suresh_iou@yahoo.com
Contact: SMITA S BHOYAR, BAMS CGO 25434072 ext 304 drsmitabhoyar@rediffmail.com

Locations
India
AMAI Charitable Trust's ACE Hospital Pune Recruiting
Pune, Maharashatra, India, 411004
Contact: SURESH B PATANKAR, MS.MCH.    02025434063 ext 100    amaitrust@yahoo.co.in   
Contact: SMITA S BHOYAR, BAMS.CGO    02025434063,02025434072 ext 304    drsmitabhoyar@rediffmail.com   
Principal Investigator: SURESH B PATANKAR, MS.MCH         
Sponsors and Collaborators
Amai Charitable Trust
Investigators
Principal Investigator: SURESH B PATANKAR, MS.Mch. AMAI CHRITABLE TRUST'S ACE HOSPITAL
  More Information

No publications provided

Responsible Party: AMAI CHARITABLE TRUST'S ACE HOSPITAL PUNE, AMAI CHARITABLE TRUST
ClinicalTrials.gov Identifier: NCT01355341     History of Changes
Other Study ID Numbers: ACE/HMP-01
Study First Received: May 16, 2011
Last Updated: May 17, 2011
Health Authority: India: Indian Council of Medical Research

Keywords provided by Amai Charitable Trust:
RENAL CALCULI HERBMED PLUS

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Pathological Conditions, Anatomical
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi

ClinicalTrials.gov processed this record on July 24, 2014