Safety and Efficacy of Herbmed Plus in Patients withRenal Calculi

NCT01355341 | Unknown Phase 2

• 1 other identifier: ACE/HMP-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

RENAL CALCULI

Keywords

RENAL CALCULI HERBMED PLUS

Outcome Measures

Primary Outcomes (1)

• 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

  In 210 days

Secondary Outcomes (1)

• 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

  In 210 days

Study Arms (1)

HERBMED PLUS

EXPERIMENTAL

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

Drug: HERBMED PLUS

Interventions

HERBMED PLUS DRUG

500 mg Twice day for 6 month with lunch and dinner.

Also known as: Herbmed plus is ayurvedic formulation

HERBMED PLUS

Eligibility Criteria

• Age: 10 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Amai Charitable Trust: lead

Study Sites (1)

AMAI Charitable Trust's ACE Hospital Pune

Pune, Maharashatra, 411004, India

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• SURESH B PATANKAR, MS.Mch.

  AMAI CHRITABLE TRUST'S ACE HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PATANKAR B PATANKAR, MS.MCH

CONTACT

25434063; amaitrust@yahoo.co.in; suresh_iou@yahoo.com

SMITA S BHOYAR, BAMS CGO

CONTACT

25434072; drsmitabhoyar@rediffmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 18, 2011
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 18, 2011

Record last verified: 2011-05

Locations

IN (1)