Clinical Trial: Safety and Efficacy of Herbmed Plus in Patients withRenal Calculi
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
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
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 Summary:
- 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.
Sponsor: Amai Charitable Trust
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Same as current
Information By: Amai Charitable Trust
Dates:
Date Received: May 16, 2011
Date Started: April 2010
Date Completion: December 2011
Last Updated: May 17, 2011
Last Verified: May 2011
