RENAL CALCULIPhase 2HerbmedPlusNCT01355341
Safety and Efficacy of Herbmed Plus in Patients withRenal Calculi
A Phase 2 study testing HERBMED PLUS in people with RENAL CALCULI, run by Amai Charitable Trust at 1 site in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 10 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- RENAL CALCULI
- What is being tested?
- HERBMED PLUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2010to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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 .
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
AMAI Charitable Trust's ACE Hospital Pune
Pune, Maharashatra, 411004
SURESH B PATANKAR, MS.MCH., 02025434063 ext. 100, amaitrust@yahoo.co.in
SMITA S BHOYAR, BAMS.CGO, 02025434063,02025434072 ext. 304, drsmitabhoyar@rediffmail.com
About this study
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
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
Read the 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.
- Conditions
- RENAL CALCULI
- Being tested
- HERBMED PLUS
- Keywords
- RENAL CALCULI HERBMED PLUS
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HERBMED PLUSDrug
Also called Herbmed plus is ayurvedic formulation
500 mg Twice day for 6 month with lunch and dinner.
| Study group | Role | What they receive |
|---|---|---|
| HERBMED PLUS | Experimental | Herbal formulation of four constituents i.e.Varuna,Yav,Aghada,Kadali as per ayurvedic literature. Receives: Drug: HERBMED PLUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: In 210 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startApr 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RENAL CALCULIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amai Charitable Trust
- Sponsor type
- University, hospital or other
- Investigators
- SURESH B PATANKAR, MS.Mch., Principal investigator, AMAI CHRITABLE TRUST'S ACE HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355341
- Sponsor's protocol ID
- ACE/HMP-01
- Acronym
- HerbmedPlus
- Status last verified
- May 2011
- First submitted
- 16 May 2011
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01355341
- Acronym / sponsor ID
- HerbmedPlus / ACE/HMP-01
- Conditions
- RENAL CALCULI
- Keywords
- RENAL CALCULI HERBMED PLUS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Amai Charitable TrustUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 18 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HERBMED PLUS | Experimental | Drug: HERBMED PLUSHerbal formulation of four constituents i.e.Varuna,Yav,Aghada,Kadali as per ayurvedic literature. |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HERBMED PLUSAlso: Herbmed plus is ayurvedic formulation500 mg Twice day for 6 month with lunch and dinner. | Drug | HERBMED PLUS |
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
1 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SURESH B PATANKAR, MS.Mch. principal investigator
AMAI CHRITABLE TRUST'S ACE HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HERBMED PLUS in people with RENAL CALCULI, run by Amai Charitable Trust at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PATANKAR B PATANKAR, MS.MCH (25434063 ext. 100, amaitrust@yahoo.co.in; suresh_iou@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2011.