BPHPhase 4NCT02702947
Efficacy of Prunus Domestica Extract in BPH
A Phase 4 study testing Prunus domestica extract in people with BPH, run by Chemical Resources at 1 site in India.
Trial summary
Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate Prunus domestica bark contains three groups of active constituents: phytosterols (including beta-sitosterol), pentacyclic triterpenoids (including ursolic and oleaic acids) and ferulic esters of long-chain fatty alcohols (including… Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- BPH
- What is being tested?
- Prunus domestica extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2014to Sep 2016
- Phase
- Phase 4
- 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 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 40 and 65 years
- Only Male included
- Has suffered from symptoms of BPH for at least the 6 months before Screening.
- Has a prostate volume ≥ 20 mL and ≤ 70 mL as assessed by ultrasound
- Has an IPSS ≥ 8 at Screening and Baseline
- Patients willing to give informed consent in writing
Who cannot join
- Neurogenic bladder dysfunction
- Has bladder neck contracture or urethral stricture
- Has acute or chronic prostatitis or urinary tract infection
- Has a history of, prostate cancer or carcinoma of the prostate suspected on digital rectal exam.
- Participation in any other clinical trial with in the last 30 days
- Has resting systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg or < 60 mmHg at Screening.
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- Urine flow< 5mls/sec.
- Use of any other herbal medications for treatment of BPH, associated symptoms and Erectile Dysfunction in past 1 month.
- Has hematuria of unknown etiology.
- Previous radiotherapy
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Urology, King George's Medical University, Lucknow, UP, India
Lucknow, Uttar Pradesh, 226003
About this study
Official title: EFFICACY EVALUATION OF PRUNUS DOMESTICA EXTRACT ON BENIGN PROSTATE HYPERPLASIA (BPH): An Add on Study
Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate Prunus domestica bark contains three groups of active constituents: phytosterols (including beta-sitosterol), pentacyclic triterpenoids (including ursolic and oleaic acids) and ferulic esters of long-chain fatty alcohols (including ferulic esters of docosanol and tetracosanol).
The phytosterols, particularly beta-sitosterol, are found in numerous plants and are anti-inflammatory, inhibiting the synthesis of prostaglandins. Beta-sitosterol has been shown to be useful in cases of BPH by helping to reduce the normally elevated levels of prostaglandins in these patients.
Read the detailed description
Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate. Symptoms related to BPH are one of the most common problems in older men. Histological evidence of BPH is found in more than is approximately 10% for men in their 30s, 20% for men in their 40s, reaches 50% to 60% for men in their 60s, and is 80% to 90% for men in their 70s and 80s. The majority of men over the age of 60 are considered to have urinary symptoms attributable to BPH.
The proliferative disorder resulting in BPH affects both the stromal and the epithelial portions of the prostate. The enlarging prostate results in the progressive occlusion of the proximal urethra and can result in both obstructive and irritative urinary tract symptoms.
The preferred medical treatment for many men with symptomatic benign prostatic hyperplasia is either an alpha-adrenergic-receptor antagonist (alpha-blocker), which reduces smooth-muscle tone in the prostate, and bladder neck, or a 5α-reductase inhibitor, which reduces prostate volume by inducing epithelial atrophy. These drugs have side effects including:-dizziness, fatigue, hypotension, headache, insomnia, gynecomastia, and retrograde ejaculation.
The use of plants and herbs for medicinal purposes (phytotherapy) including treatment of BPH symptoms has been growing steadily in most countries. Usage of plant extracts is common in many countries of the world and is increasing in the United States. Phytotherapeutic agents represent nearly half of the medications dispensed for BPH in Italy, compared with 5% for alpha blockers and 5% for 5-alpha reductase inhibitors. In Germany and Austria, phytotherapy is the first-line treatment for mild to moderate urinary obstructive symptoms and represents > 90% of all drugs prescribed for the treatment of BPH. In the United States their use has also markedly increased, they are readily available as nonprescription dietary supplements and are often recommended in "natural health food stores or books" for self treatment of BPH symptoms.
Prunus domestica, or European plum, is a small deciduous tree in the Rosaceae (rose) family that is an ancient domesticated species, known only in cultivation. It is now cultivated in temperate areas worldwide for its fruit.
Mechanism of action The bark contains three groups of active constituents: phytosterols (including beta-sitosterol), pentacyclic triterpenoids (including ursolic and oleaic acids) and ferulic esters of long-chain fatty alcohols (including ferulic esters of docosanol and tetracosanol).
The phytosterols, particularly beta-sitosterol, are found in numerous plants and are anti-inflammatory, inhibiting the synthesis of prostaglandins. Beta-sitosterol has been shown to be useful in cases of BPH by helping to reduce the normally elevated levels of prostaglandins in these patients. The elimination of the excess blood and vasal congestion helps reduce the size of prostate adenomas. The pentacyclic triterpenoids also help inhibit inflammation by blocking enzymatic activity. They are effective anti-edema agents and also help increase the integrity of small veins and capillaries. The third active group, the ferulic esters of long-chain fatty acids, act by inhibiting the absorption and metabolism of cholesterol. BPH and other cases of enlarged prostates are characterized by containing abnormally high levels of cholesterol. Plant efficacy was determined by measuring the effects of the herb on numerous parameters, including dysuria, nycturia, frequent urination, abdominal heaviness, residual urine, voiding volume, prostate volume, and peak flow. Consumption of P.Domestica resulted in significant amelioration of symptoms, reduction in prostate size, and clearance of bladder neck urethral obstruction.
Different studies suggest that these phytochemicals appear to work synergistically to improve the symptoms of BPH. However, the most bioactive phytochemicals in pygeum are the phytosterols. Therefore, these components of pygeum extract are believed to exert the most important therapeutic effect in the treatment of BPH.
- Conditions
- BPH
- Being tested
- Prunus domestica extract
- Keywords
- BPH, Prunus Domestica extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prunus domestica extractDietary supplement
Also called Prosman
Prosman 1 capsule twice a day
| Study group | Role | What they receive |
|---|---|---|
| Prunus Domestica | Experimental | Prunus domestica extract capsules, 100mg, BD Receives: Dietary Supplement: Prunus domestica extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in prostate volume
Measured: 12 weeks
Secondary outcomes (1)
Improvement in urinary flow parameters
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startMar 2014
- Primary completionMay 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BPHStudies 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 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chemical Resources
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Satyanarayan sankhwar, M.S., M.Ch., Principal investigator, King George's Medical University, Lucknow, UP, IndiaDr. Narsingh Verma, M.D., Principal investigator, King George's Medical University, Lucknow, UP, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702947
- Sponsor's protocol ID
- CR/ BPH /11/13
- Status last verified
- May 2016
- First submitted
- 29 Sep 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Roehrborn CG. Benign prostatic hyperplasia: an overview. Rev Urol. 2005;7 Suppl 9(Suppl 9):S3-S14.
PubMed 16985902
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY EVALUATION OF PRUNUS DOMESTICA EXTRACT ON BENIGN PROSTATE HYPERPLASIA (BPH): An Add on Study
- ClinicalTrials.gov ID
- NCT02702947
- Acronym / sponsor ID
- CR/ BPH /11/13
- Conditions
- BPH
- Keywords
- BPH, Prunus Domestica extract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Chemical ResourcesIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Mar 2016 (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.
Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate Prunus domestica bark contains three groups of active constituents: phytosterols (including beta-sitosterol), pentacyclic triterpenoids (including ursolic and oleaic acids) and ferulic esters of long-chain fatty alcohols (including ferulic esters of docosanol and tetracosanol).
The phytosterols, particularly beta-sitosterol, are found in numerous plants and are anti-inflammatory, inhibiting the synthesis of prostaglandins. Beta-sitosterol has been shown to be useful in cases of BPH by helping to reduce the normally elevated levels of prostaglandins in these patients.
Detailed description
Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate. Symptoms related to BPH are one of the most common problems in older men. Histological evidence of BPH is found in more than is approximately 10% for men in their 30s, 20% for men in their 40s, reaches 50% to 60% for men in their 60s, and is 80% to 90% for men in their 70s and 80s. The majority of men over the age of 60 are considered to have urinary symptoms attributable to BPH.
The proliferative disorder resulting in BPH affects both the stromal and the epithelial portions of the prostate. The enlarging prostate results in the progressive occlusion of the proximal urethra and can result in both obstructive and irritative urinary tract symptoms.
The preferred medical treatment for many men with symptomatic benign prostatic hyperplasia is either an alpha-adrenergic-receptor antagonist (alpha-blocker), which reduces smooth-muscle tone in the prostate, and bladder neck, or a 5α-reductase inhibitor, which reduces prostate volume by inducing epithelial atrophy. These drugs have side effects including:-dizziness, fatigue, hypotension, headache, insomnia, gynecomastia, and retrograde ejaculation.
The use of plants and herbs for medicinal purposes (phytotherapy) including treatment of BPH symptoms has been growing steadily in most countries. Usage of plant extracts is common in many countries of the world and is increasing in the United States. Phytotherapeutic agents represent nearly half of the medications dispensed for BPH in Italy, compared with 5% for alpha blockers and 5% for 5-alpha reductase inhibitors. In Germany and Austria, phytotherapy is the first-line treatment for mild to moderate urinary obstructive symptoms and represents > 90% of all drugs prescribed for the treatment of BPH. In the United States their use has also markedly increased, they are readily available as nonprescription dietary supplements and are often recommended in "natural health food stores or books" for self treatment of BPH symptoms.
Prunus domestica, or European plum, is a small deciduous tree in the Rosaceae (rose) family that is an ancient domesticated species, known only in cultivation. It is now cultivated in temperate areas worldwide for its fruit.
Mechanism of action The bark contains three groups of active constituents: phytosterols (including beta-sitosterol), pentacyclic triterpenoids (including ursolic and oleaic acids) and ferulic esters of long-chain fatty alcohols (including ferulic esters of docosanol and tetracosanol).
The phytosterols, particularly beta-sitosterol, are found in numerous plants and are anti-inflammatory, inhibiting the synthesis of prostaglandins. Beta-sitosterol has been shown to be useful in cases of BPH by helping to reduce the normally elevated levels of prostaglandins in these patients. The elimination of the excess blood and vasal congestion helps reduce the size of prostate adenomas. The pentacyclic triterpenoids also help inhibit inflammation by blocking enzymatic activity. They are effective anti-edema agents and also help increase the integrity of small veins and capillaries. The third active group, the ferulic esters of long-chain fatty acids, act by inhibiting the absorption and metabolism of cholesterol. BPH and other cases of enlarged prostates are characterized by containing abnormally high levels of cholesterol. Plant efficacy was determined by measuring the effects of the herb on numerous parameters, including dysuria, nycturia, frequent urination, abdominal heaviness, residual urine, voiding volume, prostate volume, and peak flow. Consumption of P.Domestica resulted in significant amelioration of symptoms, reduction in prostate size, and clearance of bladder neck urethral obstruction.
Different studies suggest that these phytochemicals appear to work synergistically to improve the symptoms of BPH. However, the most bioactive phytochemicals in pygeum are the phytosterols. Therefore, these components of pygeum extract are believed to exert the most important therapeutic effect in the treatment of BPH.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prunus Domestica | Experimental | Dietary Supplement: Prunus domestica extractPrunus domestica extract capsules, 100mg, BD |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 40 and 65 years
- Only Male included
- Has suffered from symptoms of BPH for at least the 6 months before Screening.
- Has a prostate volume ≥ 20 mL and ≤ 70 mL as assessed by ultrasound
- Has an IPSS ≥ 8 at Screening and Baseline
Key exclusion criteria (10 listed)
- Neurogenic bladder dysfunction
- Has bladder neck contracture or urethral stricture
- Has acute or chronic prostatitis or urinary tract infection
- Has a history of, prostate cancer or carcinoma of the prostate suspected on digital rectal exam.
- Participation in any other clinical trial with in the last 30 days
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 |
|---|---|---|
| Prunus domestica extractAlso: ProsmanProsman 1 capsule twice a day | Dietary supplement | Prunus Domestica |
Primary outcome
Reduction in prostate volume
Time frame: 12 weeks
1 secondary outcome
Improvement in urinary flow parameters
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Background: PubMed 16985902Roehrborn CG. Benign prostatic hyperplasia: an overview. Rev Urol. 2005;7 Suppl 9(Suppl 9):S3-S14.
- Phytotherapeutic agents in the treatment of benign prostatic hyperplasiaLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for BPH
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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.
Dr. Satyanarayan sankhwar, M.S., M.Ch. principal investigator
King George's Medical University, Lucknow, UP, India
Dr. Narsingh Verma, M.D. principal investigator
King George's Medical University, Lucknow, UP, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prunus domestica extract in people with BPH, run by Chemical Resources 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 10 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: finished, as of the sponsor's last update on 2 Nov 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in prostate volume (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02702947, which also lists 1 linked publication.
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 2 Nov 2016.