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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.
Show all 10Show fewer
  • 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

Other trials in India

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 groups in NCT02702947
Study groupRoleWhat they receive
Prunus DomesticaExperimentalPrunus 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.

  1. Reduction in prostate volume

    Measured: 12 weeks

Secondary outcomes (1)
  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.

  1. First posted9 Mar 2016 (estimated)
  2. Study startMar 2014
  3. Primary completionMay 2016
  4. Study completionSep 2016

Resources

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)
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

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.

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