Efficacy of Prunus Domestica Extract in BPH
Efficacy of Prunus Domestica Extract in BPH
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.
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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.

 -  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