Efficacy of Prunus Domestica Extract in BPH

• ClinicalTrials.gov Identifier: NCT02702947
• Recruitment Status: Completed
• First Posted: March 9, 2016
• Last Update Posted: November 2, 2016
• Sponsor: Chemical Resources
• Information provided by (Responsible Party): Chemical Resources

Tracking Information

• First Submitted Date: September 29, 2015
• First Posted Date: March 9, 2016
• Last Update Posted Date: November 2, 2016
• Study Start Date: March 2014
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 3, 2016): Reduction in prostate volume [ Time Frame: 12 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: March 3, 2016): Improvement in urinary flow parameters [ Time Frame: 12 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Prunus Domestica Extract in BPH
• Official Title: EFFICACY EVALUATION OF PRUNUS DOMESTICA EXTRACT ON BENIGN PROSTATE HYPERPLASIA (BPH): An Add on Study

Brief 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 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label)
• Condition: BPH

Intervention

Dietary Supplement: Prunus domestica extract

Prosman 1 capsule twice a day

Other Name: Prosman

Study Arms

Experimental: Prunus Domestica

Prunus domestica extract capsules, 100mg, BD

Intervention: Dietary Supplement: Prunus domestica extract

• Publications *: Roehrborn CG. Benign prostatic hyperplasia: an overview. Rev Urol. 2005;7 Suppl 9(Suppl 9):S3-S14.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 3, 2016): 160
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2016
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 40 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT02702947
• Other Study ID Numbers: CR/ BPH /11/13
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Chemical Resources
• Original Responsible Party: Same as current
• Current Study Sponsor: Chemical Resources
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dr. Satyanarayan sankhwar, M.S., M.Ch.; King George's Medical University, Lucknow, UP, India
• Principal Investigator: Dr. Narsingh Verma, M.D.; King George's Medical University, Lucknow, UP, India

• PRS Account: Chemical Resources
• Verification Date: May 2016