Efficacy of Prunus Domestica Extract in BPH

NCT02702947 | Completed Phase 4

• 1 other identifier: CR/ BPH /11/13
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

BPH

Keywords

BPH; Prunus Domestica extract

Outcome Measures

Primary Outcomes (1)

• Reduction in prostate volume

  12 weeks

Secondary Outcomes (1)

• Improvement in urinary flow parameters

  12 weeks

Study Arms (1)

Prunus Domestica

EXPERIMENTAL

Prunus domestica extract capsules, 100mg, BD

Dietary Supplement: Prunus domestica extract

Interventions

Prunus domestica extract DIETARY_SUPPLEMENT

Prosman 1 capsule twice a day

Also known as: Prosman

Prunus Domestica

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chemical Resources: lead

Study Sites (1)

Department of Urology, King George's Medical University, Lucknow, UP, India

Lucknow, Uttar Pradesh, 226003, India

Location

Related Publications (1)

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

  PMID: 16985902 BACKGROUND

Related Links

• Phytotherapeutic agents in the treatment of benign prostatic hyperplasia

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: March 9, 2016
• Study Start: March 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 2, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)