Efficacy of Prunus Domestica Extract in BPH
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02702947 |
Recruitment Status :
Completed
First Posted : March 9, 2016
Last Update Posted : November 2, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
BPH | Dietary Supplement: Prunus domestica extract | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 160 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | EFFICACY EVALUATION OF PRUNUS DOMESTICA EXTRACT ON BENIGN PROSTATE HYPERPLASIA (BPH): An Add on Study |
Study Start Date : | March 2014 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | September 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: Prunus Domestica
Prunus domestica extract capsules, 100mg, BD
|
Dietary Supplement: Prunus domestica extract
Prosman 1 capsule twice a day
Other Name: Prosman |
- Reduction in prostate volume [ Time Frame: 12 weeks ]
- Improvement in urinary flow parameters [ Time Frame: 12 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702947
India | |
Department of Urology, King George's Medical University, Lucknow, UP, India | |
Lucknow, Uttar Pradesh, India, 226003 |
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 |
Publications:
Responsible Party: | Chemical Resources |
ClinicalTrials.gov Identifier: | NCT02702947 |
Other Study ID Numbers: |
CR/ BPH /11/13 |
First Posted: | March 9, 2016 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | May 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
BPH Prunus Domestica extract |