HealthyNCT07145034
Evaluation Of Efficacy And Safety Of Prosman™ (Prunus Domestica Extract) On Prostate Function, Serum Testosterone Levels And Quality Of Life
A study testing Prosman in people with Healthy, run by All India Institute of Medical Sciences, Bhubaneswar.
Trial summary
This study is designed to test the safety and effectiveness of a plant-based supplement called Prosman™ (made from Prunus domestica extract) for men with symptoms of benign prostate hyperplasia (BPH), a common non-cancerous enlargement of the prostate gland that causes urinary problems in older men. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Prosman
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 7 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide voluntarily signed and dated informed consent.
- Be in good health as determined by medical history and routine blood chemistries.
- Age between 40 and 60 yr (inclusive).
- Body Mass Index of 18.5-34.9 (inclusive).
- Body weight of at least 55 kg.
- An IPSS score of 8-19 (inclusive).
Show all 9Show fewer
- Symptoms of benign prostatic hyperplasia (BPH) for at least 6 months prior to screening (e.g. Incomplete emptying: the feeling the bladder is full, even after passing urine; Frequency: the need to pass urine often, about every one to two hours; Intermittency: the need to stop and start several times when passing urine; Urgency: feeling the urgent need to pass urine; Weak stream: a weak urine flow; Straining: trouble starting to pass urine or the need to push or strain to pass urine; Nocturia: the need to wake up at night more than two times to pass urine.
- Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
- The subject is willing and able to comply with the study protocol.
Who cannot join
- Current neurogenic bladder dysfunction.
- Current bladder neck contracture or urethral stricture.
- Current acute or chronic prostatitis or UTI.
- History of prostate cancer.
- Use of any other herbal medication for the treatment of BPH, associated symptoms, and erectile dysfunction within the past month.
- Current hematuria of unknown etiology.
Show all 19Show fewer
- History of radiotherapy.
- History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
- History of diabetes or endocrine disorder.
- History of use of medications or dietary supplements known to confound the study or its endpoints.
- Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
- Current smokers or smoking within the past month.
- History of hyperparathyroidism or an untreated thyroid condition.
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, IBS/IBD, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
- Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's, ulcerative colitis, Lupus, HIV/AIDS, etc.).
- Known sensitivity to any ingredient in the test formulations as listed in the product label.
- Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
- Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is designed to test the safety and effectiveness of a plant-based supplement called Prosman™ (made from Prunus domestica extract) for men with symptoms of benign prostate hyperplasia (BPH), a common non-cancerous enlargement of the prostate gland that causes urinary problems in older men.
Key Points:
Read more
Purpose: The main goal is to see if Prosman™ can improve prostate health, hormone levels, and quality of life in men aged 40 to 60 who have BPH symptoms.
How the Study Works:
38 men will be randomly assigned to take either Prosman™ or a placebo (a dummy pill) every day for 8 weeks.
The study is randomized and controlled, meaning neither the participants nor the researchers know who is getting Prosman™ or the placebo.
Measurements:
Prostate health will be measured using a symptom score.
Blood tests will check hormone levels and other health markers.
Quality of life will also be tracked.
Safety: The study will monitor for any side effects or health problems during the trial.
Why It Matters: Current medications for BPH can have unwanted side effects, so there is interest in plant-based alternatives like Prosman™, which may offer benefits with fewer risks.
The study follows strict ethical guidelines to protect participants' privacy and safety. Data will be kept confidential, and participants can leave the study at any time.
- Conditions
- Healthy
- Being tested
- Prosman, Placebo
- Keywords
- BPH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProsmanDrug
Prosman, the study drug is prepared from the gummy extract (pygeum) from the Indian plum tree Prunus domestica and is available in various dosage forms. Originally, pygeum, was obtained from the African prune tree bark (Prunus africanum) and was used for the treatment of various urinary problems.
PlaceboOther
Placebo matched to the Prosman
| Study group | Role | What they receive |
|---|---|---|
| Prosman | Experimental | ProsmanTM 200 mg capsule to be taken once daily for 8 weeks Receives: Drug: Prosman |
| Placebo | Placebo comparator | Placebo will be taken once daily for 8 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate health (IPSS)
To measure and compare changes in prostate health between and within groups after 8 weeks of therapy with prosmanTM The International Prostate Symptom Score (IPSS) is a questionnaire used to assess the severity of urinary symptoms in men, particularly those related to benign prostatic hyperplasia (BPH). It helps quantify the impact of these symptoms on a man's quality of life and guides treatment decisions.
The IPSS consists of seven questions about urinary symptoms and one question about their impact on quality of life. Each symptom question is scored on a scale of 0 to 5, with higher scores indicating more severe symptoms. The quality of life question is scored from 0 to 6, with higher scores indicating a greater negative impact on quality of life.
The total IPSS score ranges from 0 to 35.
Measured: 8 weeks
Secondary outcomes (12)
Total and free testosterone
To measure and compare changes in serum total and free testosterone between and within groups after 8 weeks of therapy
Measured: 8 weeks
Quality of life (SF-12)
To measure and compare changes in quality of life between and within groups after 8 weeks of therapy
Measured: 8 weeks
Glucose
To measure and compare changes in concentrations of glucose
Measured: 8 weeks
Lipid profile
To measure and compare changes in lipid profile between and within groups.
Measured: 8 weeks
Complete blood count
To measure and compare changes in Total and differential leucocyte count, Red blood cells count and Platelets count between and within groups.
Measured: 8 weeks
Andogen deficiency subjective
To measure and compare changes in subjective measures of androgen deficiency by Androgen Deficiency in Aging Males questionnaire (ADAM) questionnaire.
The ADAM questionnaire, is a screening tool used to assess potential symptoms of low testosterone in men. It's a series of yes/no questions focused on symptoms associated with androgen deficiency, such as decreased libido, fatigue, and erectile dysfunction. A positive response to the questionnaire can indicate a need for further evaluation and potential treatment for low testosterone, also known as hypogonadism between and within groups. The questionnaire typically consists of 10 questions related to symptoms like reduced libido, lack of energy, decreased strength, and erectile dysfunction.
Scoring: A positive ADAM score is typically indicated by answering "yes" to question 1 or 7, or to at least three other questions. This suggests a potential need for further evaluation.
Measured: 8 weeks
Electrolyte chemistry
To measure and compare changes in concentrations of calcium and electrolytes (sodium, potassium, chloride) in mMol/litre
Measured: 8 weeks
Renal function tests -1
To measure and compare changes in concentrations of markers of blood urea nitrogen (BUN) and creatinine in mg/dL.
Measured: 8 weeks
Renal function tests - 2
To measure and compare changes in concentrations of markers of total protein, and albumin IN gram/dL
Measured: 8 weeks
Bilirubin
To measure and compare changes in concentrations of markers of liver function tests (bilirubin) in mg/dL
Measured: 8 weeks
Liver function test
To measure and compare changes in concentrations of markers of liver function tests (alkaline phosphatase (ALP), alanine transaminase (ALT), and aspartate aminotransferase (AST)) in IU/L.
Measured: 8 weeks
Adverse effects
To measure and compare changes in vital signs and adverse events between and within groups.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start7 Sep 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Debasish Hota, All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- Debasish Hota, DM, Principal investigator, AIIMS, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145034
- Sponsor's protocol ID
- T/IM-NF/Pharm/25-26/30
- Status last verified
- Aug 2025
- First submitted
- 8 Jul 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paolone DR. Benign prostatic hyperplasia. Clin Geriatr Med. 2010 May;26(2):223-39. doi: 10.1016/j.cger.2010.02.010.
PubMed 20497842Parsons JK. Modifiable risk factors for benign prostatic hyperplasia and lower urinary tract symptoms: new approaches to old problems. J Urol. 2007 Aug;178(2):395-401. doi: 10.1016/j.juro.2007.03.103. Epub 2007 Jun 11.
PubMed 17561143Thorpe A, Neal D. Benign prostatic hyperplasia. Lancet. 2003 Apr 19;361(9366):1359-67. doi: 10.1016/S0140-6736(03)13073-5.
PubMed 12711484Wilt T, Ishani A, Mac Donald R, Rutks I, Stark G. Pygeum africanum for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2002;1998(1):CD001044. doi: 10.1002/14651858.CD001044.
PubMed 11869585Lees AM, Mok HY, Lees RS, McCluskey MA, Grundy SM. Plant sterols as cholesterol-lowering agents: clinical trials in patients with hypercholesterolemia and studies of sterol balance. Atherosclerosis. 1977 Nov;28(3):325-38. doi: 10.1016/0021-9150(77)90180-0.
PubMed 597345Naiyila X, Li J, Huang Y, Chen B, Zhu M, Li J, Chen Z, Yang L, Ai J, Wei Q, Liu L, Cao D. A Novel Insight into the Immune-Related Interaction of Inflammatory Cytokines in Benign Prostatic Hyperplasia. J Clin Med. 2023 Feb 24;12(5):1821. doi: 10.3390/jcm12051821.
PubMed 36902608
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Efficacy And Safety Of Prosman™ (Prunus Domestica Extract) On Prostate Function, Serum Testosterone Levels And Quality Of Life
- ClinicalTrials.gov ID
- NCT07145034
- Acronym / sponsor ID
- T/IM-NF/Pharm/25-26/30
- Conditions
- Healthy
- Keywords
- BPH
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 7 Sep 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test the safety and effectiveness of a plant-based supplement called Prosman™ (made from Prunus domestica extract) for men with symptoms of benign prostate hyperplasia (BPH), a common non-cancerous enlargement of the prostate gland that causes urinary problems in older men.
Key Points:
Purpose: The main goal is to see if Prosman™ can improve prostate health, hormone levels, and quality of life in men aged 40 to 60 who have BPH symptoms.
How the Study Works:
38 men will be randomly assigned to take either Prosman™ or a placebo (a dummy pill) every day for 8 weeks.
The study is randomized and controlled, meaning neither the participants nor the researchers know who is getting Prosman™ or the placebo.
Measurements:
Prostate health will be measured using a symptom score.
Blood tests will check hormone levels and other health markers.
Quality of life will also be tracked.
Safety: The study will monitor for any side effects or health problems during the trial.
Why It Matters: Current medications for BPH can have unwanted side effects, so there is interest in plant-based alternatives like Prosman™, which may offer benefits with fewer risks.
The study follows strict ethical guidelines to protect participants' privacy and safety. Data will be kept confidential, and participants can leave the study at any time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prosman | Experimental | Drug: ProsmanProsmanTM 200 mg capsule to be taken once daily for 8 weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo will be taken once daily for 8 weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Provide voluntarily signed and dated informed consent.
- Be in good health as determined by medical history and routine blood chemistries.
- Age between 40 and 60 yr (inclusive).
- Body Mass Index of 18.5-34.9 (inclusive).
- Body weight of at least 55 kg.
Key exclusion criteria (19 listed)
- Current neurogenic bladder dysfunction.
- Current bladder neck contracture or urethral stricture.
- Current acute or chronic prostatitis or UTI.
- History of prostate cancer.
- Use of any other herbal medication for the treatment of BPH, associated symptoms, and erectile dysfunction within the past month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProsmanProsman, the study drug is prepared from the gummy extract (pygeum) from the Indian plum tree Prunus domestica and is available in various dosage forms. Originally, pygeum, was obtained from the African prune tree bark (Prunus africanum) and was used for the treatment of various urinary problems. | Drug | Prosman |
| PlaceboPlacebo matched to the Prosman | Other | Placebo |
Primary outcome
Prostate health (IPSS)
Time frame: 8 weeks
To measure and compare changes in prostate health between and within groups after 8 weeks of therapy with prosmanTM The International Prostate Symptom Score (IPSS) is a questionnaire used to assess the severity of urinary symptoms in men, particularly those related to benign prostatic hyperplasia (BPH). It helps quantify the impact of these symptoms on a man's quality of life and guides treatment decisions. The IPSS consists of seven questions about urinary symptoms and one question about their impact on quality of life. Each symptom question is scored on a scale of 0 to 5, with higher scores indicating more severe symptoms. The quality of life question is scored from 0 to 6, with higher scores indicating a greater negative impact on quality of life. The total IPSS score ranges from 0 to 35.
12 secondary outcomes
Total and free testosterone
Time frame: 8 weeks
Quality of life (SF-12)
Time frame: 8 weeks
Glucose
Time frame: 8 weeks
Lipid profile
Time frame: 8 weeks
Complete blood count
Time frame: 8 weeks
Andogen deficiency subjective
Time frame: 8 weeks
Electrolyte chemistry
Time frame: 8 weeks
Renal function tests -1
Time frame: 8 weeks
Renal function tests - 2
Time frame: 8 weeks
Bilirubin
Time frame: 8 weeks
Liver function test
Time frame: 8 weeks
Adverse effects
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Background: PubMed 20497842Paolone DR. Benign prostatic hyperplasia. Clin Geriatr Med. 2010 May;26(2):223-39. doi: 10.1016/j.cger.2010.02.010.
- Background: PubMed 17561143Parsons JK. Modifiable risk factors for benign prostatic hyperplasia and lower urinary tract symptoms: new approaches to old problems. J Urol. 2007 Aug;178(2):395-401. doi: 10.1016/j.juro.2007.03.103. Epub 2007 Jun 11.
- Background: PubMed 12711484Thorpe A, Neal D. Benign prostatic hyperplasia. Lancet. 2003 Apr 19;361(9366):1359-67. doi: 10.1016/S0140-6736(03)13073-5.
- Background: PubMed 11869585Wilt T, Ishani A, Mac Donald R, Rutks I, Stark G. Pygeum africanum for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2002;1998(1):CD001044. doi: 10.1002/14651858.CD001044.
- Background: PubMed 597345Lees AM, Mok HY, Lees RS, McCluskey MA, Grundy SM. Plant sterols as cholesterol-lowering agents: clinical trials in patients with hypercholesterolemia and studies of sterol balance. Atherosclerosis. 1977 Nov;28(3):325-38. doi: 10.1016/0021-9150(77)90180-0.
- Background: PubMed 36902608Naiyila X, Li J, Huang Y, Chen B, Zhu M, Li J, Chen Z, Yang L, Ai J, Wei Q, Liu L, Cao D. A Novel Insight into the Immune-Related Interaction of Inflammatory Cytokines in Benign Prostatic Hyperplasia. J Clin Med. 2023 Feb 24;12(5):1821. doi: 10.3390/jcm12051821.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Debasish Hota, DM principal investigator
AIIMS, Bhubaneswar
Questions about this trial
What is this clinical trial studying?
A study testing Prosman in people with Healthy, run by All India Institute of Medical Sciences, Bhubaneswar.
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 9 inclusion and 19 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: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debasish Hota, DM (9438884190, pharm_debasish@aiimsbhubaneswar.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate health (IPSS) (time frame: 8 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 NCT07145034, which also lists 6 linked publications.
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 5 Sep 2025.