Evaluation Of Efficacy And Safety Of Prosman™ (Prunus Dom... | NCT07145034

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prosman	Experimental	ProsmanTM 200 mg capsule to be taken once daily for 8 weeks	Drug: Prosman
Placebo	Placebo Comparator	Placebo will be taken once daily for 8 weeks	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prosman	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Total and free testosterone	To measure and compare changes in serum total and free testosterone between and within groups after 8 weeks of therapy	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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).
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.

Exclusion Criteria:

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.
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.

Name	Role	Phone	Extension	Email
Debasish Hota, DM	Contact	9438884190		pharm_debasish@aiimsbhubaneswar.edu.in
Rituparna Maiti, MD	Contact	9438884191		pharm_rituparna@aiimsbhubaneswar.edu.in

PubMed Identifier	Type	Citation	Retractions
20497842	Background	Paolone DR. Benign prostatic hyperplasia. Clin Geriatr Med. 2010 May;26(2):223-39. doi: 10.1016/j.cger.2010.02.010.
17561143	Background	Parsons 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.