Benign Prostatic HyperplasiaNCT06487871
A Study to Assess the Effect of Fucoidan on Prostate Health in Males With Benign Prostatic Hyperplasia
A study testing Fucoidan extracted from Undaria pinnatifida (UPF) in people with Benign Prostatic Hyperplasia, run by Vedic Lifesciences Pvt. Ltd. at 6 sites in India.
Trial summary
The present study is a randomized, double-blind, placebo-controlled study. Approximately 125 individuals will be screened, and considering a screening failure rate of 20%, at least 100 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Fucoidan extracted from Undaria pinnatifida (UPF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 6 sitesIndia
- Study dates
- 5 Aug 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males aged 45 to 80 years (inclusive of both ages) with a diagnosis of BPH established by a surgeon/nephrologist/urologist within the last 3 months and having any one of the two clinical as well as one of the radio-diagnostic parameters:-
- Clinical parameter: i) History of lower urinary tract symptoms ii) Rectal examination indicating increased prostate size. b) Radio-diagnostic parameter: i) Uroflowmetry (less than 20 ml/sec maximum flow rate [Qmax]) ii) Ultrasound Sonography (USG) - Enlargement of the central gland with a calculated urine volume exceeding 30 mL and increased post-micturition.
- Moderate symptoms with an IPSS Score more than or equal to 8-19.
- No signs of prostate cancer as indicated by 1-3 U/L of Prostatic Acid Phosphatase (PAP) in serum.
- Fasting blood glucose (FBG) less than 125 mg/dL.
- Willing to give voluntary written informed consent and adhere to all the requirements of the study.
- Note: Only biological males will be included. During screening I, if participants are currently on drug/ supplement for BPH, a washout period of 10±2 days will be provided. After this period, the participant will be rescheduled for screening IA.
Who cannot join
- Males with no signs of inflammation as assessed by Erythrocyte Sedimentation Rate (ESR) of more than or equal to 20 mm/hr.
- Males with more than or equal to 3.5 ng/mL of PSA in serum.
- Males diagnosed with prostate cancer.
- Males who have recently started a bladder-training program within the last 30 days.
- Males who have undergone urogenital surgery.
- Males who have had a bladder biopsy and/or cystoscopy and biopsy within the last 30 days.
Show all 16Show fewer
- Males who have had an indwelling catheter or practiced self-catheterization, and/or urethral stricture within the last 30 days.
- Males diagnosed with obstructive renal/urinary tract calculi.
- Males who have been medically diagnosed with chronic persistent local pathology (i.e., interstitial cystitis, prostatitis, etc.)
- Males with chronic inflammatory diseases such as Rheumatoid arthritis (RA), Ulcerative colitis, and Chronic obstructive pulmonary disease (COPD).
- Males receiving or prescribed anticoagulation therapy.
- Males who have been diagnosed with severe renal and/or hepatic insufficiency.
- Males who have been diagnosed with genital anatomical deformities.
- Males with a history of uncontrolled diabetes mellitus, uncontrolled hypertension (SBP/DBP ≥ 140/90 mmHg1 with or without medication), thyroid disorders, spinal cord injury, uncontrolled psychiatric disorder, and/or abnormal secondary sexual characteristics.
- Males who have a history of chronic alcohol (defined as consuming more than 5 drinks on any day or more than 15 drinks/week2) and/or illicit drug abuse.
- Males who have participated in any other clinical study during the last 30 days.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
Jaipur National University of Medical Science and Research Centre Name of
Jaipur, Rajasthan, 7060924809
NKP Salve Institute of Medical Science and Research Centre and Lata Mangeshkar Hospital
Nagpur, Maharashtra, 440025
Rising Medicare Hospital Name of
Pune, Maharashtra, 141014
Pawana Hospital
Pune, Maharashtra, 410506
Bhalerao Clinics
Pune, Maharashtra, 411045
Sarjanam Hospital
Vadodara, Gujarat, 390012
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Fucoidan on Prostate Health in Males With Benign Prostatic Hyperplasia
The present study is a randomized, double-blind, placebo-controlled study. Approximately 125 individuals will be screened, and considering a screening failure rate of 20%, at least 100 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have not less than 40 completed participants after accounting for a dropout/withdrawal rate of 20%. The intervention duration for all the study participants is 90 days.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Fucoidan extracted from Undaria pinnatifida (UPF), Placebo
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fucoidan extracted from Undaria pinnatifida (UPF)Dietary supplement
Two capsules to be taken after breakfast daily, with 200 ml glass of water for 90 days.
PlaceboDietary supplement
Two capsules to be taken after breakfast daily, with 200 ml glass of water for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Fucoidan extracted from Undaria pinnatifida (UPF) | Active comparator | Two capsules to be taken after breakfast daily, with 200 ml glass of water for 90 days. Receives: Dietary Supplement: Fucoidan extracted from Undaria pinnatifida (UPF) |
| Placebo | Placebo comparator | Two capsules to be taken after breakfast daily, with 200 ml glass of water for 90 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.
The International Prostate Symptom Score (IPSS) consists of seven questions that assess both storage and voiding symptoms in participants with Benign Prostatic Hyperplasia (BPH).
Respondents are presented with six response options for each of the seven questions, with scores ranging from 0 to 5 indicating the severity of the respective symptom. The total sum score, ranging from 0 to 35, aids in categorizing the severity of lower urinary tract symptoms (LUTSs): 0 - 7 indicates mild symptoms, 8 - 19 indicates moderate symptoms, and 20 - 35 indicates severe symptoms.
Additionally, the final question of the IPSS addresses Quality of Life (QoL), with responses varying from "delighted" to "terrible" or scores from 0 to 6.
Measured: Day 0
To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.
The International Prostate Symptom Score (IPSS) consists of seven questions that assess both storage and voiding symptoms in participants with Benign Prostatic Hyperplasia (BPH).
Respondents are presented with six response options for each of the seven questions, with scores ranging from 0 to 5 indicating the severity of the respective symptom. The total sum score, ranging from 0 to 35, aids in categorizing the severity of lower urinary tract symptoms (LUTSs): 0 - 7 indicates mild symptoms, 8 - 19 indicates moderate symptoms, and 20 - 35 indicates severe symptoms.
Additionally, the final question of the IPSS addresses Quality of Life (QoL), with responses varying from "delighted" to "terrible" or scores from 0 to 6.
Measured: Day 30
To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.
The International Prostate Symptom Score (IPSS) consists of seven questions that assess both storage and voiding symptoms in participants with Benign Prostatic Hyperplasia (BPH).
Respondents are presented with six response options for each of the seven questions, with scores ranging from 0 to 5 indicating the severity of the respective symptom. The total sum score, ranging from 0 to 35, aids in categorizing the severity of lower urinary tract symptoms (LUTSs): 0 - 7 indicates mild symptoms, 8 - 19 indicates moderate symptoms, and 20 - 35 indicates severe symptoms.
Additionally, the final question of the IPSS addresses Quality of Life (QoL), with responses varying from "delighted" to "terrible" or scores from 0 to 6.
Measured: Day 60
To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.
The International Prostate Symptom Score (IPSS) consists of seven questions that assess both storage and voiding symptoms in participants with Benign Prostatic Hyperplasia (BPH).
Respondents are presented with six response options for each of the seven questions, with scores ranging from 0 to 5 indicating the severity of the respective symptom. The total sum score, ranging from 0 to 35, aids in categorizing the severity of lower urinary tract symptoms (LUTSs): 0 - 7 indicates mild symptoms, 8 - 19 indicates moderate symptoms, and 20 - 35 indicates severe symptoms.
Additionally, the final question of the IPSS addresses Quality of Life (QoL), with responses varying from "delighted" to "terrible" or scores from 0 to 6.
Measured: Day 90
Secondary outcomes (4)
To assess the effect of IP on urinary flow rate as assessed by uroflowmetry.
Uroflowmetry is a simple procedure to assess urine flow rate over time. The machine provides results including maximum flow rate (Qmax), flow time, voided volume, and average flow rate. Typically, urine flow ranges from 10 ml to 21 ml per second. A low flow rate may indicate potential issues such as bladder neck or urethral obstruction or an enlarged prostate. Conversely, a high flow rate might suggest weak muscles surrounding the urethra or urinary incontinence problems.
Measured: Day 0, Day 90
To assess the effect of IP on Post void residual volume (PVR) as assessed by ultrasonography
Post void residual volume (PVR) serves as a diagnostic indicator, representing the urine left in the bladder after voluntary voiding. The PVR measurement, typically obtained through a formal bladder ultrasound examination, precisely quantifies the remaining urine shortly after voiding.
PVR volume of less than 50 mL is deemed sufficient for bladder emptying, while in the elderly, a range between 50 and 100 mL is considered normal. Typically, a PVR volume exceeding 200 mL is regarded as abnormal and may indicate incomplete bladder emptying or bladder outlet obstruction. A PVR volume surpassing 400 mL is considered high.
Measured: Day 0, Day 90
To assess the effect of IP on Prostate-specific antigen (PSA) in serum
PSA, a kallikrein-like serine protease, is primarily produced by prostate epithelial cells to facilitate the liquefaction of ejaculate and support sperm motility. The standard PSA test measures total PSA, encompassing both bound (attached to proteins) and free (unbound) PSA. When both total PSA and free PSA levels are elevated, with a high percentage of free PSA, it typically indicates BPH rather than cancer.
Measured: Day 0, Day 90
To assess the effect of IP on Perceived immune status as assessed by Immune Status Questionnaire (ISQ)
The ISQ is rated on a 5-point Likert scale from 0 to 4.The total sum of ISQ score ranges from 0 to 28, with higher scores indicating poorer immune status.
Measured: Day 0, Day 30, Day 60, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start5 Aug 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487871
- Sponsor's protocol ID
- MN/231202/IP/BPH
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Fucoidan on Prostate Health in Males With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT06487871
- Acronym / sponsor ID
- MN/231202/IP/BPH
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 5 Jul 2024 (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.
The present study is a randomized, double-blind, placebo-controlled study. Approximately 125 individuals will be screened, and considering a screening failure rate of 20%, at least 100 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have not less than 40 completed participants after accounting for a dropout/withdrawal rate of 20%. The intervention duration for all the study participants is 90 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Fucoidan extracted from Undaria pinnatifida (UPF) | Active comparator | Dietary Supplement: Fucoidan extracted from Undaria pinnatifida (UPF)Two capsules to be taken after breakfast daily, with 200 ml glass of water for 90 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTwo capsules to be taken after breakfast daily, with 200 ml glass of water for 90 days. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males aged 45 to 80 years (inclusive of both ages) with a diagnosis of BPH established by a surgeon/nephrologist/urologist within the last 3 months and having any one of the two clinical as well as one of the radio-diagnostic parameters:-
- Moderate symptoms with an IPSS Score more than or equal to 8-19.
- No signs of prostate cancer as indicated by 1-3 U/L of Prostatic Acid Phosphatase (PAP) in serum.
- Fasting blood glucose (FBG) less than 125 mg/dL.
- Willing to give voluntary written informed consent and adhere to all the requirements of the study.
Key exclusion criteria (16 listed)
- Males with no signs of inflammation as assessed by Erythrocyte Sedimentation Rate (ESR) of more than or equal to 20 mm/hr.
- Males with more than or equal to 3.5 ng/mL of PSA in serum.
- Males diagnosed with prostate cancer.
- Males who have recently started a bladder-training program within the last 30 days.
- Males who have undergone urogenital surgery.
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 |
|---|---|---|
| Fucoidan extracted from Undaria pinnatifida (UPF)Two capsules to be taken after breakfast daily, with 200 ml glass of water for 90 days. | Dietary supplement | Fucoidan extracted from Undaria pinnatifida (UPF) |
| PlaceboTwo capsules to be taken after breakfast daily, with 200 ml glass of water for 90 days. | Dietary supplement | Placebo |
Primary outcome
To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.
Time frame: Day 0
The International Prostate Symptom Score (IPSS) consists of seven questions that assess both storage and voiding symptoms in participants with Benign Prostatic Hyperplasia (BPH). Respondents are presented with six response options for each of the seven questions, with scores ranging from 0 to 5 indicating the severity of the respective symptom. The total sum score, ranging from 0 to 35, aids in categorizing the severity of lower urinary tract symptoms (LUTSs): 0 - 7 indicates mild symptoms, 8 - 19 indicates moderate symptoms, and 20 - 35 indicates severe symptoms. Additionally, the final question of the IPSS addresses Quality of Life (QoL), with responses varying from "delighted" to "terrible" or scores from 0 to 6.
To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.
Time frame: Day 30
The International Prostate Symptom Score (IPSS) consists of seven questions that assess both storage and voiding symptoms in participants with Benign Prostatic Hyperplasia (BPH). Respondents are presented with six response options for each of the seven questions, with scores ranging from 0 to 5 indicating the severity of the respective symptom. The total sum score, ranging from 0 to 35, aids in categorizing the severity of lower urinary tract symptoms (LUTSs): 0 - 7 indicates mild symptoms, 8 - 19 indicates moderate symptoms, and 20 - 35 indicates severe symptoms. Additionally, the final question of the IPSS addresses Quality of Life (QoL), with responses varying from "delighted" to "terrible" or scores from 0 to 6.
To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.
Time frame: Day 60
The International Prostate Symptom Score (IPSS) consists of seven questions that assess both storage and voiding symptoms in participants with Benign Prostatic Hyperplasia (BPH). Respondents are presented with six response options for each of the seven questions, with scores ranging from 0 to 5 indicating the severity of the respective symptom. The total sum score, ranging from 0 to 35, aids in categorizing the severity of lower urinary tract symptoms (LUTSs): 0 - 7 indicates mild symptoms, 8 - 19 indicates moderate symptoms, and 20 - 35 indicates severe symptoms. Additionally, the final question of the IPSS addresses Quality of Life (QoL), with responses varying from "delighted" to "terrible" or scores from 0 to 6.
To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.
Time frame: Day 90
The International Prostate Symptom Score (IPSS) consists of seven questions that assess both storage and voiding symptoms in participants with Benign Prostatic Hyperplasia (BPH). Respondents are presented with six response options for each of the seven questions, with scores ranging from 0 to 5 indicating the severity of the respective symptom. The total sum score, ranging from 0 to 35, aids in categorizing the severity of lower urinary tract symptoms (LUTSs): 0 - 7 indicates mild symptoms, 8 - 19 indicates moderate symptoms, and 20 - 35 indicates severe symptoms. Additionally, the final question of the IPSS addresses Quality of Life (QoL), with responses varying from "delighted" to "terrible" or scores from 0 to 6.
4 secondary outcomes
To assess the effect of IP on urinary flow rate as assessed by uroflowmetry.
Time frame: Day 0, Day 90
To assess the effect of IP on Post void residual volume (PVR) as assessed by ultrasonography
Time frame: Day 0, Day 90
To assess the effect of IP on Prostate-specific antigen (PSA) in serum
Time frame: Day 0, Day 90
To assess the effect of IP on Perceived immune status as assessed by Immune Status Questionnaire (ISQ)
Time frame: Day 0, Day 30, Day 60, Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fucoidan extracted from Undaria pinnatifida (UPF) in people with Benign Prostatic Hyperplasia, run by Vedic Lifesciences Pvt. Ltd. at 6 sites in India.
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 7 inclusion and 16 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: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo. (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2025.