BPH (Benign Prostatic Hyperplasia)Phase 1ALOE-DUTA-BPHNCT07065682
Effetivity of Dutasteride and Aloe Vera Extract Combination on Angiogenesis and Obstruction on Benign Prostatic Hyperplasia
A Phase 1 study testing Aloevera + dutasteride and Dutasteride (0.5mg) in people with BPH (Benign Prostatic Hyperplasia), run by Universitas Diponegoro at 1 site in Indonesia.
Trial summary
This study is a double blinded RCT with pre-post test design on the effect of combination of dutasteride and aloe vera, compared to dutasteride only, on uroflowmetry results, prostate volume, and VEGF serum level among patients with benign prostate hyperplasia. The treatment was given for 12 weeks Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia)
- What is being tested?
- Aloevera + dutasteride and Dutasteride (0.5mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2023to 1 Dec 2027
- Phase
- Phase 1
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with BPH clinically or radiologically (prostate volume > 30 gram, Qmax <15 mL/s)
- Willing to participate to the study
Who cannot join
- Clinically or radiologically suspected of having prostatic cancer
- Previous prostatic surgery
- Patients with urinary retention
- Patients with BPH complications: urinary tract infections, urolithiasis, or hydroneprhosis
- Previously consumed alpha blocker or 5ARI in the last 6 months
- Have consumed aloe vera extract routinely
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Achmad Rizky Herda Pratama dr. Achmad Rizky Herda Pratama, Sp.U, S.H, Urologist contact
Indonesia1 site, 1 recruiting
- Recruiting
RSUD Karawang
Karawang, West Java
Achmad Rizky Herda Pratama dr. Achmad Rizky Herda Pratama, Sp.U, S.H, Urologist, +6282184801976, herdapratama@gmail.com
Achmad Rizky Herda Pratama dr. Achmad Rizky Herda Pratama, Sp.U, S.H, Urologist
About this study
This study is a double blinded RCT with pre-post test design on the effect of combination of dutasteride and aloe vera, compared to dutasteride only, on uroflowmetry results, prostate volume, and VEGF serum level among patients with benign prostate hyperplasia. The treatment was given for 12 weeks
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Being tested
- Aloevera + dutasteride, Dutasteride (0.5mg)
- Keywords
- Aloe Vera, Benign prostate hyperplasia, VEGF, Prostate, dutasteride, uroflowmetry, prostatic hyperplasia
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aloevera + dutasterideDrug
Dutasteride 0,5 mg/day + Aloe Vera Extract 380 mg/day
Dutasteride (0.5mg)Drug
Control
| Study group | Role | What they receive |
|---|---|---|
| Dutasteride 0,5 mg/day + Aloe Vera Extract 380 mg/day | Experimental | Not described Receives: Drug: Aloevera + dutasteride |
| Dutasteride | Active comparator | Control Receives: Drug: Dutasteride (0.5mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uroflowmetry result
Qmax of Uroflowmetry result
Measured: 12 weeks
Secondary outcomes (2)
Prostatic volume
Measured by transabdominal ultrasonography
Measured: 12 weeks
VEGF
serum VEGF level
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Jul 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Diponegoro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Achmad Rizky Herda Pratama, Universitas Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065682
- Sponsor's protocol ID
- 22010119510006
- Acronym
- ALOE-DUTA-BPH
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nugroho E, Azhar A, Gunadi E. Relationship between Prostate Volume and International Prostate Symptom Score (IPSS) Degree of Tamed Prostate Enlargement on Transabdominal Ultrasonography (TAUS) and Transrectal Ultrasonography (TRUS) Examination. Biomed J Indones. 2021;1(7):112-7
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effetivity of Dutasteride and Aloe Vera Extract Combination on Angiogenesis and Obstruction on Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT07065682
- Acronym / sponsor ID
- ALOE-DUTA-BPH / 22010119510006
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Keywords
- Aloe Vera, Benign prostate hyperplasia, VEGF, Prostate, dutasteride, uroflowmetry, prostatic hyperplasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Jul 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 a double blinded RCT with pre-post test design on the effect of combination of dutasteride and aloe vera, compared to dutasteride only, on uroflowmetry results, prostate volume, and VEGF serum level among patients with benign prostate hyperplasia. The treatment was given for 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dutasteride 0,5 mg/day + Aloe Vera Extract 380 mg/day | Experimental | Drug: Aloevera + dutasteride |
| Dutasteride | Active comparator | Drug: Dutasteride (0.5mg)Control |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with BPH clinically or radiologically (prostate volume > 30 gram, Qmax <15 mL/s)
- Willing to participate to the study
Key exclusion criteria (6 listed)
- Clinically or radiologically suspected of having prostatic cancer
- Previous prostatic surgery
- Patients with urinary retention
- Patients with BPH complications: urinary tract infections, urolithiasis, or hydroneprhosis
- Previously consumed alpha blocker or 5ARI in the last 6 months
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 |
|---|---|---|
| Aloevera + dutasterideDutasteride 0,5 mg/day + Aloe Vera Extract 380 mg/day | Drug | Dutasteride 0,5 mg/day + Aloe Vera Extract 380 mg/day |
| Dutasteride (0.5mg)Control | Drug | Dutasteride |
Primary outcome
Uroflowmetry result
Time frame: 12 weeks
Qmax of Uroflowmetry result
2 secondary outcomes
Prostatic volume
Time frame: 12 weeks
VEGF
Time frame: 12 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 15 Jul 2025.
- BackgroundNugroho E, Azhar A, Gunadi E. Relationship between Prostate Volume and International Prostate Symptom Score (IPSS) Degree of Tamed Prostate Enlargement on Transabdominal Ultrasonography (TAUS) and Transrectal Ultrasonography (TRUS) Examination. Biomed J Indones. 2021;1(7):112-7
- Individual participant dataSharing planned: No
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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.
Achmad Rizky Herda Pratama dr. Achmad Rizky Herda Pratama, Sp.U, S.H, Urologist contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aloevera + dutasteride and Dutasteride (0.5mg) in people with BPH (Benign Prostatic Hyperplasia), run by Universitas Diponegoro at 1 site in Indonesia.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Achmad Rizky Herda Pratama dr. Achmad Rizky Herda Pratama, Sp.U, S.H, Urologist (+6282184801976, herdapratama@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uroflowmetry result (time frame: 12 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 NCT07065682, which also lists 1 linked publication.
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 15 Jul 2025.