D004 (Palmex) vs Saw palmetto, Finasteride and Tamsulosin in patients with BPH

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

D4SFT

Scientific title:

Comparative study of medium-term effects of Palmex (D-004), Saw palmetto,Finasteride and Tamsulosin in patients with Benign prostatic hyperplasia

Acronym of Scientific Title:

D4SFTHPB

Secondary indentifying numbers:

D004-08

Issuing authority of the secondary identifying numbers:

National Centre for Scientifc Research

Source(s) of monetary or material support:

National Centre for Scientific REsearch, BioCubaFarma Central Account

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Raul

Last name:

Guzman Mederos

Medical Specialty :

Specialist of second degree in Urology

Affiliation:

Surgical Clinical Teaching Hospital "Dr. Salvador Allende"

Postal address:

Calzada del Cerro number 1551, Cerro

City:

Havana

Country:

Cuba

Zip Code:

12000

Telephone:

+53-78705590

Email address:

raul.guzman@infomed.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, CIMEQ, Monica I Reyes Bello, MD. First degree specialist in Urology

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/09/2021

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Benign Prostatic Hyperplasia

Health condition(s) code:

Prostatic Hyperplasia

Prostatic Diseases

Genital Diseases, Male

Male Urogenital Diseases

Health condition keyword:

BPH

Intervention(s):

Experimental Group 1, Palmex (320 mg): 1 softgel capsules daily, by oral route, before bedtimefor 6 months. Control Group: Saw palmetto (320 mg): 1 softgel capsule daily, by oral route, before bedtime for 6 months. Control Group: Finasteride (5 mg): 1 tablet daily, by oral route, before bedtime for 6 months. Control Group: Tamsulosin (0,4 mg): 1 capsule daily, by oral route, before bedtime for 6 months.

Intervention code:

Dietary Supplements

Plant Extracts

Sabal serrulatum

Finasteride

Tamsulosin

Capsules

Tablets

Administration, Oral

Intervention keyword:

Palmex

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Maximum urinary flow (mL/s) (Improvement of the values of the maximum urinary flow at the end of the treatment with respect to the initial values, evaluated by uroflowmetry). Measurement time: At baseline and, 6 months.

Key secondary outcomes:

1. IPSS scale (Significant reduction of the values of the IPSS scale at the end of the treatment with respect to the initial values). Measurement time: At baseline and, 2, 4 and 6 months of treatment. 2. Size of the prostate (mm) (Reduction of the size of the prostate with respect to the baseline value evaluated by transrectal ultrasound). Measurement time: At baseline and, 6 months of treatment. 3. Residual volume (mL) (Reduction of residual volume with respect to baseline value evaluated by transrectal ultrasonography). Measurement time: At baseline and, 6 months of treatment.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male

Minimum age:

40 years

Maximum age:

80 years

Inclusion criteria:

Those patients who meet the recruitment criteria (men ≥ 40 years of age who have signed the informed consent and with mild or moderate lower urinary tract symptoms (LUTS). IPSS ≥ 1, <19-) and with prostate enlargement verified by digital rectal examination.

Exclusion criteria:

Patients with Prostate cancer. Previous history of urological surgery (prostate, bladder or urethral). Urinary retention. Prostate antigen (PSA) values> 4 ng / mL. Presence of the middle lobe when performing transrectal ultrasound History of liver failure. History of chronic kidney failure. Blood pressure> 180/110 mmHg. Other active diagnosed neoplasms. Alcoholism. Psychiatric problems that limit the IPSS response. Treatment with ADR-α1 antagonists, 5 α-reductase inhibitors, androgens, antiandrogens, cholinergics, anticholinergics, steroids and /or phytotherapeutic treatments in the 6 months prior to the study. Usual clinical history of allergy to medications or any other special condition that, in the opinion of the doctor, puts your health and life at risk during the study

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

200

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Clinical Trails Unit, National Centre for Scientific Research

Postal Address:

Avenue 25 and 158 st, Cubanacan, Playa

City:

Havana

Country:

Pais

Zip Code:

11300

Telephone:

+53-59958136

Email :

julio.fernandez@cnic.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Clinical Traials Unit, National Centre for Scientific Research

Postal Address:

Avenue 25 and 158 st, Cubanacan, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-59958136

Email :

julio.fernandez@cnic.cu [2]

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Surgical Clinical Teaching Hospital "Dr. Salvador Allende"

Surgical Medical Research Center (CIMEQ)

Status of evaluation:

Approved

In review

Status of evaluation date of Ethic Committee:

22/03/2021

15/03/2021

Postal address of Ethic Committee :

Calzada del Cerro 1551 corner Dominguez, Cerro, Havana, ZC 12000, Cuba

216th and 11Bth Street, Siboney, Playa ZC 12100, Cuba

Telephone:

+53-78776354

+53-78581000

Email:

sallende@infomed.sld.cu

cimeq@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

01/06/2022

Date of available results:

01/10/2022

Date of first publication:

01/12/2022

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000373

Date of Registration in Primary Registry:

27/05/2021

Record Verification Date:

2021/06/15

Next update date:

2022/06/15

Link to the spanish version:

Click here [3]