RBR-6qbx4h6 Study of formulations containing extract of Acmella oleracea (L.) R.K. Jansen (Asteraceae) (Jambu) in patients with decr...

Date of registration: 11/22/2021 ^(mm/dd/yyyy)
Last approval date : 11/22/2021 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code:

• Public title:

  en

  Study of formulations containing extract of Acmella oleracea (L.) R.K. Jansen (Asteraceae) (Jambu) in patients with decreased sexual potency or rapid ejaculation

  pt-br

  Estudo de formulações contendo extrato de Acmella oleracea (L.) R.K. Jansen (Asteraceae) (Jambu) em pacientes com diminuição da potencia sexual ou ejaculação rápida

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • U1111-1266-9427
    Issuing authority:
  • 21112819600000003
    Issuing authority: plataforma brasil
  • 3.799.796
    Issuing authority: comite de etica em pesquisa/UNIFAP

Sponsors

• Primary sponsor: Universidade Federal do Amapá
• Secondary sponsor:
  • Institution: Universidade Federal do Amapá
• Supporting source:
  • Institution: Universidade Federal do Amapá

Health conditions

• Health conditions:

  en

  Premature Ejaculation; Erectile Dysfunction

  pt-br

  Ejaculação Precoce; Disfuncao Erétil

• General descriptors for health conditions:

  en

  F52 Sexual dysfunction

  pt-br

  F52 Disfunção sexual

• Specific descriptors:

  en

  F52.4 Premature Ejaculation

  pt-br

  F52.4 Ejaculação Precoce

  en

  N48.4 Erectile Dysfunction

  pt-br

  N48.4 Disfunção Erétil

Interventions

• Interventions:

  en

  A group of 30 patients with erectile dysfunction and another 30 with rapid ejaculation. They will receive topical application of a spray containing alcoholic extract of Acmella Oleracea (JAMBU) on the skin that covers the glans penis, as well as on the glans penis 5 min before each sexual act (vaginal penetration) on average 2x/week for 12 weeks. the comparative group will be the same group of patients as they will be previously evaluated with respect to the Vaginal Latency Interval - time it takes to ejaculate after penetration, for the rapid ejaculation group, and for the erectile dysfunction group before having -á the sum value of the international index of erectile function. thus, after the proposed period, the values before and after the intervention will be compared.

  pt-br

  Grupo de 30 pacientes com disfunção erétil e outro também com 30 que apresentem ejaculação rápida. Receberão aplicação tópica de um spray contendo extrato alcoólico de Acmella Oleracea (JAMBU) na pele que reveste a glande peniana, bem como na glande 5 min antes de cada ato sexual (penetração vaginal) em media 2x/sem por 12 semanas. o grupo comparativo será o mesmo grupo de pacientes, pois previamente eles serão avaliados com relação ao Intervalo de latência vaginal- tempo que leva pra ejacular após a penetração, para o grupo de ejaculação rápida, e para o grupo de disfunção erétil previamente ter-se-á o valor de soma do índice internacional de função erétil. assim, após o periodo proposto serão comparados os valores pré e após a intervenção.

• Descriptors:

  en

  Z92 Medical treatment

  pt-br

  Z92 Tratamento médico

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 12/01/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  40	M	18 Y	60 Y

• Inclusion criteria:

  en

  male, erectile dysfunction, stable affective relationship, fixed single partner, patients with premature ejaculation

  pt-br

  masculino, diagnóstico clínico de disfunção erétil, relação afetiva estável, parceiro único fixo, ejaculação precoce

• Exclusion criteria:

  en

  anatomical genital deformities; erectile dysfunction secondary to spinal cord injury, concomitant diagnosis of other sexual dysfunctions , prolactin level greater than three times the upper limit, testosterone level less than 300, uncontrolled psychiatric disorder, decompensated diabetes mellitus, history of stroke, myocardial infarction, significant cardiovascular disease, poorly controlled arterial hypertension, history of important hematological, renal, hepatic abnormalities, abuse of illicit substances

  pt-br

  deformidades anatômicas genitais; disfunção erétil secundária à lesão medular, diagnóstico concomitante de outras disfunções sexuais, ,nível de prolactina maior que três vezes o limite superior, nível de testosterona total menor que 300, transtorno psiquiátrico descontrolado, diabetes mellitus descompensado, história de acidente vascular encefálico, infarto do miocárdio, doença cardiovascular significativa, hipertensão arterial mal controlada, história de importantes anormalidades hematológicas, renais, hepáticas, abuso de substâncias ilícitas

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Single-group	1	Open	Single-arm-study	N/A

Outcomes

• Primary outcomes:

  en

  It is expected that with the method used, participating patients present improvements in the evaluated indices, either the increase in the mean ejaculatory latency interval and/or the international index of erectile function.

  pt-br

  Espera-se que com o método utilizado os pacientes participantes apresentem melhoras nos índices avaliados, seja o aumento da media do intervalo de latência ejaculatório e/ou o índice internacional de função erétil.

• Secondary outcomes:

  en

  Secondary outcomes are not expected

  pt-br

  Não são esperados desfechos secundários

Contacts

• Public contact
  • Full name: LECILDO LIRA BATISTA
  • • Address: JK ROD. 4440
    • City: MACAPÁ / Brazil
    • Zip code: 68903419
  • Phone: +5596991794988
  • Email: lecildolira@unifap.br
  • Affiliation:
   
• Scientific contact
  • Full name: JOSE CARLOS CARVALHO
  • • Address: JK ROD. KM 02
    • City: MACAPÁ / Brazil
    • Zip code: 68903419
  • Phone: +5596999022992
  • Email: jctcarvalho@gmail.com
  • Affiliation:
   
• Site contact
  • Full name: LECILDO LIRA BATISTA
  • • Address: JK ROD. 4440
    • City: MACAPÁ / Brazil
    • Zip code: 68903419
  • Phone: +5596991794988
  • Email: lecildolira@unifap.br
  • Affiliation:
   

Additional links:

• Download in ICTRP format