RBR-8mrhgcc Evaluation of pain and quality of life using Uncaria Tomentosa (cat's claw) in patients with endometriosis

Date of registration: 02/01/2021 ^(mm/dd/yyyy)
Last approval date : 02/01/2021 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: ---

• Public title:

  en

  Evaluation of pain and quality of life using Uncaria Tomentosa (cat's claw) in patients with endometriosis

  pt-br

  Avaliação de dor e qualidade de vida com uso de Uncaria Tomentosa (unha de gato) em pacientes com endometriose

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:

Sponsors

• Primary sponsor: beatriz kehde
• Secondary sponsor:
  • Institution: beatriz kehde
• Supporting source:
  • Institution: beatriz kehde

Health conditions

• Health conditions:

  en

  Endometriosis, pelvic pain

  pt-br

  endometriose, dor pelvica

• General descriptors for health conditions:

  en

  N80 Endometriosis

  pt-br

  N80 Endometriose

• Specific descriptors:

Interventions

• Interventions:

  en

  The study will be a randomized, double-blind clinical trial, whose sample will consist of 42 women diagnosed with endometriosis who maintain pain even when using treatment with hormonal contraceptives. Evaluation will take place by a control group, receiving cat's claw, and the placebo group, receiving placebo. The proposed dosage is 500mg every 8 hours.

  pt-br

  O estudo será um ensaio clinico randomizado, duplo-cego, cuja amostra será constituída por 42 mulheres com diagnóstico de endometriose que mantenham dor mesmo em uso de tratamento com anticoncepcional hormonal. Avaliação se dará por um grupo controle, recebendo unha de gato, e o grupo placebo, recebendo placebo. A posologia proposta é 500mg a cada 8 horas.

• Descriptors:

  en

  N80 endometriosis

  pt-br

  N80 endometriose

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 03/01/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  42	F	0	0

• Inclusion criteria:

  en

  Inclusion criteria are patients with a diagnosis of endometriosis, confirmed by image examination, who maintain pain (visual analogue scale> 5) even when using drug treatment with hormonal contraceptives for at least 3 months before inclusion in the study.

  pt-br

  Os critérios de inclusão são pacientes com diagnostico de endometriose, comprovado por exame de imagem, que mantenham dor (escala analógica visual >5) mesmo em uso de tratamento medicamentoso com anticoncepcional hormonal por pelo menos 3 meses antes da inclusão no estudo.

• Exclusion criteria:

  en

  Exclusion criteria are patients without other types of clinical treatment, such as anastrozole, gestrionone, GnRH analogue; patients who are undergoing complementary treatment with physiotherapy, acupuncture, meditation; patients who are planning to become pregnant, pregnant and / or lactating, use opioid-based painkillers or who are diagnosed with another pelvic disease such as intestinal and urinary disorders.

  pt-br

  Os critério de exclusão são pacientes sem outros tipo de tratamento clínico, como anastrozol, gestrionona, análogo de GnRH; pacientes que estejam em tratamento complementar com fisioterapia, acupuntura, meditação; pacientes que estejam planejando engravidar, gestante e/ou lactante, façam uso de analgésicos a base de opióides ou que tenham diagnóstico de outra doença pélvica como intestinais e urinárias.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Parallel	2	Double-blind	Randomized-controlled	3

Outcomes

• Primary outcomes:

  en

  It is expected to find a difference in the use of Uncaria tomentosa for pain control in patients with endometriosis.

  pt-br

  Espera-se encontrar diferença no uso de Uncaria tomentosa para controle da dor em pacientes com endometriose.

• Secondary outcomes:

Contacts

• Public contact
  • Full name: Eduardo Schor
  • • Address: Rua Botucatu 821
    • City: São Paulo / Brazil
    • Zip code: 04023-061
  • Phone: + 55 11 5576 4848 VoIP 2856
  • Email: eduardo@clinicaschor.med.br
  • Affiliation:
   
• Scientific contact
  • Full name: Beatriz Herzog Kehde
  • • Address: Rua Esmeralda 165
    • City: São Paulo / Brazil
    • Zip code: 01531-040
  • Phone: +5511999627979
  • Email: biakehde@gmail.com
  • Affiliation:
   
• Site contact
  • Full name: Departamento de Ginecologia Setor de Algia Pélvica UNIFESP
  • • Address: Rua Napoleão de Barros, 608 - Vila Clementino
    • City: São Paulo / Brazil
    • Zip code: 04024-002
  • Phone: + 55 11 5576 4848 VoIP 2856
  • Email: beatriz.kehde@huhsp.org.br
  • Affiliation:
   

Additional links:

• Download in ICTRP format