Status:

ACTIVE_NOT_RECRUITING

Effect of Eurycoma Longifolia (DLBS5055) and Multivitamins (Vitamin C+Vitamin E+ Β-carotene) for Infertile Males

Lead Sponsor:

Duta Wacana Christian University

Collaborating Sponsors:

Dexa Medica Group

Conditions:

Male Infertility

Eligibility:

MALE

20-45 years

Phase:

PHASE4

Brief Summary

Infertility is defined as the inability of a couple to get pregnant after one year of regular and unprotected sexual intercourse. Although it is not a life-threatening condition, infertile couple ofte...

Detailed Description

Study population will be idiopathic infertile males who come to the study site. Those who meet inclusion and exclusion criteria will be randomized into three groups (30 subjects each group). Therefore...

Eligibility Criteria

Inclusion

  • Male with idiopathic infertility
  • Age 20-45 years
  • Married and try to conceive.
  • Being registered with the Indonesian Social Health Insurance Administration Body (BPJS).
  • Has sperm concentration more than 5 million per mL.
  • Has testosterone level between 350-600 ng/dl.
  • Withdraw from any antioxidant treatment for at least 14 days before the enrollment of the study.
  • Able to understand and provide Informed Consent

Exclusion

  • Has a varicocele and other metabolic diseases such as diabetes mellitus.
  • Has a history of surgery or injury in the genital region.
  • Has a history of acute and chronic inflammatory diseases.
  • Has a known allergy to any ingredients of the active or placebo material of the tested drugs (Eurycoma longifolia, Vitamin C, Vitamin E and Beta-carotene).
  • Has a history of hormonal therapy in the last 6 months.
  • Consumes any herbal or traditional medicine.
  • Consumes any medicine contains steroid.

Key Trial Info

Start Date :

November 11 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 31 2025

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT06100432

Start Date

November 11 2023

End Date

October 31 2025

Last Update

March 27 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Laboratorium Klinik Pramita

Yogyakarta, Special Region of Yogyakarta, Indonesia