A prospective, randomized, double-blind clinical study to assess the impact of a dietary supplement called Turnera diffusa on healthy individuals who report having little sexual desire

ISRCTN	ISRCTN12819093
DOI	https://doi.org/10.1186/ISRCTN12819093
Sponsor	Evidenze Heath España SLU (CRO)
Funder	Pharmactive Biotech Products SLU

Submission date: 18/01/2026
Registration date: 19/01/2026
Last edited: 19/01/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ricardo Gallego
Principal investigator, Scientific

Fitback Medic
Av. Maresme, 14
El Masnou (Barcelona)
08320
Spain

ORCID ID	0000-0001-9671-8444
Phone	+34 (0)620 923 212
Email	ricardogallego@fitback.es

Dr Sonia Sanchez
Public, Scientific

Fitback women
Av. Maresme, 14
El Masnou (Barcelona)
08320
Spain

Phone	+34 (0)632 118 829
Email	soniasanchez@fitback.es

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Treatment
Scientific title	Prospective, randomised, double-blind clinical trial to evaluate the effect of a dietary supplement (Turnera diffusa) in healthy subjects who report low sexual desire
Study acronym	Liboost
Study objectives	We aimed to assess how effective and safe a standardized extract of Turnera diffusa (damiana) is when used alone to boost sexual desire in healthy volunteers who report low sexual desire after 8 weeks of treatment. Additionally we wanted to assess treatment compliance by participants at week 8 of treatment.
Ethics approval(s)	Approved 31/05/2022, CEIm (Committee on Ethics in Research with Medicines) Hospital Clínico San Carlos - Madrid (Spain) (Hospital Clínico San Carlos, Profesor Martín Lagos, s/n. - Puerta G - 4ª Norte, Madrid, 28040, Spain; +34 (0)91 330 38 19; ceic.hcsc@salud.madrid.org), ref: LIBDAM.22/280-EC_X
Health condition(s) or problem(s) studied	Low sexual desire
Intervention	Participants were randomly assigned in a 1:1 ratio through a computer-generated sequence to either receive Turnera diffusa extract at a dose of 500 mg per day (one tablet each morning) or a matching placebo for a duration of 8 weeks. The study products looked identical, and both the participants and the investigators were blinded for treatment allocation.
Intervention type	Supplement
Primary outcome measure(s)	Level of subjective sexual desire measured using subjective question: “How would you rate your level of sexual desire over the past week?” They responded using a 10-point visual analogue scale (VAS) at baseline and week 8
Key secondary outcome measure(s)	Female sexual function measured using Female Sexual Function Index (FSFI) and Sexual Desire Inventory (SDI) at baseline and week 8 Male sexual function measured using International Index of Erectile Function (IIEF) at baseline and week 8
Completion date	06/04/2025

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	110
Total final enrolment	53
Key inclusion criteria	1. The participant must have voluntarily signed the Informed Consent Form (ICF). 2. Aged between 18 and 65 years old. 3. Participant reports low sexual desire. 4. Able to complete self-administered questionnaires (PROs). 5. Must have completed one of the following questionnaires: 5.1. FSFI for women 5.2. IIEF (Erectile Function subdomain EF-IIEF) for men 6. Sexually active, regardless of type or frequency of sexual activity. 7. Sexually active women must agree to use contraceptive methods (hormonal contraceptives [oral, injectable, or implanted], tubal ligation, intrauterine device, barrier methods with spermicide, or partner vasectomy in the case of male partners) while taking the dietary supplement during the study. 8. Must have a smartphone device compatible with the study app.
Key exclusion criteria	1. Diagnosed with any sexual dysfunction. 2. Pregnant or breastfeeding women, or those who have given birth or had an abortion within the previous 3 months. 3. Women experiencing significant pain during sexual intercourse. 4. Individuals with unexplained genital bleeding. 5. Individuals with symptoms and/or signs compatible with genital infectious diseases. 6. Having any condition that could cause sexual dysfunction: 6.1. Poorly controlled type I or II diabetes 6.2. Hypertension requiring more than one antihypertensive or poorly controlled (diuretics in men frequently cause erectile dysfunction, impacting sexual desire) 6.3. Any type of heart disease (ischemic, heart failure, valvular, etc) 6.4. History of venous and/or arterial thromboembolic events 6.5. Other active cardiovascular conditions: stroke, intermittent claudication, etc. 7. Women with a history of cancer. 8. Currently receiving any treatment or medication that may produce symptoms related to sexual dysfunction: psychotropic drugs, antihypertensives, hypoglycemics, anticoagulants, or other medication deemed relevant by the investigator. 9. Currently receiving medication for the treatment of sexual dysfunction (PDE5 inhibitors, bupropion, etc). 10. Severe psychiatric disorder. 11. Any endocrinological, renal, hepatic, oncological, pulmonary, cardiovascular, psychological disease, substance addiction, or any other condition that, in the investigator’s judgment, could significantly interfere with sexual health. 12. Individuals with major relationship problems that interfere with sexual desire and/or sexual activity with their partner. 13. Individuals with known allergy or hypersensitivity to the dietary supplement used in the study. 14. Individuals with a criminal record or ongoing legal cases related to gender violence or sexual offenses.
Date of first enrolment	20/11/2022
Date of final enrolment	29/01/2025

Locations

Countries of recruitment

Spain

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

19/01/2026: Study's existence confirmed by the CEIm (Committee on Ethics in Research with Medicines) Hospital Clínico San Carlos - Madrid (Spain).