A Clinical Trial to Investigate the Efficacy and Safety of Tongkat Ali Maca Plus

NCT05347329 | Completed

• 1 other identifier: TongMac 19052016
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

This was a randomized, double blind, placebo-controlled, Three-arm, multicenter, parallel groups, interventional phase II clinical trial evaluating the efficacy, and safety of a herbal medicinal product of dried roots of Eurycoma longifolia Jack (Tongkat Ali) and dried tuberous roots of Lepidium meyenii (Maca) for the improvement of sexual well-being and quality of life in men.

Conditions

Erectile Dysfunction

Keywords

Tongkat Ali and Maca

Outcome Measures

Primary Outcomes (2)

• To explore the effect of Tongkat Ali and Maca dried roots extracts (Tongkat Ali Maca Plus) on sexual performance

  sexual performance will be measured by the change in the International Index of Erectile Function questionnaire score

  12 weeks

• To explore the safety of Tongkat Ali Maca Plus as measured by the occurrence of adverse events

  the safety of Tongkat Ali Maca Plus will be measured by the occurrence of adverse events

  12 weeks

Secondary Outcomes (3)

• To explore the effect of Tongkat Ali Maca Plus on serum levels of free and total testosterone.

  12 weeks

• To explore the effect of Tongkat Ali Maca Plus on sexual wellbeing

  12 weeks

• To explore the effect of Tongkat Ali Maca Plus on quality of life

  12 weeks

Study Arms (3)

Control Arm 1

PLACEBO COMPARATOR

Placebo (starch) in 3 capsules size 1 (0 mg of active ingredient), administered orally once daily on empty stomach with plenty of water.

Dietary Supplement: Tongkat Ali Maca Plus

400 mg Tongkat Ali+ 200 mg Maca (Experimental Arm 2)

EXPERIMENTAL

The content of 2 capsules of Tongkat Ali Maca (600 mg of active ingredient), Plus is equally distributed and inserted into 3 capsules size 1 (low dose), administered orally once daily with plenty of water.

Dietary Supplement: Tongkat Ali Maca Plus

600 mg Tongkat Ali+ 300 mg Maca ( Experimental Arm 3)

EXPERIMENTAL

The content of 3 capsules of Tongkat Ali Maca Plus (900 mg of active ingredient), is equally distributed and inserted into 3 capsules size 1 (high dose), administered orally once daily with plenty of water.

Dietary Supplement: Tongkat Ali Maca Plus

Interventions

Tongkat Ali Maca Plus DIETARY_SUPPLEMENT

Tongkat Ali and Maca (Tongkat Ali: powdered extract 200 mg (from roots of Eurycoma longifolia Jack) + Maca: powdered extract 100 mg (from dried tuberous root of Lepidium meyenii).

Also known as: Placebo Comparator: Placebo (starch) in 3 capsules size 1 (0 mg of active ingredient)

400 mg Tongkat Ali+ 200 mg Maca (Experimental Arm 2); 600 mg Tongkat Ali+ 300 mg Maca ( Experimental Arm 3); Control Arm 1

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male aged between 35 and 65 years.
• Patients with mild, mild to moderate or moderate Erectile Dysfunction as defined by International Index of Erectile Function-5 (IIEF-5) score ≥8 and ≤21.
• Patients with decreased libido according to self-report.
• Patients in a stable heterosexual relationship for at least 6 months and willing to continue efforts at sexual activity for the duration of the study.
• Patients willing to stop any other medications for erectile dysfunction throughout study duration.
• Able and willing to provide written informed consent

You may not qualify if:

• Patients with history of prostate cancer
• Patients with free: total prostate-specific antigen (PSA) ratio ≤ 0.15 or PSA \> 4 ng/ml.
• Patients with acute or chronic prostatitis during the screening visit.
• Patients with Penile anatomical abnormalities
• Patients with pregnant partners or partners planning to become pregnant during the study.
• Clinically significant abnormality of physical examination that from investigator's point of view may interfere with study treatment.
• Any medical or psychological condition or social circumstances that would impair subject's ability to participate reliably in the study.
• Testosterone implant during 6 months prior to screening.
• Subjects for whom sexual activity is inadvisable.
• Uncontrolled hypertension according to ESC/ESH guidelines.
• Uncontrolled hypotension as defined by average SBP \< 90 mmHg or average DBP \<60 mmHg.
• Uncontrolled diabetes mellitus as defined by HbA1c ≥ 7%.
• Alcohol or substance abuse or dependence within the past six months.
• Recent major relationship changes, disruption, or turmoil
• Patients with any major psychiatric disorder (including major depression or schizophrenia).

Sponsors & Collaborators

• Natural Wellness Egypt: lead

Study Sites (1)

Faculty of Medicine, Menoufia University/ Egypt

Shibīn al Kawm, Menoufia, Egypt

Location

Related Publications (12)

• Salonia A, Castagna G, Sacca A, Ferrari M, Capitanio U, Castiglione F, Rocchini L, Briganti A, Rigatti P, Montorsi F. Is erectile dysfunction a reliable proxy of general male health status? The case for the International Index of Erectile Function-Erectile Function domain. J Sex Med. 2012 Oct;9(10):2708-15. doi: 10.1111/j.1743-6109.2012.02869.x. Epub 2012 Aug 15.

  PMID: 22897643 BACKGROUND

• Johannes CB, Araujo AB, Feldman HA, Derby CA, Kleinman KP, McKinlay JB. Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts male aging study. J Urol. 2000 Feb;163(2):460-3.

  PMID: 10647654 BACKGROUND

• Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.

  PMID: 8254833 BACKGROUND

• Ismail SB, Wan Mohammad WM, George A, Nik Hussain NH, Musthapa Kamal ZM, Liske E. Randomized Clinical Trial on the Use of PHYSTA Freeze-Dried Water Extract of Eurycoma longifolia for the Improvement of Quality of Life and Sexual Well-Being in Men. Evid Based Complement Alternat Med. 2012;2012:429268. doi: 10.1155/2012/429268. Epub 2012 Nov 1.

  PMID: 23243445 BACKGROUND

• Kotirum S, Ismail SB, Chaiyakunapruk N. Efficacy of Tongkat Ali (Eurycoma longifolia) on erectile function improvement: systematic review and meta-analysis of randomized controlled trials. Complement Ther Med. 2015 Oct;23(5):693-8. doi: 10.1016/j.ctim.2015.07.009. Epub 2015 Jul 31.

  PMID: 26365449 BACKGROUND

• Gonzales GF. Ethnobiology and Ethnopharmacology of Lepidium meyenii (Maca), a Plant from the Peruvian Highlands. Evid Based Complement Alternat Med. 2012;2012:193496. doi: 10.1155/2012/193496. Epub 2011 Oct 2.

  PMID: 21977053 BACKGROUND

• Lee MS, Lee HW, You S, Ha KT. The use of maca (Lepidium meyenii) to improve semen quality: A systematic review. Maturitas. 2016 Oct;92:64-69. doi: 10.1016/j.maturitas.2016.07.013. Epub 2016 Jul 21.

  PMID: 27621241 BACKGROUND

• Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. N Engl J Med. 1998 May 14;338(20):1397-404. doi: 10.1056/NEJM199805143382001.

  PMID: 9580646 BACKGROUND

• Meuleman E, Cuzin B, Opsomer RJ, Hartmann U, Bailey MJ, Maytom MC, Smith MD, Osterloh IH. A dose-escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction. BJU Int. 2001 Jan;87(1):75-81. doi: 10.1046/j.1464-410x.2001.00998.x.

  PMID: 11121996 BACKGROUND

• Tan HM, Moh CL, Mendoza JB, Gana T, Albano GJ, de la Cruz R, Chye PL, Sam CC. Asian sildenafil efficacy and safety study (ASSESS-1): a double-blind, placebo-controlled, flexible-dose study of oral sildenafil in Malaysian, Singaporean, and Filipino men with erectile dysfunction. The Assess-1 Study Group. Urology. 2000 Oct 1;56(4):635-40. doi: 10.1016/s0090-4295(00)00688-9.

  PMID: 11018621 BACKGROUND

• Zenico T, Cicero AF, Valmorri L, Mercuriali M, Bercovich E. Subjective effects of Lepidium meyenii (Maca) extract on well-being and sexual performances in patients with mild erectile dysfunction: a randomised, double-blind clinical trial. Andrologia. 2009 Apr;41(2):95-9. doi: 10.1111/j.1439-0272.2008.00892.x.

  PMID: 19260845 BACKGROUND

• Tambi MI, Imran MK, Henkel RR. Standardised water-soluble extract of Eurycoma longifolia, Tongkat ali, as testosterone booster for managing men with late-onset hypogonadism? Andrologia. 2012 May;44 Suppl 1:226-30. doi: 10.1111/j.1439-0272.2011.01168.x. Epub 2011 Jun 15.

  PMID: 21671978 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Starch

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Prof Dr. Mohamed badreldin, MD

  Menoufia University/ Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The arms randomization was performed using Interactive web response system (IWRS).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a randomized, double blind, placebo-controlled, Three-arm, multicenter, parallel groups, interventional phase II clinical trial evaluating the efficacy, and safety of a herbal medicinal product of dried roots of Eurycoma longifolia Jack (Tongkat Ali) and dried tuberous roots of Lepidium meyenii (Maca) for the improvement of sexual well-being and quality of life in men.

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: September 10, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)