A Clinical Trial to Investigate the Efficacy and Safety of Tongkat Ali Maca Plus
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

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.
    

Detailed description: 
      Sexual health is fundamental to the physical and emotional health and wellbeing of
      individuals, couples and families, and to the social and economic development of communities
      and countries" says the World Health Organization. Erectile dysfunction (ED) is defined as
      the inability to achieve and maintain a penile erection adequate for satisfactory sexual
      intercourse. ED may affect physical and psychosocial health and may have a significant impact
      on the quality of life (QoL) of sufferers and their partners. It is a common cross-cultural
      condition in developing and industrialized countries, but its true incidence is probably
      underestimated owing to the embarrassment of seeking help.

      Data from the Massachusetts Male Aging Study (MMAS), a community based, random sample
      prospective observational survey of non-institutionalized men aged 40-70years, found that 52%
      of men reported erectile dysfunction. ED is commonly classified into three categories based
      on its etiology. These include organic, psychogenic and mixed ED. However, this
      classification should be used with caution since most cases are actually of mixed etiology.
      It is therefore suggested to use the term primary organic or primary psychogenic.
      Phosphodiesterase type 5 inhibitors are the standard care and treatment for most mild to
      moderate ED patients. Most common side effects of phosphodiesterase-5 inhibitors are in the
      form of headache, visual abnormalities, nasal congestion, dyspepsia, and myalgia.

      Enhancing healthy sexuality is possible with the use of natural plants and nutrients. In
      Asia, men consider herbal medicine to be a reliable treatment for improving overall
      wellbeing, including sexual wellbeing.

      In Malaysia the root of Eurycoma longifolia, known traditionally as Tongkat Ali, is one of
      the most popular herbs used for well-being. It is used to increase fertility and sexual power
      and is claimed to improve strength and power during sexual activities. Many studies carried
      out on rats and mice have found that administration of E. longifolia extracts increases the
      sexual arousal and motivation and frequency of sexual activity. These effects are similar to
      those caused by administration of testosterone, although the effect of Tongkat Ali is not as
      strong. Tongkat Ali is reputed to increase testosterone effect. It was found to have
      androgenic effects in male rats, either directly or indirectly, such as increasing the weight
      of sexual accessories. The effect of this plant is dependent upon the dose; whether or not it
      contributes significantly to the aphrodisiac qualities of Tongkat ali can only be established
      with more research.

      A recent systematic review with meta-analysis concluded that the herbal extract of Tongkat
      Ali may have clinical effect on erectile function. However, more efficacy trials are
      warranted to further support current evidence.

      Maca (Lepidium meyenii) is an Andean plant that belongs to the brasslike (mustard) family. It
      has been used for centuries in enhancing the fertility in humans and animals. Preparations
      from the Maca root have been reported to improve sexual function in healthy populations.
      There is a hypothesis questioning if Maca is effective in improving sexual function.
      Spermatogenic and fertility-enhancing activities are suggested through animal experiments.
      Some in-vivo studies have shown that Maca may improve sexual behavior and enhance
      androgen-like effects in rats. Recent clinical trials have also suggested significant effects
      of Maca for increasing sperm count and mobility and improving sexual function in humans.

      However, these data are insufficient for determining whether Maca is clinically effective.

      The results of a recent systematic review provide suggestive evidence for the effectiveness
      of Maca in improving semen quality.

      By today, robust clinical data on Tongka tali and Maca safety and efficacy is not sufficient.
      This study was conducted to evaluate Efficacy and Safety of Tongkat Ali Maca Plus for the
      improvement of sexual well-being and quality of life in men with mild to moderate erectile
      dysfunction.
    

Intervention name(s): Tongkat Ali Maca Plus
Intervention type(s): Dietary Supplement
Intervention description(s): 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).
Other intervention name(s): Placebo Comparator: Placebo (starch) in 3 capsules size 1 (0 mg of active ingredient)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tongkat Ali and Maca