Health Condition 1: E291- Testicular hypofunction
Conditions
Interventions
None listed
Sponsors
Amaara Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: 1)Male participants aged 35 to 50 years (both inclusive) with BMI not more than 30 kg/m2 2)Participants who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit 3)Participants with positive Saint Louis University Androgen Deficiency in Aging Males (ADAM) questionnaire indicative of testosterone deficiency at screening visit 4)Participants should be in an active stable sexual relationship (only married participants) for the entire duration of the study 5)Participants willing to participate in clinical trials and who have read understood and signed the informed consent form
Exclusion criteria
Exclusion criteria: 1)Previous events or other severe conditions that may affect sexual health or metabolic health 2)Participants with genital anatomical deformities, including but not limited to penile deformities 3)Participants for whom sexual activity is inadvisable because of their underlying disease status 4)Female partners experiencing sexual dysfunction such as painful intercourse low libido or other forms of sexual dysfunction as well as pregnant individuals 5)Participants with any significant comorbid condition or currently undergoing pharmacological treatment which in the investigators judgment may interfere with the clinical trial outcomes 6)Participants that have undergone radical prostatectomy spinal cord injury or any other surgery of urogenital organs 7)Participants with a history or presence of significant alcoholism or drug abuse within the past 1 year 8)Participants with a history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco or nicotine products more than 10 times per day 9)Any concomitant treatment that is not permissible including but not limited to nitrates anti-androgens chemotherapy agents radiotherapy etc 10)Recent participation in another clinical trial or receiving some other drug during the study besides that in the protocol 11)Known hypersensitivity to any of the ingredients of the investigational product 12)Participants concurrent use of sildenafil or other such drugs in the PDE5 inhibitor family energy supplements herbal or pharmaceutical aphrodisiacs body composition enhancing agents or other concurrent medication such as beta blockers contraceptives and psychotropic medications nutraceuticals or ayurvedic supplement for sexual health and well-being 13) Participants consuming any nutraceutical herbal or ayurvedic supplement for any other condition 14) Any other clinical condition in the investigator judgment finds the study participation unsuitable for the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Changes in levels of total testosterone, free testosterone, cortisol, and nitric oxide 2) Changes in metabolic parameters like fasting blood sugar, fasting insulin and lipid profile 3) Changes in libido system score (LSS) score 4) Changes in the international index of erectile function (IIEF) (erectile and orgasmic functions, sexual desire, satisfaction with intercourse, and overall sexual satisfaction) 5) Changes in sexual stamina using intravaginal ejaculatory latency time (IVELT) scoreTimepoint: 1)screening and day 90 2)screening and day 90. 3)screening day 30, day 60 and day 90 4)screening, day 30, day 60 and day 90 5)screening, day 30, day 60 and day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Changes in perceived stress scale (PSS) score 2)Changes in Fatigue Severity Scale (FSS) score 3)Changes in COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score 4)Changes in STAI (State-Trait Anxiety Inventory) score 5)Changes in Profile of Mood State (POMS) questionnaire score 6)Changes in Personal Assessment of Intimacy in Relationships (PAIR) (to be filled by partner) score 7)Changes in the gastrointestinal symptom rating scale (GSRS) scoreTimepoint: 1)screening day 30 day 60 and day 90 2)screening day 30 day 60 and day 90 3)screening and day 90 4)screening and day 90 5)screening and day 90 6)screening and day 90 7)screening and day 90 | — |
Countries
India
Contacts
Public ContactAmandeep Singh
Amaara Ayurveda
Outcome results
None listed