Health Condition 1: E291- Testicular hypofunction
Conditions
Interventions
None listed
Sponsors
Amaara Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male participants aged 35 to 55 years with BMI less than or equal to 30 kg per 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 study 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 study 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 study 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. Participant s 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 supplements for any other condition. 14. Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i.Change in total testosterone, free testosterone and cortisol levels (Baseline and Day 90) ii.Change in IIEF score (Erectile function, orgasmic function, sexual desire, satisfaction with intercourse, overall satisfaction) at Screening, Day 30, Day 60 and Day 90 iii.Change in Hypogonadism Impact of Symptoms Questionnaire (HIS Q) a validated patient reported outcome tool designed to assess symptom severity and impact on quality of life domains at Baseline, Day 30, Day 60 and Day 90. Timepoint: i. Baseline and Day 90 ii. Screening, Day 30, Day 60 and Day 90 iii. Baseline, Day 30, Day 60 and Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in severity & impact of fatigue on daily functioning through Fatigue Severity Score (FSS) at Baseline, day 30, day 60 & day 90. 2. Changes in the participant & investigator global assessment score at Baseline & Day 90. 3. Exploratory Endpoints: Semen Analysis & Serum Nitric Oxide at Baseline & Day 90.Timepoint: 1. Baseline, day 30, day 60 & day 90 2. Baseline & Day 90 3. Baseline & Day 90 | — |
Countries
India
Contacts
Public ContactMr Manoj Karwa
Amaara Ayurveda
Outcome results
None listed