Health Condition 1: null- Male Subjects with signs and symptoms of Low libido
Conditions
Interventions
Intervention1: Tentex forte Capsules: 2 capsules twice daily for 30 days
Control Intervention1: Placebo capsules: 2 capsules twice daily for 30 days
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: Males aged 18 and above. Total Testosterone level At least one symptom of low libido clinically identified which include decreased sexual drive or decreased energy, in not less than 3 months. Hematologic and biochemical parameters within acceptable normal limits Willingness to sign informed consent form
Exclusion criteria
Exclusion criteria: Individuals with established/known organic pathology for sexual weakness. Body Mass Index (BMI) >37kg/m2 at screening Severe Lower Urinary Tract Infection and /or significant prostate enlargement Patients receiving other long- acting intramuscular (IM) Testosterone undecanoate or Testosterone pellets in the 6 month period prior to screening. Patients with evidence of renal, hepatic or cardiac failure. History of HIV infection Patients with gastro-enteritis, diabetes and endocrine disorders. Patients on long-term steroidal treatment. Untreated hypothyroidism, hypercortisolism or other significant endocrinopathy other than hypogonadism that contribute to symptoms of low energy or fatigue. Not willing to sign informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and efficacy of Tentex forte capsule in Low libido. Rapid recovery from symptoms. Compare with the changes in Total Serum Testosterone Level between the study group and placebo group. Timepoint: Day 1 Day 15 Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence of adverse events during the study period and overall compliance to the drug treatmentTimepoint: Day 1 Day 15 Day 30 | — |
Countries
India
Contacts
Public ContactDr Ajay Kumar Sahu
National Institute of Ayurved
Outcome results
None listed