A study on Tentex forte capsules in the treatment of Low sexual energy in males
- Conditions
- Health Condition 1: null- Male Subjects with signs and symptoms of Low libido
- Registration Number
- CTRI/2018/04/013112
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Males aged 18 and above.
Total Testosterone level <= 300 ng/dl at the screening.
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method