This is a mono-center study wherein the efficacy and safety of formulation for vitality, vigour, sexual well-being will be studied in adult male patients.
- Conditions
- Health Condition 1: F529- Unspecified sexual dysfunction notdue to a substance or known physiological condition
- Registration Number
- CTRI/2020/05/025286
- Lead Sponsor
- Sami Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1 Married male subjects of age ranging from 35-60 years with both years inclusive (minimum age being 35 years and maximum age being 60 years).
2 Complaints with symptoms of fatigue and diminished vitality with AMS questionnaire score >=27 and <= 42.
3 Self-reported Mild to moderate Erectile problems with IIEF-5 score >=12 and <= 21 with difficulty in maintaining erection or premature ejaculation.
4 The subjects must be in a marital relationship (Married), having stable monogamous sexual relationship with a female for a minimum of last 06 months and continue throughout till the end of the study.
5 Physically active and Planning to have regular sexual activity.
6 Commitment to comply with study protocol requirements.
7 Willing to sign informed consent.
1 History of smoking, alcohol intake and narcotic/drug abuse within 3 months before Screening.
2 Subjects who want to lose weight or looking for weight loss program or significant lifestyle related modifications during the study.
3 History of surgical interventions or subjects with major psychiatric and neurological disorders such as Schizophrenia,Mental disorders, Alzheimerâ??s, Parkinsonism and Epilepsy, Multiple sclerosis etc.), major trauma or infections that are associated with the development of symptoms of ED and considered a potential cause of ED, severe systemic disorders including blood diseases and leukemias.
4 Having genital abnormalities or anatomical deformity of the penis including severe penile fibrosis or Peyronies disease or phimosis or any other condition which prevents normal sexual intercourse.
5 With blood pressure more than or equal to 140/85 mmHg and those who were on a â??chronic useâ?? for a minimum of 12 months or more of the following class of drugs viz Diuretics, Beta blockers and Calcium channel blockers.Subjects with blood pressure less than 140/85 and on monotherapy or low dose combination therapy without change in the dose from past 06 months need not be excluded.
6 Subjects with HbA1c >= 6.5.
7 Subjects with history of clinically significant thyroid disorder (hypo or hyper), gastrointestinal, cardiovascular, haematological, hepatic (SGOT or SGPT levels > 2 times Upper Limit of Normal),renal (serum creatinine >= 1.3 mg/dl),dialysis,respiratory or genitourinary abnormalities or diseases.
8 BMI > 30 Kg/m2.
9 Subjects detected with HIV and suffering from AIDS or on antiviral or anti-retroviral therapy.
10 Subjects with any clinically significant laboratory or ECG findings during screening.
11 Those subjects with Premature Ejaculation and organic impotence and clinically defined prostatitis and who have undergone pelvic surgery.
12 Subjects who are taking medications for erectile dysfunction, Phosphodiesterase Type-5 Inhibitors including sildenafil, tadalafil, vardenafil, avanafil must stop using these medications for at least 04 weeks before baseline visit.
13 Subjects those are not willing to stop taking the vitamins and supplements including herbal during the course of the study.
14 Subject who are allergic to herbal supplements and medications.
15 Subjects continuing tricyclic antidepressant and atypical antipsychotic drugs for the last 03 months.
16 Subject having participated in any clinical trial within last 03 months or any trial for testosterone boosting or ED,vigour,vitality, male sexual health and performance trials.
17 Subjects not ready to provide the identification proof i.e. Age and Gender,not ready to sign the consent and unable to comply with the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Improvement in psychological, somatic and sexual improvement through change in Aging Maleâ??s Symptom Scale. <br/ ><br>2 Improvement in erectile function in comparison to placebo through Improvement in IIEF-5 questionnaire score.Timepoint: 1 Aging Maleâ??s Symptom Scale(Screening,Day30 and Day60). <br/ ><br>2 IIEF-5 questionnaire (Screening,Day30 and Day60).
- Secondary Outcome Measures
Name Time Method 1 Change in total and free blood Testosterone level in comparison with placebo. <br/ ><br>2 Change in Salivary Cortisol level in comparison with placebo. <br/ ><br>3 Improvement in Health-Related Quality of Life through SF-36 Version 1 RAND Corporation questionnaire and AMS score <br/ ><br>4 Safety will be assessed through occurrence of AE during the study duration, change in vital signs from screening to final visit. <br/ ><br>5 Overall wellbeing through other parameters in comparison to placebo. <br/ ><br>6 Hs-CRP test.Timepoint: 1 Blood total and free Testosterone level(Baseline,Day30 and Day60). <br/ ><br>2 Salivary Cortisol level (Baseline and Day60). <br/ ><br>3 SF-36 and AMS score (Screening,Day30 and Day60) <br/ ><br>4 AE and change in vital signs (Day30,Day60 and Day75(telephonic follow-up)) <br/ ><br>5 Overall wellbeing through other parameters in comparison to placebo(Day30,Day60 and Day75(telephonic follow-up). <br/ ><br>6 Hs-CRP test (Day0 and Day60).