A clinical study to evaluate the safety and efficacy of VISPO in healthy subjects.

Not yet recruiting

Brief Summary: This is a double blind, placebo controlled, parallel group,two-arm, prospective clinical study. Healthy subjects meeting all inclusion andno exclusion criteria, after signing a written informed consent will beenrolled in the study.After passing the eligibility criteria, subjects will berandomized into 2 treatment arms to receive VISPO or placebo in1:1 ratio.The subject will arrive at the study site in a fasting stateand blood samples will be collected for laboratory assessment . Post blood sample collection, subjects will undergo uroflowmetry assessments. The study will be conducted in 3 visits over a period of 84 days

Recruitment & Eligibility

Inclusion Criteria

1.Subjects with normal BMI of 18.5-24.9 kg/m2 2.Subjects who have no evidence of any underlying disease 3.Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test.
4.Must be willing and able to give informed consent and comply with the study procedures.

Exclusion Criteria

1.Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart, thyroid and liver disease) requiring medical treatment 2.History of Chronic metabolic disease.Psychiatric illness,Drug abuse, smoking, abuse/addiction to alcohol,Eating disorder such as bulimia or binge eating,Endocrine abnormalities including stable thyroid disease,Cardiovascular surgery / History of any major surgery 3.Subjects allergic to herbal products 4.Known HIV or Hepatitis B positive or any other immuno-compromised state 5.Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subjectâ€™s safety and preclude trial participation.
6.Currently participating or having participated in another clinical trial during the last 1 month prior to the beginning of this study 7.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.

Primary Outcome Measures

Name	Time	Method
Changes in Uroflowmetry parameters and laboratory parameters	Day 0, Day 42, Day 84

Secondary Outcome Measures

Name	Time	Method
overall safety assessment	Day 0, Day 42, Day 84

Locations (1): BGS Global Institute of Medical sciences
🇮🇳
Bangalore, KARNATAKA, India
BGS Global Institute of Medical sciences
🇮🇳Bangalore, KARNATAKA, India
Dr Jayashree S Seeri
Principal investigator
9482164779
drjayashree.ct@gmail.com