None listed
Conditions
Interventions
Intervention1: VISPO: Oral administration of single dose of VISPO capsules everyday for 84 days
Control Intervention1: Placebo: Oral administration of single dose of Placebo capsules everyday for 84 d
Sponsors
Vidya Herbs Pvt Ltd
Eligibility
Inclusion criteria
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
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 subjectââ?¬•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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Uroflowmetry parameters and laboratory parametersTimepoint: Day 0, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| overall safety assessmentTimepoint: Day 0, Day 42, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed