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

Not Applicable

• Registration Number: CTRI/2021/12/038621
• Lead Sponsor: Vidya Herbs Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
overall safety assessmentTimepoint: Day 0, Day 42, Day 84