A clinical study to asses the efficacy and safety of JACKPROTM

Not yet recruiting

Conditions: Benign prostatic hyperplasia,

Registration Number: CTRI/2022/02/039901

Lead Sponsor: Vidya Herbs Pvt Ltd

Brief Summary: Thisis a double blind, randomized (1:1), placebo controlled, parallel group, twoarm, single center study. Elderly male subjects meeting all inclusion and noexclusion criteria after signing a written informed consent will be enrolled inthe study. After passing the eligibility criteria, subjects will be randomizedinto 2 treatment arms to receive JACKPROTM or placebo in 1:1 ratio.Thesubject will arrive at the study site in a fasting state and blood samples willbe collected for laboratory assessment and questionnaire based assessments will be performed.Thestudy is planned to be conducted in 3 visits over a period of 12 weeks.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Male

Target Recruitment: 70

Inclusion Criteria

1.At screening, subject has IPSS score greater than 7,AMS score greater than 27 and ADAM questionnaire items 1 or 7 or any 3 other questions as positive 2.Must be willing and able to give informed consent and comply with the study procedures.

Exclusion Criteria

1.Has a history of prostate cancer or carcinoma of the prostate or Subjects with known history of serum PSA concentration greater than 4 ng/ml must have prostate cancer ruled out to the satisfaction of the investigator.
2.Has a residual void volume greater than 250 mL 3.History of Neurogenic bladder dysfunction or bladder neck contracture or urethral stricture r acute or chronic prostatitis or urinary tract infection or Serious medical co-morbidity including Haematuria diabetes,any prior surgery which could induce dysuria, Use of any other herbal medications for treatment of BPH,or associated symptoms and Erectile Dysfunction in past 1 month or Diuretics or drugs with antiandrogenic or alpha-receptor properties in the preceding 3 months 4.Subjects allergic to herbal products or any component of the study product 5.Known HIV or Hepatitis B positive or any other immuno-compromised state 6.Currently participating or having participated in another clinical trial during the last 3 months 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
Mean Change in Post-voidal residual volume of urine and change in Questionnaire based assessments	Day 0, Day 42, Day 84

Secondary Outcome Measures

Name	Time	Method
Mean change in uroflowmetry parameters	Day 0, Day 84
Mean change in the male hormonal markers	Day 0, Day 84
Mean change in Quality of Life Questionnaire	Day 0, Day 42, Day 84

Trial Locations

Locations (1): BGS Global Institute of Medical sciences
🇮🇳
Bangalore, KARNATAKA, India
BGS Global Institute of Medical sciences
🇮🇳Bangalore, KARNATAKA, India
Dr M E Mohan
Principal investigator
9482164779
drmohanbgsresearch@gmail.com