A clinical study to evaluate the safety and efficacy of formulations in subjects having benign prostate hyperplasia

Completed

Conditions: Having benign prostate hyperplasia

Registration Number: CTRI/2018/12/016724

Lead Sponsor: Vidya Herbs Private Limited

Brief Summary: This is a double blind, randomized (1:1:1), placebo controlled, parallel group, three arm, single center study. Elderly male subjects meeting all inclusion and no exclusion criteria after signing a written informed consent will be enrolled in the study.After passing the eligibility criteria, subjects will be randomized into 3 treatment arms to receive VISPO or SPO or placebo ) in 1:1:1 ratio. The study is planned to be conducted in 3 visits over a period of 12 weeks.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 99

Inclusion Criteria

At screening, subject has a 1IPSS > 7 2AMS score â‰¥ 27 3ADAM questionnaire items 1 or 7 or any other questions as positive 4Must be willing and able to give informed consent and comply with the study procedures.

Exclusion Criteria

1Has a history of prostate cancer or carcinoma of the prostate or, 2Subjects with known history of serum PSA concentration > 4 ng/ml must have prostate cancer ruled out to the satisfaction of the investigator.
3Has a residual void volume > 250 mL 4History of Neurogenic bladder dysfunction, Has bladder neck contracture or urethral stricture,Has acute or chronic prostatitis or urinary tract infection, Serious medical co-morbidity, Haematuria diabetes; any prior surgery which could induce dysuria, Use of any other herbal medications for treatment of BPH, associated symptoms and Erectile Dysfunction in past 1 month,Diuretics or drugs with antiandrogenic or alpha-receptor properties in the preceding 3 months.
5Subjects allergic to herbal products or any component of the study product 6Known HIV or Hepatitis B positive or any other immuno-compromised state 7Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 8Any 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
Change in the following parameter from baseline to end of treatment	Day 0, Day 42, Day 84
1.Post-voidal residual volume of urine	Day 0, Day 42, Day 84
2.IPSS score	Day 0, Day 42, Day 84
3. ADAM questionnaire score	Day 0, Day 42, Day 84
4.AMS score	Day 0, Day 42, Day 84

Secondary Outcome Measures

Name	Time	Method
Change in	1.Uroflowmetry parameters

Trial Locations

Locations (1): Aman Hospital and Research Center
🇮🇳
Vadodara, GUJARAT, India
Aman Hospital and Research Center
🇮🇳Vadodara, GUJARAT, India
Dr Aman Khanna
Principal investigator
amankhanna11974@gmail.com