| CTRI Number |
CTRI/2018/12/016724 [Registered on: 19/12/2018] Trial Registered Prospectively |
| Last Modified On: |
17/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the safety and efficacy of formulations in subjects having benign prostate hyperplasia |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled, parallel-group, single center clinical study to evaluate the efficacy and safety of VISPO in comparison with SPO and placebo in the treatment of benign prostate hyperplasia and male menopause |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aman Khanna |
| Designation |
Principal Investigator |
| Affiliation |
Aman Hospital and Research Centre |
| Address |
Room No:1,Department of general medicine,Aman Hospital and Research Centre Pvt Ltd. 15 Shaswat opposite ESI Hospital
Vadodara
GUJARAT
390021
India |
| Phone |
|
| Fax |
|
| Email |
amankhanna11974@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt.Ltd |
| Address |
No 9 , Myhthri Legacy Ist Floor Chelekere Main Road Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt.Ltd |
| Address |
No 9 , Myhthri Legacy Ist Floor Chelekere Main Road Kalyan Nagar
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidya Herbs (P) Ltd,No. 10, 33rd Main, 16th Cross,JP Nagar, 6th Phase, Bangalore – 560 078 |
|
|
Primary Sponsor
|
| Name |
Vidya Herbs Private Limited |
| Address |
No. 10, 33rd Main, 16th Cross,JP Nagar, 6th Phase, Bangalore – 560 078 |
| Type of Sponsor |
Other [Manufactureres of natural plant based food ingredients and Nutraceutical ingredients ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aman Khanna |
Aman Hospital and Research Center |
Room No: 1, Department of General medicine, 15 Shaswat opposite ESI Hospital
Vadodara
GUJARAT |
990402122
amankhanna11974@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aman Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Having benign prostate hyperplasia |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
500 mg capsule, twice a day ( morning and evening) orally for 84 days |
| Comparator Agent |
SPO
|
500 mg capsule containing 200 mg of SPO, twice a day ( morning and evening) orally for 84 days |
| Intervention |
VISPO |
500 mg capsule containing 200 mg of VISPO, twice a day ( morning and evening) orally for 84 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
At screening, subject has a
1 IPSS > 7
2 AMS score ≥ 27
3 ADAM questionnaire items 1 or 7 or any other questions as positive
4 Must be willing and able to give informed consent and comply with the study procedures
|
|
| ExclusionCriteria |
| Details |
1 Has a history of prostate cancer or carcinoma of the prostate or,
2 Subjects with known history of serum PSA concentration > 4 ng/ml must have prostate cancer ruled out to the satisfaction of the investigator.
3 Has a residual void volume > 250 mL
4 History 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.
5 Subjects allergic to herbal products or any component of the study product
6 Known HIV or Hepatitis B positive or any other immuno-compromised state
7 Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
8 Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the following parameter from baseline to end of treatment
1.Post-voidal residual volume of urine
2.IPSS score
3. ADAM questionnaire score
4.AMS score
|
Day 0, Day 42, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in
1.Uroflowmetry parameters
2.Biomarkers
3.Safety Parameters
4.Quality of Life Score |
Day 0, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
Final Enrollment numbers achieved (Total)= "99"
Final Enrollment numbers achieved (India)="99" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2018 |
| Date of Study Completion (India) |
16/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
"None yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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.
|