| CTRI Number |
CTRI/2012/10/003049 [Registered on: 08/10/2012] Trial Registered Retrospectively |
| Last Modified On: |
15/07/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Safety and Efficacy of Capsule Outflo in Patients with Benign Prostatic Hyperplasia |
|
Scientific Title of Study
|
A Randomized Open Label Dose Determination Clinical Study to Evaluate the Safety and Efficacy of Capsule Outflo in Patients with Benign Prostatic Hyperplasia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS/SAH/01/2012, Version #1.0, Dated 30 July 2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shailesh A Shah |
| Designation |
Chairman |
| Affiliation |
Bodyline Hospitals |
| Address |
Nava Vikas Gruh Road,
Opp. Annapurna Hall,
Nr. Dev Status,Paldi,
Ahmedabad-380007,India
Ahmadabad
GUJARAT
380007
India |
| Phone |
079-26651520 |
| Fax |
079-26640558 |
| Email |
shaileshshahuro@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Dipak Patel |
| Designation |
R&D Manager |
| Affiliation |
Sahajanand Life Sciences Private Limited |
| Address |
Sahajanand Estate, Plot No. 53-57, Wakhariawadi, Near Dabholi Char-rasta, Ved Road,Surat-395009
Surat
GUJARAT
395004
India |
| Phone |
|
| Fax |
|
| Email |
dipak.patel@sahbio.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nirav Joshi |
| Designation |
Co-investigator |
| Affiliation |
Sahana Clinical Research |
| Address |
Sahana Clinical Research
101, Tirupati Chambers,
Sub-jail cross-roads,
Surat - 395 002
Surat
GUJARAT
395004
India |
| Phone |
9879839644 |
| Fax |
|
| Email |
nirav.joshi@sahanacro.com |
|
|
Source of Monetary or Material Support
|
| Sahajanand Life Sciences Private Limited |
|
|
Primary Sponsor
|
| Name |
Sahajanand Life Sciences Private Limited |
| Address |
Sahajanand Estate, Plot 53-57,
Wakhariawadi, Near Dabholi Char-rasta, Nani Ved, Ved Road,
Surat - 395004, Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailesh A Shah |
Bodyline Hospitals |
Department of Urology,
3rd Floor,
Nava Vikas Gruh Road, Opp. Annapurna Hall, Nr. Dev Status,Paldi,
Ahmadabad
GUJARAT |
079-26651520
shaileshshahuro@yahoo.com |
| Dr Gyanendra R Sharma |
Chitale Clinic |
Basement,165 D Railway Lines, Saat Rasta, Opposite Bus Stand, Solapur – 413001
Solapur
MAHARASHTRA |
0217-2319251
drgrsharma@hotmail.com |
| Dr Rasesh Desai |
Desai Uroligical and Maternity Hospital |
Urological Department,
2nd and 3rd Floor,
Abhinav Complex
Kamalkunj Society, Delux Circle,
Nizampura
Vadodara
GUJARAT |
9624062118
raseshdesai61@hotmail.com |
| Dr Vijay D Raghoji |
Dr. Raghoji Kidney Hospital and Research Centre |
Basement,
146/2 Railway Lines, Near Old R.T.O., Solapur
Solapur
MAHARASHTRA |
0217-2314911
drvdraghoji@gmail.com |
| Dr Ravindra B Sabnis |
Muljibhai Patel Urological Hospital |
Department of Urology,
Dr. Virendra Desai Road,
Nadiad 387001
Kheda
GUJARAT |
0268-2520323
rbsabnis@gmail.com |
| Dr Janak D Desai |
Samved Hospital |
Urology Department
2nd Floor,
Nr. Stadium circle, Navarangpura, Ahmedabad,
Ahmadabad
GUJARAT |
079-26420285
drjanakddesai@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| International Bio Industry Open-Innovation MovEment Independent Ethics Committee (IBIOME IEC)_Ahmedabad_Dr. Gyanendra Sharma |
Approved |
| International Bio Industry Open-Innovation MovEment Independent Ethics Committee (IBIOME IEC)_Ahmedabad_Dr. Janak Desai |
Approved |
| International Bio Industry Open-Innovation MovEment Independent Ethics Committee (IBIOME IEC)_Ahmedabad_Dr. Kapil Thakkar |
Approved |
| International Bio Industry Open-Innovation MovEment Independent Ethics Committee (IBIOME IEC)_Ahmedabad_Dr. Rasesh Desai |
Approved |
| International Bio Industry Open-Innovation MovEment Independent Ethics Committee (IBIOME IEC)_Ahmedabad_Dr. Shailesh A. Shah |
Approved |
| International Bio Industry Open-Innovation MovEment Independent Ethics Committee (IBIOME IEC)_Ahmedabad_Dr. Vijay Raghoji |
Approved |
| Muljibhai Patel Society for Research in Nephro-Urology Ethics Committee (MPSRNUEC) Affiliated to Muljibhai Patel Urological Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Benign Prostatic Hyperplasia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capsule Outflo (1 BD) |
Total duration of therapy 90 days.
Poly-herbal formulation containing
1. Boerhavia diffusa
2. Crateva nurvala
3. Tribulus terrestris
4. Curucma longa
5. Tinospora cordifolia
6. Saw palmetto |
| Intervention |
Capsule Outflo (2 BD) |
Total duration of therapy 90 days.
Poly-herbal formulation containing
1. Boerhavia diffusa
2. Crateva nurvala
3. Tribulus terrestris
4. Curucma longa
5. Tinospora cordifolia
6. Saw palmetto |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
•Male patients with aged ≥40
•New patients diagnosed with BPH, naïve to any other treatments for BPH
•Patients with International Prostate Symptom Score (IPSS) greater than 7 and less than 18
•Patients with Prostate volume less than 40 cc
•Patients with Qmax of 8-12 ml/sec
•Patients with PVUR less than 200 ml
•Patients willing to give written informed consent and willing to follow up
|
|
| ExclusionCriteria |
| Details |
•Patients with prostatic cancer; neurogenic bladder; bladder cancer; bladder stones; urethral strictures; neurological conditions that might interfere with normal voiding
•Symptomatic coronary arterial disease, stroke, and cardiovascular events
•Current treatment with systemic corticosteroids or herbal (alternative) medicines
•Patients with abnormal renal and hepatic function
•Any significant disease or disorder that may jeopardize the safety of the subject
•Patients with drug and alcohol abuse
•Any psychiatric disorder
•Patients who have participated in any clinical trial in the past 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in International Prostate Symptom Score (IPSS)
Change in Uroloflowmetry parameters |
Change in International Prostate Symptom Score (IPSS)(baseline - 1 month - 2 months - 3months)
Change in Uroflowmetry parameters (baseline - 1 month - 2 months - 3months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Prostate Volume |
Baseline - End of Study |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/09/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, open label, multi-centric trial comparing the safety and efficacy of Capsule OutFlo (1 BD) and OutFlo (2 BD) 75 patients with Benign Hyperplasia of Prostate. The primary outcome of the trial is to compare the decrease in IPSS in patients taking OutFlo (1BD) vs. OutFlo (2 BD) . Primary outcome measures would also include change in Qmax and post void residual urine volume. Reduction in Prostate size from the base-line to the end of the study would be noted as a secondary outcome measure. |