| CTRI Number |
CTRI/2013/10/004065 [Registered on: 15/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
03/10/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
This study is to see the safety tolerability and efficacy of study medication (Dose I & II) compared to placebo in subjects with Benign Prostatic Hyperplasia |
|
Scientific Title of Study
|
An exploratory double-blind placebo controlled randomized parallel group multi-centric study to evaluate the safety tolerability and efficacy of LinumLife EXTRA (Dose I & II) compared to placebo in subjects with Benign Prostatic Hyperplasia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VL/0702174/FR, Version 1.3, Date: 16-07-2008 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Navneet Sonawane |
| Designation |
Trial Coordinator |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt. Ltd.
118 Morya House, Off Link Road,
Andheri (W), Mumbai-400053
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02242025706 |
| Fax |
|
| Email |
navneet.s@vediclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navneet Sonawane |
| Designation |
Trial Coordinator |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt. Ltd.
118 Morya House, Off Link Road,
Andheri (W), Mumbai-400053
MAHARASHTRA
400053
India |
| Phone |
02242025706 |
| Fax |
|
| Email |
navneet.s@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navneet Sonawane |
| Designation |
Trial Coordinator |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt. Ltd.
118 Morya House, Off Link Road,
Andheri (W), Mumbai-400053
MAHARASHTRA
400053
India |
| Phone |
02242025706 |
| Fax |
|
| Email |
navneet.s@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Frutarom Netherlands BV, Landjuweel 5, 3905 PE Veenendaal, The Netherlands.
|
|
|
Primary Sponsor
|
| Name |
Frutarom Netherlands BV |
| Address |
Landjuweel 5
3905 PE Veenendaal
The Netherlands
|
| Type of Sponsor |
Other [Nutraceutical Industry - Global] |
|
|
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 Mukund G Andankar |
B.Y.L.Nair charitable Hospital and Topiwala Medical College |
Dr.A.L.Nair Road,
Mumbai – 400 008.
Mumbai
MAHARASHTRA |
022-22067676
mukundandankar@gmail.com |
| Dr Umesh Khanna |
Lancelot Kidney and GI Centre |
111/C, Lancelot, S.V.Road, Borivli (West),
Mumbai – 400 062
Mumbai
MAHARASHTRA |
022-28016266
ubkhanna@gmail.com |
| Dr Chetan Patil |
Muktai Hospital |
Plot no. 11, Opp. Fame Adlaboratorys,
Shivaji Nagar, Nasik-Pune Road,
Nasik – 422 006.
Nashik
MAHARASHTRA |
9822651494
patilchetan@yahoo.com |
| Dr Milind Bapat |
Sardesai Clinic |
Shymala Apartment,
968/3, Senapati Bapat Road, Pune- 411016
Pune
MAHARASHTRA |
020-25655665
milindbbapat@yahoo.co.in |
| Dr Raju Uttamani |
Shraddha Hospital |
Shraddha Hospital and ICU, Dept of Surgery,
Hospital Road,
Ulhasnagar – 421 003
Thane
MAHARASHTRA |
9822078819
rbuttamani@gmail.com |
| Dr Rajesh Shrotri |
Shrotri Urology Hospital |
24, Parvati Darshan, Velankar Nagar,
Indira Bungalow, Near Laxminarayan Theatre,
Pune- 411 009.
Pune
MAHARASHTRA |
9822063622
rajesh.shrotri@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee, B.Y.L NAIR CH Hospital Mumbai - Dr. Mukund Andankar |
Approved |
| Independent Ethics Committee Mumbai - Dr. Chetan Patil |
Approved |
| Independent Ethics Committee Mumbai - Dr. Milind Bapat |
Approved |
| Independent Ethics Committee Mumbai - Dr. Rajesh Shrotri |
Approved |
| Independent Ethics Committee Mumbai - Dr. Raju Uttamani |
Approved |
| Independent Ethics Committee Mumbai - Dr. Umesh Khanna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Benign Prostatic Hyperplasia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Carboxy Methyl Cellulose - Placebo |
500mg capsule in the morning daily for 8 weeks |
| Intervention |
LinumLife Extra - Investigational product |
500mg capsule in the morning daily for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
• Ages eligible for Study : 45 Years - 75 Years
• Genders eligible for Study : Male
• Newly diagnosed cases of BPH (i.e. Fresh cases) diagnosed by USG along with documented symptoms of BPH (frequency; urgency; night time urination; reduced flow etc)
• American Urological Association (AUA) Symptom Index Score ≥ 13.
• PSA equal to or less than 4 ng/mL ( 0 to ≤ 4 ng/ml)
• Residual urine volume > 30 ml to <200 ml post voiding
|
|
| ExclusionCriteria |
| Details |
Subjects on 5 –alpha reductase inhibitors. Subjects on alpha 1 adrenergic antagonist (alpha blockers.
Subjects on combination of 5 –alpha reductase inhibitors and alpha-blockers(K/c/o BPH on medications)
Subjects on anti-cholinergics
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Change in the American Urological Symptom Index Score |
Baseline to end of treatment (Day 56). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Change in the Post Voiding Residual Urine volume in all treatment groups |
Baseline to end of treatment (Day 56). |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/01/2008 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Benign Prostatic
Hyperplasia (BPH) is associated with
bothersome lower urinary tract symptoms (LUTS) that affect quality of life by
interfering with normal daily activities and sleep patterns. The prevalence of
bothersome symptoms also increases with age. Treatment of BPH is
currently undergoing intense scrutiny due to the cost and morbidity
{complications and disability due to the procedure associated with the “gold
standard†treatment, Transurethral Resection of the Prostate (TURP)} but this along with bladder neck incision are
costly and have adverse effects including bleeding, infection and sexual
dysfunction such as retrograde ejaculation, and
may not be required in less severe cases. Hence it is
the need of time to look out for oral medications for BPH with minimal side
effects. There is a need to develop other treatments, especially for subjects
unfit for surgery or with less severe symptoms. The
modern drugs do provide symptomatic relief to the patient, which is the most
important target to be achieved in these subjects. In the present study, the
aim is to assess these formulations as a supportive therapy for symptoms of BPH
and at the same time to determine their efficacy. In this study we are trying
to evaluate these herbal formulations and monitor whether the Investigational
Product (IP) LinumLife Extra (two active doses) can maintain and further
provide greater symptomatic relief to subjects with BPH |