| CTRI Number |
CTRI/2009/091/000021 [Registered on: 29/01/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Other |
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Public Title of Study
|
A clinical trial to study the safety and efficacy of herbal medicine URAL- BPH in the treatment of Benign Prostate Hyperplasia. |
|
Scientific Title of Study
|
A multicentre, open label, clinical trial to study the efficacy and safety of URAL- BPH in the treatment of Benign Prostate Hyperplasia. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Sujata Patwardhan, Dr.Sanjay Swain |
| Designation |
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| Affiliation |
|
| Address |
L.T.M. Medical College
Building, 2nd floor, room no. 17, Sion
Mumbai
MAHARASHTRA
400 022
India |
| Phone |
91 0 9819075202 |
| Fax |
91 022 40022022 |
| Email |
sujata.patwardhan@rediffmail.com, ltmghurology@rediffmail.com,sanjayswain@rediffmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Aasin Kumar Maurya |
| Designation |
|
| Affiliation |
|
| Address |
Pace ClinServe Pvt. Ltd, 12 B, Nirmal
Nariman Point, Mumbai-400021, India.
Mumbai
MAHARASHTRA
400 022
India |
| Phone |
91 022 22821095 |
| Fax |
91 022 40022022 |
| Email |
amaurya@paceclinserve.com |
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Details of Contact Person
Public Query
|
| Name |
Mr. Bharat Shukla |
| Designation |
|
| Affiliation |
|
| Address |
12 B, Nirmal, Nariman Point
Mumbai India
Mumbai
MAHARASHTRA
400021
India |
| Phone |
91 022 22821095 |
| Fax |
91 022 40022022 |
| Email |
bshukla@paceclinserve.com |
|
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Source of Monetary or Material Support
|
| VASU HEALTHCARE PVT. LTD.
967/4, G. I. D. C. Makarpura,
Vadodara-390 010,
Gujarat, India.
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Primary Sponsor
|
| Name |
Pace ClinServe Pvt. Ltd,
12 B, Nirmal, Nariman Point
Mumbai-400021
India |
| Address |
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| Type of Sponsor |
|
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Harish |
Nair Hospital |
B.Y.L. Nair Charitable Hospital & Topiwala National Medical College, Dr.A.L.Nair Road,, Mumbai- 400 008. India -400008
|
91 0 9323342361
91 022 40022022
drharishkaswan@gmail.com |
| Dr.Ujjwal |
Sion Hospital |
Lokmanya Tilak Muncipal General Hospital & Medical College Sion,, Mumbai-400 022 India -400022
Mumbai
MAHARASHTRA |
91 0 9323946686
91 022 40022022
drujjwalbansal@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Nair Golden Jubliee Research Foundation, Nair Hospital |
Approved |
| SRS IEC, Sion Hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Benign Prostate Hyperplasia a nonmalignant enlargement of the prostate., |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
URAL-BPH |
Oral, one capsule, Twice a day 15 minutes before meals, 3 months
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1. Age 40 and above.
2. PSA 4 -10 ( free PSA will be calculated, free/Total PSA ratio shall be > 0.01. In case Free/Total PSA ratio is < 0.01, then biopsy shall be done to rule cancer. If the biopsy is negative for cancer then the patient will be included in the study)
3. BPH diagnosed by digital rectal exam (DRE)
4. Prostate size diagnosed by DRE >25ml
5. International Prostate Symptom Score (IPSS) > 9 and < 15 (Moderate 8-19)
6. Urinary flow between 5-10ml/sec (with a urine Volume at least 150ml, and a post-voiding residue of <200ml)
7. Good mental and physical condition
|
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| ExclusionCriteria |
| Details |
1. Excessively mild or severe symptoms of BPH including incontinence, Bladder distension,
2. Urine flow< 5mls/sec;
3. Bladder or prostate cancer
4. Previous prostate surgery
5. Previous radiotherapy
6. Serious medical co-morbidity
7. Urogenital infection prior treatment for BPH
8. Hematuria diabetes; any prior surgery which could induce dysuria
9. Use of any other herbal medications for treatment of BPH, associated symptoms and Erectile Dysfunction in past 1 month.
10. Diuretics or drugs with antiandrogenic or alpha-receptor properties in the preceding 3 months.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
| 1. IPSS (International Prostate Symptom Score) |
12 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1. DRE (Digital Rectal Examination).
2. Prostate volume (by DRE).
3. Urine flow.
4. Bladder residual volume.
5. IIEF (International Index of Erectile Function)
6. QOL ( Quality of Life).
7. Voiding Dairy.
8. Serum Creatinine and other safety assessment (AE/SAE/Lab investigation)
|
12 months |
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Target Sample Size
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Total Sample Size="0"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/10/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
1. This study is A multicentre, open label, clinical trial to study the efficacy and safety of herbal medicine URAL-BPH for 12 months in 30 patients with Benign Prostate Hyperplasia that will be conducted in two center in India. The primary outcome measures will be lower IPSS (International Prostate Symptom Score) and the secondary outcome will be DRE ( Digital Rectal Examination0, Prostate Volume (by DRE), Urine flow, Bladder residual volume, IIEF, QOL, Voiding dairy and Serum Creatinine and other safety Assessment ( AE/SAE/Lab investigation). |