This randomized double-blind clinical trial was conducted to comparison the effects of three herbal drugs including Equisetum arvense , Urtica diociea and Sedlitzia rosmarinus on clinical symptoms of Benign Prostatic Hyperplasia . The number of 620 Subjects selected from new BPH cases referred to Shohadaye Ashayer urology clinic and did not have history of prostate cancer ,CRF, DM and CHF. After convenience campling, by randimozed block design subjects were allocated to four group including Equisetum arvense plus prazosin (n=186), Urtica diociea plus prazosin (n=186) and Sedlitzia rosmarinus plus prazosin (n=186) and only prazosin as control group(n=62). The subjects of each group allocated again to three group of 3gr/day, 5 gr/day and 7 gr/day. The subject were advised to take the prescribed herbal drug one time daily for two months. Before and After 2 months of intervention by AUA questionnaire storage and voiding clinical symptoms and serum PSA of patients were measured.
The scores of clinical symptoms and serum PSA of each group were compared before and after the intervention. The mean recovery scores of clinical symptoms and serum PSA of subjects in all group were compared after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208279302N2
Registration date:2012-09-22, 1391/07/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-22, 1391/07/01
Registrant information
Name
Reza Hosseinabadi
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1620 0140
Email address
reza.hosseinabadi@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-01-09, 1391/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Equisetum arvense , Urtica diociea and Sedlitzia rosmarinus effects on clinical symptoms of Benign Prostatic Hyperplasia
Public title
Effect of herbal Drugs on Benign prostatic hyperplasia symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age of 49 and above; New BPH diagnosed cases; To have storage or voiding symptoms; AUA score of 7 and above; Urine Bacterial count less than 100000/ml; Serum ceartinine less than 1.5 mg/dl; PSA less than 4 n/ml
Exclusion criteria: To have history of prostate cancer; To have prostatitis; Neurogenic blader cases; To have Diabetes mellitus; To have Nephropathy; To have CHF; To have Renal failure; To have more than two antihypertensive drugs; To have non prescriptive herbal drugs;
Age
From 49 years old to 85 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
620
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethice committee of Lorestan University of Medical Sciences
Street address
Kamalvand, Khorramabad, Iran
City
Khorramabad
Postal code
Approval date
2012-07-14, 1391/04/24
Ethics committee reference number
200/70670
Health conditions studied
1
Description of health condition studied
Benign Hypertrophy of prostate
ICD-10 code
N40
ICD-10 code description
Hypertrophy (benign)) of prostate
Primary outcomes
1
Description
storage or voiding clinical symptoms
Timepoint
Before and 2 months after the intervention
Method of measurement
AUA Questionnaire
Secondary outcomes
1
Description
Serum PSA
Timepoint
Before and 2 months after the intervention
Method of measurement
Blood laboratory test
Intervention groups
1
Description
The Seidlitzia rosmarinus group3 (n=62): Seidlitzia rosmarinus 3 gr/day plus perazisin at 1 mg daily for two months
Category
Treatment - Drugs
2
Description
The Urtica diociea group3 (n=62): Urtica diociea 3 gr/day plus perazisin at 1 mg daily for two months
Category
Treatment - Drugs
3
Description
The Seidlitzia rosmarinus group5 (n=62): Seidlitzia rosmarinus 5 gr/day plus perazisin at 1 mg daily for two months
Category
Treatment - Drugs
4
Description
The Equisetum arvense group7 (n=62): Equisetum arvense 7 gr/day plus perazisin at 1 mg daily for two months
Category
Treatment - Drugs
5
Description
The Urtica diociea group5 (n=62): Urtica diociea 5 gr/day plus perazisin at 1 mg daily for two months
Category
Treatment - Drugs
6
Description
The Urtica diociea group7 (n=62): Urtica diociea 7 gr/day plus perazisin at 1 mg daily for two months
Category
Treatment - Drugs
7
Description
The Equisetum arvense group3 (n=62): Equisetum arvense3 gr/day plus perazisin at 1 mg daily for two months
Category
Treatment - Drugs
8
Description
The Equisetum arvense group5 (n=62): Equisetum arvense 5 gr/day plus perazisin at 1 mg daily for two months
Category
Treatment - Drugs
9
Description
The Seidlitzia rosmarinus group7(n=62): Seidlitzia rosmarinus 7 gr/day plus perazisin at 1 mg daily for two months
Category
Treatment - Drugs
10
Description
The control group(n= 62): only perazisin at 1 mg daily for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Ashayer Urology Clinic
Full name of responsible person
Mohammad Heydari
Street address
Enghelab Street,Shohadaye Ashayer Hospitals
City
Khorramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi Herbal Medicine Research Center of Lorestan University of Medical Sciences
Full name of responsible person
Bahram Rasoolian
Street address
Kmalvand, Khorramabad,Iran
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi Herbal Medicine Research Center of Lorestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences, School of Nursing & Midwifery
Full name of responsible person
Reza Hosseinabadi
Position
MSc in Nursing
Other areas of specialty/work
Street address
Kamalvand, Khorramabad, Iran
City
Khorramabad
Postal code
6819846531
Phone
+98 66 1620 0140
Fax
Email
reza_hosseinabadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences, School of Medicine
Full name of responsible person
Mohammad Heidari
Position
Professor of Urology
Other areas of specialty/work
Street address
Enghelab Street, Shohadaye Ashayer Hospitals
City
Khorramabad
Postal code
Phone
+98 66 1323 6401
Fax
Email
Mheydari2010@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences, School of Nursing & Midwifry
Full name of responsible person
Reza Hosseinabadi
Position
MSc in nursing
Other areas of specialty/work
Street address
Kmalvand, Khorramabad, Iran
City
Khorramabad
Postal code
6819848464
Phone
+98 66 1620 0140
Fax
Email
reza_hosseinabadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)