UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023070 |
|---|---|
| Receipt number | R000026592 |
| Scientific Title | Evaluation of efficacy and safety profiles of tribulus terristrus in males with partial androgen deficiency and erectile dysfunction and lower urinary tract symptoms in a placebo controlled study |
| Date of disclosure of the study information | 2016/07/08 |
| Last modified on | 2018/04/12 16:44:09 |
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Basic information
Public title
Evaluation of efficacy and safety profiles of tribulus terristrus in males with partial androgen deficiency and erectile dysfunction and lower urinary tract symptoms in a placebo controlled study
Acronym
Safety and efficacy of tribulus terristrus in PADAM patients with erectile dysfunction and LUTS in a placebo controlled study
Scientific Title
Evaluation of efficacy and safety profiles of tribulus terristrus in males with partial androgen deficiency and erectile dysfunction and lower urinary tract symptoms in a placebo controlled study
Scientific Title:Acronym
Safety and efficacy of tribulus terristrus in PADAM patients with erectile dysfunction and LUTS in a placebo controlled study
Region
| Africa |
Condition
Condition
partial androgen deficiency with erectile dysfunction and low libido
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
potential roles of mesterolone and tribulus terristrus in PADAM patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Not yet available as the study is pre-intiating
Key secondary outcomes
Not yet available as the study is pre-intiating
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
one group of the PADAM patients will recieve placebo 3 times daily for 3 months with follow up of PSA / liver enzymes/ testosterone/ international prostate symptoms score (IPSS)/ validated Arabic version of international index of erectile function (IIEF)
Interventions/Control_2
one group of the PADAM patients will recieve tribulus terristrus 3 times daily for 3 months with follow up of PSA / liver enzymes/ testosterone/ international prostate symptoms score (IPSS)/ validated Arabic version ofinternational index of erectile function (IIEF)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 72 | years-old | >= |
Gender
Male
Key inclusion criteria
PADAM patients with erectile dysfunction and
lower urinary tract symptoms
Key exclusion criteria
1)PADAM patients without erectile dysfunction and low libido
2)PADAM patients with major systemic illness, smoking, drug addict, alcohol abuse
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | sameh fayek |
Organization
cairo university
Division name
Andrology & STDs
Zip code
Address
Al-Saray Street, El Manial Cairo-11956-Egypt
TEL
01227109309
samehfayek@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sameh Fayek |
Organization
Cairo University
Division name
Andrology department
Zip code
Address
Al-Saray Street, El Manial Cairo-11956-Egypt
TEL
01227109309
Homepage URL
http://scholar.cu.edu.eg/sfayek/
samehfayek@kasralainy.edu.cu.eg
Sponsor or person
Institute
cairo university
Institute
Department
Personal name
Funding Source
Organization
cairo university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 29 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 29 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 08 | Day |
Last modified on
| 2018 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026592
