Objective: This study examined the qualitative and quantitative impact of this natural product on patients with premature ejaculation and it provided production requirements. Study design: randomized, triple-blind, placebo-controlled, stage three clinical trials study. Population: the men married more than six months and they are not satisfied from the time of ejaculation. Sample size: 76. Interventions: prescription of drug and placebo locally on penis and scrotum and perineum area.. Intervention time: every night before going to bed half-hour before intercourse. Primary outcome study of quantitative and qualitative improvement of premature ejaculation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122931645N1
Registration date:2017-01-13, 1395/10/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-13, 1395/10/24
Registrant information
Name
Seyedhamed Moosaviasil
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3376 5379
Email address
h-moosaviasil@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
traditional medicine faculty of Tehran university of medical scince
Expected recruitment start date
2017-01-04, 1395/10/15
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of local traditional medicine product based on Nigella Sativa on premature ejaculation
-A ranomized triple blind placebo controlled traial
Public title
EFFECT OF "KANDO OIL" ON PREMATURE EJACULATION
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. The men 20 to 40 years old.
2. Steady sexual activity at least 6 month with a female partner.
3. The history of premature ejaculation more than 6 months.
4. Time IELT less than 1 minute.
5. The ability to begin and maintain an erection (IIEF score of 22).
6. Sexual intercourse at least one time per week.
7. Informed consent of patient to entering the project and filling the consent form from him.
None Inclusion criteria:
1. A history of severe organic diseases such as uncontrolled diabetes, heart failure, acute renal failure, urinary surgery, urinary tract infections in male and partner.
2. A history of severe psychiatric illness and poor mental state.
3. PEDT questionnaire score less than 11.
4. The history of alternate premature ejaculation.
5. Erectile Dysfunction (IIEF score less than 22)
6. Anatomic abnormalities of the penis that causes unsuccessful penetration.
7. Substance abuse such as alcohol, opium and smoking.
8. Using drugs that affect the sexual function, including phosphodiesterase inhibitors and selective serotonin reuptake inhibitors and opioids and antidepressants and anti-anxieties and hormonal drugs during project.
9. Extreme hot and dry temperament.
10. The warm and wet temperament with semen acuity.
11. Any history of hypersensitivity to black cumin, frankincense and olives.
12. The history of any type of mucosal and dermal allergy.
Exclusion criteria:
1. using of drugs and substance that effective on sexual performance.
2. Intercourse activity less than twice in three weeks.
3. The using of condom and local anesthetic.
4. The sever decrease in male libido or sexual partner.
5. The use of any vaginally cream, ointment or gel by partner.
6. Severe and intolerable adverse events associated with the drug based on a questionnaire PRO- CTCAE.
7. The Withdrawing of participant from continuing the project with any reason.
Age
From 75 years old to 55 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
tehran university of medical scinse
Street address
Tehran, Keshavarz Blvd. and Ghods Crossroads, Tehran University of Medical Sciences Headquarters Building, fifth floor, Room 501
City
tehran
Postal code
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1315
Health conditions studied
1
Description of health condition studied
premature ejaculation
ICD-10 code
F52.4
ICD-10 code description
The inability to control ejaculation sufficiently for both partners to enjoy sexual interaction
Primary outcomes
1
Description
Time to Ejaculation
Timepoint
before & 3 weeks after intervention
Method of measurement
PEDT qustioner - chornometer
Secondary outcomes
1
Description
sexuall desire
Timepoint
before & 3 weeks after intervention
Method of measurement
IEEF qustioner
Intervention groups
1
Description
The placebo prescripted for once every night and halfhour before sexual intercourse for 3 weeks. For anytime placebo used locally two puffs (each puff about 25/0 cc) on the penis and two puffs scrotum and two puffs perineal area.
Category
Treatment - Drugs
2
Description
The drug prescripted for once every night and halfhour before sexual intercourse for 3 weeks. For anytime drug used locally two puffs (each puff about 25/0 cc) on the penis and two puffs scrotum and two puffs perineal area.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
traditional medicine clinic
Full name of responsible person
syed hamed moosaviasil
Street address
Enghelab st.-college bridge- Khark st.-near the court
City
tehran
2
Recruitment center
Name of recruitment center
urology clinic of sina hospital
Full name of responsible person
Street address
City
tehran
3
Recruitment center
Name of recruitment center
ahmadiyh clinic
Full name of responsible person
Street address
City
tehran
4
Recruitment center
Name of recruitment center
toba clinic
Full name of responsible person
Street address
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
trita company
Full name of responsible person
mohammad mahdi ahmadianattary
Street address
alborz yniversity of medical scinse
City
karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
trita company
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
tradiional medicine faculty of TUMS
Full name of responsible person
mysam shirzad
Street address
tradiional medicine faculty of TUMS
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?