EFFECT OF KANDO OIL ON PREMATURE EJACULATIO

Phase 3

Recruiting

• Conditions: premature ejaculation.; The inability to control ejaculation sufficiently for both partners to enjoy sexual interaction

• Registration Number: IRCT2016122931645N1
• Lead Sponsor: trita company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 76

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
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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Ejaculation. Timepoint: before & 3 weeks after intervention. Method of measurement: PEDT qustioner - chornometer.

Secondary Outcome Measures

Name	Time	Method
Sexuall desire. Timepoint: before & 3 weeks after intervention. Method of measurement: IEEF qustioner.