An Open Label, Prospective, Non- Comparative Single Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Boostex Forte capsule in Erectile dysfunction, Premature Ejaculation and associated conditions in Adult Males.

SG Phyto Pharma Private Limited0 个研究点目标入组 80 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Adult males aged between 25 and 60 years (both ages inclusive) with known history or complaint of sexual dysfunction not limited to
•- Erectile Insufficiency
•- Premature Ejaculation
•- Ability to achieve and maintain erection
•- Psychic Functional Impotency
•- Decreased Libido
•- History of decreased/insufficient sperm count, motility and health.
•2. Subjects who are in a monogamous, heterosexual relationship
•3. Subjects with or without children.
•4. Subjects who have scored a total of lesser than equal to on the International Index of Erectile Function Domain A at the time of screening
•5. Subject or LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
•6. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
•7. Subjects who are willing to give all forms of medications or therapies for sexual dysfunction â?? oral, topical etc for the duration of the clinical study.

•1. Subjects with known hypersensitivity to herbal investigational product or its constituents.
•2. Subjects with current or chronic infection not limited to urinary tract infection, chronic renal infection.
•3. Subjects on medications or herbal supplements for sexual dysfunction.
•4. Subjects with hypogonadism or anatomical deformities of the penis such as severe penile fibrosis or Peyronie disease or phimosis.
•5. Subjects who are currently on medications that are known to cause sexual dysfunction- cimetidine, spironolactone, thiazides, adrenergic blockers, anti- depressants etc
•6. Subjects with immunucompromised state complications.
•7. Subjects with uncontrolled diabetes, hypertension or congestive heart failure.
•8. Any significant medical condition e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc. , any medical condition that is unstable or poorly controlled or other factor e.g., planned relocation that the Investigator felt would interfere with study evaluations and study participation.
•9. Subjects who have participated in any clinical study within 3 months from the date of enrolment.
•10. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
•11. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study

发起方

SG Phyto Pharma Private Limited