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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 5. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS): Patient Version: Total Score of greater than equal to 35
研究概览
简要总结
Study Design : An Open Label, Prospective, Non Comparative Single Arm Clinical Study.
Indication : Male Sexual Dysfunction (Erectile Dysfunction, Premature ejaculation, Decreased Libido)
Investigational Product : Boostex Forte
Comparator : None.
Dose/Dosage : 2 BID for 30 days
Subject Population : Adult males between 25 and 60 years of age with complaints of sexual dysfunction
Number of Subjects : 80 Evaluable Subject
Treatment Arms : Single Arm Study
Treatment Duration : 30 Days treatment duration. Post Treatment Telephonic Follow up on Day 45 and Day 60
Assessments 1. International Index of Erectile Function(IIEF) Domain A: Screening 2. Index of Premature Ejaculation: Day 1 and Day 30 3. Boostex Forte: Quality of LifeQuestionnaire: Day 1, Day 30, Day 45, Day 60 4. International Index of Erectile Function(IIEF) : Day 1, Day 30, Day 45, Day 60 5. Erectile Dysfunction Inventory ofTreatment Satisfaction (EDITS): Patient Version: Day 45, Day 60
Background of the study: Sexual dysfunction is a complex medical issue with biological, psychological and social influences and is estimated to be highly prevalent in the global population. Natural aphrodisiacs are being intensified as the potency of herbal plan drugs is significant without the cause for side effects.
Purpose of the study: Boostex Forte is a classic combination of herbo mineral ingredients which possess spermatogenic properties, promite vigour and increase libido and also improves mental and physical health that in turn boost sexual desire and support performance in men. This clinical study is designed to evaluate the safety and effectiveness of Boostex Forte Capsules in improving male sexual dysfunction
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •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.
- •Subjects who are in a monogamous, heterosexual relationship
- •Subjects with or without children.
- •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
- •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.
- •Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
- •Subjects who are willing to give all forms of medications or therapies for sexual dysfunction – oral, topical etc for the duration of the clinical study.
排除标准
- •Subjects with known hypersensitivity to herbal investigational product or its constituents.
- •Subjects with current or chronic infection not limited to urinary tract infection, chronic renal infection.
- •Subjects on medications or herbal supplements for sexual dysfunction.
- •Subjects with hypogonadism or anatomical deformities of the penis such as severe penile fibrosis or Peyronie disease or phimosis.
- •Subjects who are currently on medications that are known to cause sexual dysfunction- cimetidine, spironolactone, thiazides, adrenergic blockers, anti- depressants etc
- •Subjects with immunucompromised state complications.
- •Subjects with uncontrolled diabetes, hypertension or congestive heart failure.
- •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.
- •Subjects who have participated in any clinical study within 3 months from the date of enrolment.
- •Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
结局指标
主要结局
5. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS): Patient Version: Total Score of greater than equal to 35
时间窗: 1. International Index of Erectile Function (IIEF): Day 1, Day 30. | 2. Index of Premature Ejaculation: Day 1, Day 30. | 3. Boostex Forte: Quality of Life Questionnaire: Day 1, Day 30. Telephonic Day 45, Day 60 | 4. International Index of Erectile Function (IIEF) : Telephonic Day 45, Day 60 | 5. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS): Patient Version: Telephonic Day 45, Day 60
1. International Index of Erectile Function (IIEF): Total Score of greater than equal to 60.
时间窗: 1. International Index of Erectile Function (IIEF): Day 1, Day 30. | 2. Index of Premature Ejaculation: Day 1, Day 30. | 3. Boostex Forte: Quality of Life Questionnaire: Day 1, Day 30. Telephonic Day 45, Day 60 | 4. International Index of Erectile Function (IIEF) : Telephonic Day 45, Day 60 | 5. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS): Patient Version: Telephonic Day 45, Day 60
2. Index of Premature Ejaculation: Total Score of greater than equal to 35
时间窗: 1. International Index of Erectile Function (IIEF): Day 1, Day 30. | 2. Index of Premature Ejaculation: Day 1, Day 30. | 3. Boostex Forte: Quality of Life Questionnaire: Day 1, Day 30. Telephonic Day 45, Day 60 | 4. International Index of Erectile Function (IIEF) : Telephonic Day 45, Day 60 | 5. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS): Patient Version: Telephonic Day 45, Day 60
3. Boostex Forte: Quality of Life Questionnaire: Total Score of greater than equal to 10
时间窗: 1. International Index of Erectile Function (IIEF): Day 1, Day 30. | 2. Index of Premature Ejaculation: Day 1, Day 30. | 3. Boostex Forte: Quality of Life Questionnaire: Day 1, Day 30. Telephonic Day 45, Day 60 | 4. International Index of Erectile Function (IIEF) : Telephonic Day 45, Day 60 | 5. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS): Patient Version: Telephonic Day 45, Day 60
4. International Index of Erectile Function (IIEF) : Total Score of greater than equal to 60
时间窗: 1. International Index of Erectile Function (IIEF): Day 1, Day 30. | 2. Index of Premature Ejaculation: Day 1, Day 30. | 3. Boostex Forte: Quality of Life Questionnaire: Day 1, Day 30. Telephonic Day 45, Day 60 | 4. International Index of Erectile Function (IIEF) : Telephonic Day 45, Day 60 | 5. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS): Patient Version: Telephonic Day 45, Day 60
次要结局
未报告次要终点