CTRI/2024/06/068939尚未招募Unknown
A Prospective Interventional Open label Single-centre Single arm Study to Evaluate the Efficacy and Safety of CoQ10 Capsules in Subject suffering with Oligospermia - NI
M/s Synthite Industries Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Male participants aged 18 to 50 years
- •2 Diagnosis of oligospermia, confirmed by semen analysis showing a sperm concentration of less than 15 million sperm per milliliter or through medical history of the subjects
- •3 Willingness to provide informed consent to participate in the study
- •4 Ability to comply with the study protocol including attending study visits and completing study-related assessments.
- •5 Stable sexual partner or intention to engage in heterosexual intercourse for the duration of the study
- •6 Willingness to refrain from using other fertility treatments or supplements during the study period
- •7 Adequate understanding of the study procedures and willingness to follow the investigators instructions
排除标准
- •1. History and drug alcohol abuse smoking
- •2. BMI greater than 30 kg per m2
- •3. History of cancer chemotherapy
- •4. History of significant medical conditions that could affect fertility or interfere with study participation including severe cardiovascular disease uncontrolled hypertension renal failure liver disease or malignancy
- •5. Contraindication for the use of CoQ10
- •6. Genital disease (cryptorchidism current genital inflammation or varicocele)
- •7. Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) related illness and or known history of Hepatitis B virus (HBV) defined by presence of hepatitis B surface antigen (HBsAg) and or known history of Hepatitis C virus (HCV) defined by presence of hepatitis C antibody (HCVAb)
- •8. Genital trauma or surgery to the reproductive system
- •9. Hepatobiliary disease
- •10. Significant renal insufficiency
- •11. Occupational exposures to reproductive toxins
- •12. Endocrine abnormality
- •13. Recent or current sexually transmitted infection
- •14. Use of cytotoxic drugs
- •15. Use of immunosuppressants
- •16. Clinically relevant systemic disease (e g Insulin dependent diabetes adrenal dysfunction organic intracranial lesion, or hypothalamic tumor) or serious illness (Neoplasia)
- •17. Daunorubicin, Doxorubicin, Blood Pressure Medications Warfarin Timolol atorvastatin cerivastatin lovastatin pravastatin simvastatin gemfibrozil tricyclic antidepressant medications (including amitriptyline amoxapine clomipramine desipramine doxepin imipramine nortriptyline protriptyline and trimipramine) multivitamins or any vitamin supplementation except Folic acid
- •18.Use of anticonvulsants
- •19.Use of androgens or antiandrogens
- •20.History of central nervous system injury
- •21.Neurological or psychiatric disease to potentially compromise study data collection.
- •22.Abnormal COH screening blood done for both partners, including prolactin thyroid stimulating hormone prior to participation in study
- •23Treatment of erectile dysfunction with any drugs during the past 4 weeks
- •24 Current supplementation with ingredients being tested unless 1month washout period
研究者
相似试验
尚未招募
Unknown
To check the Efficacy and Safety of Gymne Mag D Capsules in patients with Type 2 Diabetes MellitusCTRI/2024/06/068889M/s Synthite Industries Private Limited
尚未招募
Unknown
To see the Efficacy and Safety of ProPlus Capsules in patients with Benign Prostatic Hyperplasia (BPH)CTRI/2024/06/068991M/s Synthite Industries Private Limited
尚未招募
Unknown
To check the Efficacy and Safety of Ashwagandha DSTR Capsule in patients with Moderate Stress Mild Anxiety Depression Low Stamina and StrengthCTRI/2024/06/069402M/s Synthite Industries Private Limited
进行中（未招募）
1 期
Prospective, interventional, open-label single center pilot study to evaluate FERInject Efficacy in 20 maintenance kidney transplant recipients.This study is aimed at kidney transplant recipient with chronic kidney disease, iron deficiency and anemia.MedDRA version: 21.1Level: LLTClassification code 10050308Term: Iron replacementSystem Organ Class: 100000004865EUCTR2020-002956-20-ITFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE20
已完成
不适用
efficacy and safety ofSilverNovaTM Skin Cream in Post aesthetic skin procedures subjects.CTRI/2022/07/043752Viridis BioPharma Pvt Ltd60