CTRI/2023/05/053000招募中3 期
A prospective, comparative, randomized, parallel arm, open label, control group study toevaluate the safety and efficacy of Botroclot in surgical wound closure in C-Section
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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.Age: Reproductive Age Group
- •2.Gender: Pregnant Female Patients undergoing C- section
- •3.Should satisfy Indications of C-Section (Annexure)
- •4.Mentally Sound
- •5.Consents to be a part of the study
- •6.Patients without any local pathology or systemic diseases interfering with
- •7.or influencing haemorrhage, clotting or wound healing.
- •8.Patients with haemogram, bleeding time and clotting time within normal limits and without any bleeding and clotting disorder.
- •9.Patients with a fairly good general health (ASA I & II) without any contraindication for
- •10.C-Section and/or local anesthesia.
- •11.Agrees not to self-medicate or take any other therapies during the study.
排除标准
- •1.Individuals who will not give written consent (wet-ink/electronic)
- •2.Known history of allergy or contraindications for Botroclot, its components
- •3.Patients with known premorbid conditions like, Hypertension, Diabetes Mellitus, GDM
- •4.Patients with mental illness.
- •5.Patients with conditions that affect blood coagulation- Hemophilia, Hypercoagulability,
- •6.Thromboembolic predisposition like deranged lipid profile, any bleeding disorder found
- •7.during screening.
- •8.Individuals on any other medications or nutritional supplements that may influence
- •9.Botroclot i.e. any other coagulant or anti-coagulant.
- •10.Patients undergoing any other form of delivery than C-Section
- •11.Patients with contraindications to spinal anesthesia or drugs used in the procedure.
- •12.Individuals not willing to follow protocol specified guidelines.
- •13.Subjects having any medical or surgical condition that would require immediate medical or
- •14.surgical intervention at the time of screening for this study or during the course of the study.
- •15.History of renal failure or dialysis, Hypercalcemia, Severe Liver Disease (Cirrhosis),
- •16.Sarcoidosis, or other Granulomatous Diseases (Wegener)
- •17.Previously diagnosed cases of immune-compromised status like HIV, Hepatitis B/C,
- •18.Tuberculosis, Cancer, etc. or deranged liver or kidney tests
- •19.Subjects taking or need to take systemic/oral steroid treatment and or any kind of
- •20.immunosuppressive therapy in the pre-study and during the study period
- •21.Subjects participating in any other clinical study or having participated in any other study
- •<1 month prior to screening in the present study
- •22.Other conditions, which in the opinion of the investigators, makes the subject unsuitable for
- •enrolment or could interfere with his participation in, and completion of the protocol.
研究者
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