CTRI/2022/11/047555招募中3 期
A prospective, interventional, open-label clinical study to evaluate the safety and efficacy of KAL-HS-02 in reducing fatigue (Shrama), tiredness (Klama), improving strength (Balya), energy (Urjas) and enhancing quality of life (Swasthakara) among adult volunteers
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 between 18 to 60 years
- •2.Both male and female
- •3. Subject meet criteria for fatigue as per Chalder Fatigue Assessment scale.
- •4.Subjects willing and able to provide informed consent voluntarily
- •5.Patient is willing and able to comply with all trial requirements
排除标准
- •1.Pregnant or Breast feeding.
- •2.Inability to provide voluntary consent.
- •3.Volunteers who have participated in any drug research study within past 3 months
- •4.Patients with pre existing severe systemic disease like uncontrolled diabetes, hypertension, and Cardiac illness etc necessitating long term medication.
- •5.Evidence of significant uncontrolled co morbid disease which in the investigators opinion would jeopardize patient participation.
- •6.Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
- •7.History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ
- •8.Use of any anti psychotic drugs in the past.
- •9.Subjects who abuse drugs or alcohol
- •10.Use of any investigational medication within 4 weeks prior to start of study drug
研究者
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