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
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.% Improvement in Chalder Fatigue Scale (CFQ 11) (Time points: Baseline, Day 7, Day 14, Day 28)
研究概览
简要总结
Fatigue is a most commoncondition observed in general population. However, the definitive management offatigue, tiredness, low energy syndrome is vaguely defined, Ayurveda, theIndian traditional system of medicine, is one of the world’s oldest medicine systemswhich has defined management with well-known herbs used from ancient times withproven safety and efficacy. Hence the present study is designed to evaluate thesafety and efficacy of this unique herbal combination in fatigue, tiredness andlow energy as a holistic approach. This unique herbal formulation has multipleactive ingredients with multiple mechanism of actions. These ingredients are usedin India and Asian countries from many centuries and having vast literature ontheir safety and efficacy. The active ingredients in this formulation are Woodfordiafruiticosa, Vitis vinifera, Madhuca indica, Cyperus rotundus, Hemidesmusindicus, Nelumbo nucifera, Emblica offcinalis, Sphaeranthus Indicus, Tinosporacordifolia, Terminalia chebula, Acacia catechu, Piper nigrum, Curcuma longa,Messua ferrea, Rubia cordifolia, Inula racemose, Apium graveolens, Terminaliabelerica, Piper longum, Embelia ribes, Elettaria cardamomum, Syzygiumaromaticum, Cinnamomum zeylanicum, Jaggery and Honey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age between 18 to 60 years 2.Both male and female
- •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.
结局指标
主要结局
1.% Improvement in Chalder Fatigue Scale (CFQ 11) (Time points: Baseline, Day 7, Day 14, Day 28)
时间窗: Day 0day 7 ,Da 14 and Day 28
2.% Improvement in energy/fatigue scale of the RAND-36 questionnaire. (Time points: Baseline, Day 7, Day 14, Day 28)
时间窗: Day 0day 7 ,Da 14 and Day 28
次要结局
- 1.Assessment of Total energy expenditure and Physical Activity (IPAQ Questionnaire)(Baseline (Day 0) and Day 28)