A Single-Center, Prospective, Open Labeled, Phase IV Clinical Study to Evaluate Safety and Efficacy of MY V3 Immune Capsules in Healthy Participants.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1.Improvement in the Immune Status Questionnaire (ISQ) from baseline to end of the study
研究概览
简要总结
Sidhvaa MyV3 Immune herbal capsules are food supplements derived from the combination of carefully selected herbs, which is a source of immunity in the daily consumption.
This food supplement has a therapeutic effect of the ingredients like ThuthiVidhai, Thannervittan, Vembu, Beetroot, Vallarai, Musli, Aragampul, Amla, Liqorice, Murungai, Thetraakottai, Triphala, Aswagandha. The ingredients have the effect of improving immunity, General health, can be effective for people who are Anemic, Insomnia and also helps in stress management
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 69.00 Year(s)（—）
- 性别
- All
入选标准
- •Male/females of greater than or equal to 18 years of age at the time of consent 2) Patient / Legally Acceptable Representative who can and willing to provide Informed Consent 3) Confirmed anemia 4) Clinically stable for at least 1 month prior to entry into the study 5) Score on the Insomnia Severity Index (ISI) measure greater than or equal to 15.
排除标准
- •Pregnant or lactating women or women of childbearing potential who did not use oral contraceptives or an intrauterine device 2) Administration of another investigational drug within 1 month before screening or planned during the study period 3) Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol 4) Diagnosis of other primary sleep disorders 5) Psychotherapy within the past six months 6) Shift workers 7) Current or expected use of hypnotic medications 8) Renal or hepatic disease 9) History of Neurological disorder or cardiovascular disease raising safety concerns 10) Excessive coffee or cigarette use 11) Recent surgery 12) Current alcohol/substance use disorder 13) Current major depressive episode.
结局指标
主要结局
1.Improvement in the Immune Status Questionnaire (ISQ) from baseline to end of the study
时间窗: 2 months
2.Improvement in Hemoglobin level from baseline to end of the study
时间窗: 2 months
次要结局
- 1.Improvement in the Liver function test (LFT) Parameters.(2.Improvement in the (Pittsburgh Sleep Quality Index PSQI) from base line to end of the study.)
研究者
Dr MS Ramasamy
Sanjeev Biomedical Research Center