Prospective, Open label, Parallel Arm, Single center Exploratory study to assess effect of Swamala consumption on improving immune functions and Quality of life in healthy human volunteers
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change in levels of immune markers and Improvement in Quality of life
研究概览
简要总结
The present clinical study is planned to show immunogenicity of Swamala, in clinical trial settings.
The primary objective of the study is to evaluate immunogenicity in terms of improvement in immune markers and improvement in Quality of life after consuming Swamala daily for the study duration of 90 days.
Healthy volunteers (fully vaccinated for COVID-19) will be screened and if found eligible, they will be enrolled in the study and randomized into 2 groups in ratio of 2:1 (20 participants in in Swamala Group and 10 in Control Group = Total 30 participants).
One group (S) will be put on Swamala 10 gm twice daily, and the other group (C) will not be consuming the investigational product.
Participants will be followed-up 6-weekly during the treatment period of 90 days, and telephonic reminders and enquiries will be done every 7 days to ensure compliance, enquire about any episodes of general illness or COVID-19 & absent days from work due to illness/es, and collect safety data, in terms of any adverse effects experienced by the participants.
Compliance of at least 80% will be required for the participant to complete the study.
Appropriate statistical tests will be applied to data generated through clinical trial to reach to conclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •Healthy adult volunteers aged 18- 60 years Voluntarily participating in the study; fully understanding and being fully informed of the study and has signed written Informed Consent Form (ICF).
- •Free of obvious health problems as established by medical history of past 3 months& clinical examination before entering into the study.
- •No evidence of any acute severe infection or moderate to high grade Fever (Axillary Temp.>99OF) Not being COVID-19 positive within past 15 days at the time of screening.
- •Having taken 2 doses of Covishield / 2 doses of Covaxin Covid-19 vaccine.
排除标准
- •1.Refusal to participation expressed by patient.
- •2.Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- •3.Past 3 months history of or any complaints suggestive of significant gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological (including generalized or partial epilepsy), endocrine, rheumatological, urogenital or hematological disease.
- •4.Presence of any Covid related symptoms like fever, cough, breathlessness, diarrhea etc.
- •5.Severe hepatic or renal impairment.
- •(Presence of values which are out of acceptable limits for LFT and/or RFT) 6.Diagnosed of Diabetes Mellitus type –II.
- •7.Uncontrolled Hypertension (>160/110 mmHg) 8.Presence of acute gastrointestinal symptoms at the time of screening (e.g., nausea, vomiting, diarrhea, heart burn) 9.Presence of values which are out of acceptable limits for hematological parameters(CBC).
- •10.Administration of immunoglobulin (including Tocilizumab for Covid-19 infection treatment )or any blood products in last 3 months 11.Vaccination within past 6 months, other than Covid-19 vaccine.
- •12.Pregnant or lactating women.
- •13.Women of child bearing age group not following contraceptive measures.
- •14.Participants who have participated in any clinical trial within 30 days prior to enrolment and/or intending to participate in any other clinical study during the period of this study.
- •15.Any other Chyawanprash or ayurvedic drug as immunoadjuvant, consumption concomitantly.
- •16.History of hypersensitivity to any drug, allergic disease or reactions likely to be exacerbated by any component of the Chyawanprash.
- •17.Confirmed immunosuppression or immunological disorders.
- •18.History of corticosteroid or other immunosuppressive drugs taken in the past 3 months.
- •19.Presence of HIV 1 or 2, Hepatitis B or C infection or venereal infection, as per history and medical records.
- •20.Currently undergoing anti-TB treatment.
- •22.Clinically abnormal ECG (12 lead), QTc >440 msec 23.Presence of significant infection or known inflammatory process, indicated by raised CRP.
- •24.History of drug dependence or habitual alcohol abuse.
结局指标
主要结局
change in levels of immune markers and Improvement in Quality of life
时间窗: Day 1 Day 45 Day 90
次要结局
- 1. Difference in number of episodes of general illness (fever, cough, cold) and their severity, duration of illness, between both arms.(2. Difference in rate of COVID-19 infection acquired during study duration and levels of Covid antibodies between participants in both arms.)