CTRI/2021/09/036610招募中未知
A Prospective, Open-label, Randomized, Multicenter, Controlled Clinical Trial to Assess the Efficacy and Safety of Mulmina Mango as a Health Supplement in Management of Post-COVID-19 with Standard of Care Treatment among Mild to Moderate COVID-19 recovered subjects
Jagdale HealthCare0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
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.Subjects who have signed the written informed consent form approved by Ethics Committee after understanding the explanations regarding the clinical trial
- •2.Adult male and female subjects, aged between 20 to 50 years (both inclusive)
- •3.Mild to Moderate COVID-19 recovered subjects (patients classified as mild or moderate as per Clinical Management protocol for COVID-19 by MoHFW) and who require treatment for Post-COVID-19 conditions
- •4.Subjects with history of positive RT-PCR test (reverse transcription- polymerase chain reaction) result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus-2) not more than 28 days (4 weeks) at the time of screening.
- •5.Subjects experiencing any signs or symptoms or any non-serious conditions after testing negative to SARS-CoV-2 infection
- •6.Subjects with history of negative RT-PCR report at the time of screening
- •7.Female subjects reported negative pregnancy testing at the time of screening
- •8.Subjects who can read, understand, and fill out/ respond to questionnaires and diary card
- •9.Those who can comply with the requirements and process in the clinical trial.
排除标准
- •1.Subjects with any active autoimmune disorder
- •2.Subjects with the history of major active or chronic unstable psychiatric illness (e.g., bipolar disorder, obsessive compulsive disorder, and schizophrenia)
- •3.Female participants who are pregnant or breastfeeding, lactating, or planning a pregnancy during the clinical trial period
- •4.Subjects with history of hypersensitivity or severe allergic reactions
- •5.Subjects with the history of stage 2 hypertension or subjects with systolic blood pressure (SBP) ââ?°Â¥140 mmHg and/or diastolic blood pressure (DBP) ââ?°Â¥90 mmHg at the time of screening
- •6.Subjects with ALT or AST level exceeds 3 times the normal upper limit of the research institute at the time of screening
- •7.Subjects with self-reported history of chronic diseases such as diabetes, diabetic ketoacidosis, heart disease, liver disease, and kidney disease conditions
- •8.Post-COVID-19 subjects with or progressive towards serious sequelae conditions such as Ischemic heart disease, Thromboembolic complications, Mucormycosis or any other serious conditions
- •9.Subjects with active or untreated malignancy or recovered from malignancy
- •10.Subjects with conditions precluding ingestion or absorption of the investigational product, inflammatory bowel disease, short bowel syndrome, or other major gastrointestinal disease.
- •11.Subjects who are on haemodialysis or peritoneal dialysis
- •12.Subjects with the history of asthma/ Chronic Obstructive Pulmonary Disease (COPD)
- •13.Subjects with severe blood loss within 3 months prior to screening or have known any traits of hemoglobin abnormalities
- •14.Subjects who require intervention of any multivitamin/ nutritional/ antioxidant/immune booster supplements
- •15.Subjects with the history of known infection with Human immunodeficiency virus (HIV), Hepatitis B & Hepatitis C (self-reported)
- •16.Subjects with the history of organ transplant or stem cell transplant
- •17.Drug abuse/alcohol abuse subjects (self-reported)
- •18.Subjects with untreatable or terminal stage illness
- •19.Subjects who participated in another clinical trial within 1 month before screening
- •20.Subjects with any chronic condition or any illness that in the judgement of investigator makes the subject inappropriate for entry into this clinical trial
- •21.Subjects not willing to give voluntary consent and follow protocol procedures.
研究者
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