Clinical trial for TADIOS as supplemental therapy in mild to moderate COVID-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/03/031940
- Lead Sponsor
- Helixmith Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or Female, aged between 18 to 65 years (both inclusive)
2.Confirmed Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) first infection by a reverse transcription polymerase chain reaction (RT-PCR) assay in nasal swab or oropharyngeal swab samples.
3.Patients who are hospitalized into designated hospital for COVID 19 treatment
4.Patients who can be treated within 24 hours after confirmed diagnosis with COVID-19
5.Patients with mild COVID-19 or moderate COVID-19 according to clinical management guideline of Government of India.
a) Mild Illness: Patients with uncomplicated upper respiratory tract viral infection, may have non-specific symptoms such as fever, cough, sore throat, nasal congestion, malaise, and headache. The elderly may present with atypical symptoms. These patients do not have any signs of dehydration, sepsis or shortness of breath.
b) Moderate Illness: Patient with pneumonia and no signs of severe pneumonia (Chest X-ray will be performed to rule out pneumonia in the suspected subjects).
6.Patients who have signed the written informed consent form approved by Ethics Committee to participate after understanding explanations regarding the study
7.Those who can comply with the requirements and processes in the clinical study
8.Women of childbearing age must be negative to urine pregnancy test during screening
1.Patients with severe COVID-19
2.Self-reported history of meaningful circulatory, renal, gastrointestinal, liver, endocrinal, hematological, or mental disease, or other serious diseases or alcohol or drug addiction that may cause safety issues or confusion in the interpretation of clinical research results by the principal investigatorââ?¬•s judgment
3.Female patients who are pregnant (confirmed through urine pregnancy test) or breastfeeding
4.Patients with cardiovascular, liver, and kidney disease
5.Self-reported patients being a recipient of immunosuppressive therapy
6.Self-reported patients who are allergic to this dietary supplements
7.Patients taking a health functional food or medicine that may affect the bodyââ?¬•s antioxidant, anti-inflammatory activity, and lungs within 6 weeks of the first visit
8.Patients who participated in another clinical trial within 1 month before screening
9.Patients have any condition that in the judgement of investigator make the subject inappropriate for entry into this study
10.Patients consuming any herbal medicine
11.Self-reported patients with cases of surgical menopause (hysterectomy, oophorectomy of both ovaries) or sterilization procedures (tubal ligation or tubectomy of both fallopian tubes). Menopause refers to 1 year of no menstruation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Antioxidative and inflammatory biomarkers: TNF-�±, CRP, IL-6, IL-1ra, Hb, and Ferritin <br/ ><br>(2)Clinical measurements- <br/ ><br>a) 8-point ordinal scale for clinical improvement <br/ ><br>b) Time to clinical recovery in clinical symptom scale <br/ ><br>c) Proportion of clinical improvement in clinical in symptom scale <br/ ><br>(3)Quality of life <br/ ><br>a) WHOQOL-WHO 5 wellbeing scale <br/ ><br>b) Fatigueness assessment through fatigue severity scale <br/ ><br>(4)Hospitalization <br/ ><br>a) Duration of hospitalization <br/ ><br>b) Time to discharge <br/ ><br>Timepoint: Day 0, Day 10 or discharge or early termination, and Day 14. <br/ ><br>clinical symptom scale daily till discharge
- Secondary Outcome Measures
Name Time Method (1)Adverse event <br/ ><br>(2)Hematological test, general chemical test, and urine test <br/ ><br>(3) Vital signs <br/ ><br>Timepoint: (1)Adverse events: Day 2, 4, 7 and 10/discharge/early termination <br/ ><br>(2)Hematological test, general chemical test, and urine test: screening, Day 10/discharge/early termination and Day 14 <br/ ><br>(3)Vital signs: screening, Day 0, 2, 4, 7, 10/discharge/early termination and Day 14 <br/ ><br>