COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47125

Subham Dutta

raghavendra.kv@jagdale.com

2020-09-02

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

1. Male or non-pregnant female between 20 to 65 years (both inclusive) <br/ >of age at the time of enrolment. <br/ >2. Subject or LAR providing written informed consent and agrees to <br/ >follow study procedure. <br/ >3. Woman with child bearing potential confirming use of primary <br/ >contraception. <br/ >4. Mild to moderate freshly confirmed COVID 19 positive report within 24-48 hours not requiring emergency or ICU care at the time of enrolment and are required to be admitted to the hospital (Dedicated Covid Health Centre) for treatment. <br/ >

1. Severe COVID 19 positive subjects requiring ventilation or oxygen <br/ >support when diagnosed. <br/ >2. Females who are planning to conceive during the study duration or <br/ >are pregnant already or are breastfeeding. <br/ >3. Subjects having serious or unstable respiratory disorders (selfreported). <br/ >4. Subject already on immune therapy (self-reported). <br/ >5. History of Immunodeficiency or organ transplant (self-reported). <br/ >6. Presence of Autoimmune disease (self-reported). <br/ >7. Current acute infection or exacerbation of a chronic illness (selfreported). <br/ >8. Cancer within last 5 years (self-reported). <br/ >9. Known infection with HIV, Hepatitis B & Hepatitis C (self-reported) <br/ >10. Drug abuse/alcohol abuse (self-reported). <br/ >11. Patients with severe cardiac pathologies or any chronic illness or <br/ >comorbid illness (self-reported). <br/ >12. Patients on treatment for Diabetes Mellitus. <br/ >13. Patients with the history of neurological or psychiatric illness (selfreported). <br/ >14. Receiving blood or immunoglobulins within 3 months (selfreported). <br/ >

2

Jagdale Industries Pvt Ltd

20

65

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

50

1. Faster Recovery: clinical symptoms and subjectâ??s critical state defined on 7-point ordinal scale. <br/ >2. Stress: measured by DASS scale <br/ >3. Mental Health: measured through a self-perception Hamilton Anxiety Scale <br/ >4. General Well-being/Systemic Health: measured through a self perception WHO 5 wellbeing scale <br/ >5. Happy Hormones (Dopamine and Serotonin <br/ >6. IgG <br/ >7. T-Lymphocyte Counts: CD4 T cells and CD8 T cells <br/ >8. Anti-viral property: RT-PCR <br/ >9. Antiallergic activity: IgE and CRP <br/ >Timepoint: Enrollment -Discharge - plus 14 days of Follow up

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 834, "treatment_name": "Mulmina mango", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]