Effects of health drink additional to standard of care treatment in COVID 19 patients

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: Intervention1: Mulmina mango drink plus standard of care treatment.: Mulmina mango is rich in antioxidants, vitamins, minerals and mesonutrients. Mulmina mango contains extracts from mango, centella asiatica and turmeric. Dosage: 2 Tetrapak Packs of 200 ml each per Day. Control Intervention1: standard of care treatment: The standard of care treatment will be as prescribed by the treating doctor as per the revised clinical management protocol for COVID‐19 as issued by Govt of India, MoHFW. Dosage: As prescribed by the treating physician. CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: 1. Faster Recovery: clinical symptoms and subjectâ??s critical state defined on 7‐point ordinal scale. ; 2. Stress: measured by DASS scale ; 3. Mental Health: measured through a self‐perception Hamilton Anxiety Scale ; 4. General Well‐being/Systemic Health: measured through a self perception WHO 5 wellbeing scale ; 5. Happy Hormones (Dopamine and Serotonin ; 6. IgG ; 7. T‐Lymphocyte Counts: CD4 T cells and CD8 T cells ; 8. Anti‐viral property: RT‐PCR ; 9. Antiallergic activity: IgE and CRP ; Timepoint: Enrollment ‐Discharge ‐ plus 14 days of Follow up SECONDARY OUTCOME: 1. SGOT and SGPT level measured at baseline and discharge. ; 2. Occurrence of any AE or SAE. ; 3. HRQOL.Timepoint: Enrollment ‐Discharge ‐ plus 14 days of Follow up INCLUSION CRITERIA: 1. Male or non‐pregnant female between 20 to 65 years (both inclusive) of age at the time of enrolment. 2. Subject or LAR providing written informed consent and agrees to follow study procedure. 3. Woman with child bearing potential confirming use of primary contraception. 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.
Epistemonikos ID: 3fc660683dc6c310c3eaa4c9910951ae8634be0f
First added on: Sep 10, 2020