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A clinical trial to evaluate the effectiveness and safety of Vedicinals-9-a Herbal Formulation in Mild to Moderate COVID-19 Patients.
CTRI; 12-10-2020; TrialID: CTRI/2020/10/028364
Clinical Trial Register | ICTRP | ID: ictrp-CTRI202010028364
ABSTRACT

Condition

Health Condition 1 B972- Coronavirus as the cause of diseases classified elsewhere

Intervention

Intervention1 Vedicinals-9 along with standard care Vedicinals-9-Active (9 compounds) 5000 mg in Additive 50 ml suspension per day [100 mg/ml suspension] Loading dose on day 1 - 25 ml each at 1 hour before breakfast, lunch and dinner. Maintenance dose from day 2 to day 12 ± 2 days - 20 ml, 15 ml and 15 ml at 1 hour before breakfast, lunch and dinner, respectively.

Standard Care-as per the Ministry of Health and family welfare guidelines for COVID-19.
Control Intervention1 Standard Care Standard Care as per the Ministry of Health and family welfare guidelines for COVID-19.


Primary 

outcome:

a) Percentage of COVID-19 patients and time taken to get COVID-19 RT-PCR negative

b) Time of convalescence and improvement in altered biomarkers post COVID-19 infectionTimepoint a) Days from admission, days from first testing positive, days from first noticed symptoms



b) At screening, day 5, day 12 and day 45

Criteria

Inclusion criteria 1. Individuals of either sex above 18 and below 60 years of age

2. Individuals who have been tested positive to be infected with SARS-COV2 Virus and presenting with no symptoms or mild to moderate symptoms.

3. Voluntariness to participate in the trial and give signed informed consent.



Exclusion criteria 1. COVID-19 Patients with symptoms classified as severe or critical

2. Individuals with uncontrolled, unstable comorbidities as evaluated by the investigators.

3. Individuals with preexisting respiratory conditions, severe primary respiratory disease or pneumonia.

4. Immuno-compromised Individuals or those on immunosuppressant

5. Patients on or requiring parenteral nutrition/care.

6. Pregnant/lactating women.

7. COVID-19 positive individuals participating in the interventional arm of other COVID-19 clinical trial.

8. Individuals with serious complications of diseases such as cancer, heart disease, infraction, stroke, arterial fibrillation, cardiac arrhythmia, disabilities, neurodegenerative disease.

9. Subjects with alcohol and/or substance dependence.

10. Subjects with known allergic reactions to any other herbal supplements.

Collection: Clinical trial registers Database: ICTRP Document Type: Clinical Trial Register Type of study: Controlled clinical trial Year: 2020

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Collection: Clinical trial registers Database: ICTRP Document Type: Clinical Trial Register Type of study: Controlled clinical trial Year: 2020
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