Clinical study on Zandu Chyavanprash as a preventive remedy in pandemic of Covid-19.

Clinical evaluation of Zandu Chyavanprash as an immunity booster for its preventive effect on infections in pandemic of COVID-19 â?? An open label, Multi centric, Randomized, Comparative, Prospective, Interventional Community based Clinical Study on Healthy individuals - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/01/030454

Enrollment

300

Registered

2021-01-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Zandu Chyavanprash and Milk: Zandu Chyavanprash contains Bilva, Agnimantha, Syonaka, Patala, Gambhari, Shalaprani, Prishniparni , Brihati, Kantakari, Gokshura, Bala, Mudgaparni, Mashapa

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy individuals will be considered as those who do not have any acute medical condition or chronic medical or surgical condition that requires either immediate or continuous medical monitoring or treatment. 2. Subjects tested Negative for total antibodies for COVID-19 3. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.

Exclusion criteria

Exclusion criteria: 1.Pregnant and Lactating females 2. Subjects who have been confirmed of having COVID-19 and have been isolated for its treatment. Subjects having recently suffered and recovered of COVID-19 will also be excluded from the study 3. Known cases of Diabetes 4. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening 4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc. 5. Subjects taking steroid treatment and or any kind of immunosuppressive therapy 6. Subjects participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study. 7. Subjects having a past history of allergy to Chyawanprash like products 8. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol

Design outcomes

Primary

Measure	Time frame
1. Change in incidence of COVID-19 [by RT- PCR and or total antibody fo r[COVID-19] in subjects taking Zandu Chyavanprash and those not taking it 2. Change in incidence of other non COVID-19 infections in subjects taking Zandu Chyavanprash and those not taking itTimepoint: Screening visit (day -5), baseline visit (day 0), day 15, day 30, day 45, day 60, day 75 and day 90.	—

Secondary

Measure	Time frame
1. Change in severity of COVID-19 (when it occurs) between two groups 2. Change in number of subjects requiring hospitalization etc between two groups. 3. Change in ordinal scale for clinical improvement of COVID-19 between two groups 4. Change in incidence and severity of other allergy related health between two groups 5. Changes in Quality of life between two groups 6. Change in global assessment for overall change as per the investigator 7. AE and SAE assessmentTimepoint: Screening visit (day -5), baseline visit (day 0), day 15, day 30, day 45, day 60, day 75 and day 90.	—

Measure

Time frame

1. Change in severity of COVID-19 (when it occurs) between two groups 2. Change in number of subjects requiring hospitalization etc between two groups. 3. Change in ordinal scale for clinical improvement of COVID-19 between two groups 4. Change in incidence and severity of other allergy related health between two groups 5. Changes in Quality of life between two groups 6. Change in global assessment for overall change as per the investigator 7. AE and SAE assessmentTimepoint: Screening visit (day -5), baseline visit (day 0), day 15, day 30, day 45, day 60, day 75 and day 90.

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Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research

targetinstitute@yahoo.com9322522252

Outcome results