Arsenicum album 30 C for COVID-19 prevention.

Immunological responses of Arsenicum album 30C to combat COVID-19: A double-blind, randomized, placebo controlled clinical trial in the Pathanamthitta district of Kerala

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/08/045089

Enrollment

224

Registered

2022-08-30

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

None listed

Interventions

Intervention1: Homoeopathic medicine: Arsenicum album 30 C in one grain tablet form to be administered orally for three consecutive days at the beginning of each 21-day schedule for three schedules.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Residents of Pathanamthitta district of Kerala. 2. Participants with negative COVID-19 RT-PCR test report at least 48 hours before first day of intervention. 3. Participants who have not taken homoeopathic medicine Arsenicum album as preventive or as medication for any ailment in last one month. 4. Both COVID-19 vaccinated and unvaccinated participants.

Exclusion criteria

Exclusion criteria: 1. Participants with positive COVID-19 RT-PCR test report at least 48 hours before first day of intervention. 2. Participants having history of severe viral diseases like herpes zoster, dengue, chikungunya, chicken pox etc. in the past 3 months. 3. Participants having previous history of chronic respiratory ailments with shortness of breath as recurring symptom. 4. Participants taking concomitant medications like immuno-suppressants, hormonal therapies etc. or Ayush therapies for chronic ailments.

Design outcomes

Primary

Measure	Time frame
1. Antigen density and modulation in immunological markers (CD3, CD4, CD8, CD24, CD27, CD-38, CD4 IFN-?, CD4 CD17, CD4 CD25 (activated T lymphocytes), T-cells, B-cells, mature and immature DCs and NK cells) observed from the serum sample drawn, one day before and three days after the intervention (i.e. on day 1, 5, 23, 27, 45 & 49) and at the end of the study (day 66). 2. Investigate the innate and acquired immune responses from the blood sample drawn on day 1 day 23 day 45 and day 66 of the study intervention. 2. Investigate the innate and acquired immune responses from the blood sample drawn on day 1, day 23, day 45 and day 66 of the study intervention.Timepoint: 1. Day 1, 5, 23, 27, 45, 49, 66) 2. Day 1, 23, 45, 66	—

Measure

Time frame

1. Antigen density and modulation in immunological markers (CD3, CD4, CD8, CD24, CD27, CD-38, CD4 IFN-?, CD4 CD17, CD4 CD25 (activated T lymphocytes), T-cells, B-cells, mature and immature DCs and NK cells) observed from the serum sample drawn, one day before and three days after the intervention (i.e. on day 1, 5, 23, 27, 45 & 49) and at the end of the study (day 66). 2. Investigate the innate and acquired immune responses from the blood sample drawn on day 1 day 23 day 45 and day 66 of the study intervention. 2. Investigate the innate and acquired immune responses from the blood sample drawn on day 1, day 23, day 45 and day 66 of the study intervention.Timepoint: 1. Day 1, 5, 23, 27, 45, 49, 66) 2. Day 1, 23, 45, 66

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Secondary

Measure	Time frame
Number of participants developing COVID-19 like symptoms as per NCDC guidelines during follow ups in any of the three schedules of intervention.Timepoint: During follow ups in any of the three schedules of intervention.;Number of participants with COVID-19 like symptoms testing positive for COVID-19 RT- PCR during follow ups in any of the three schedules of intervention.Timepoint: During follow ups in any of the three schedules of intervention.;The toxicity status of study participants who were taken placebo or Arsenicum album 30C will be compared based on the hepatotoxicity, renal output, hematological parameters, and peripheral smears one day before and three days after the intervention and at the end of the study.Timepoint: One day before and three days after the intervention (i.e., Day 1, 5, 23, 27, 45 & 49) and at the end of the study (Day 66).	—

Measure

Time frame

Number of participants developing COVID-19 like symptoms as per NCDC guidelines during follow ups in any of the three schedules of intervention.Timepoint: During follow ups in any of the three schedules of intervention.;Number of participants with COVID-19 like symptoms testing positive for COVID-19 RT- PCR during follow ups in any of the three schedules of intervention.Timepoint: During follow ups in any of the three schedules of intervention.;The toxicity status of study participants who were taken placebo or Arsenicum album 30C will be compared based on the hepatotoxicity, renal output, hematological parameters, and peripheral smears one day before and three days after the intervention and at the end of the study.Timepoint: One day before and three days after the intervention (i.e., Day 1, 5, 23, 27, 45 & 49) and at the end of the study (Day 66).

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Countries

India

Contacts

Public ContactDr D Biju Kumar

Central Council for Research in Homoeopathy

sui.azis@gmail.com9810554024

Outcome results