Role of Herbal Immunomodulators in mild COVID-19 confirmed cases

Phase 2/3

Completed

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/06/025801
• Lead Sponsor: The Himalaya Drug Company

Brief Summary

**A Clinical Study to Evaluate the role of Herbal Immunomodulators (Tab Septilin and Tab Bresol) as add on treatment in Asymptomatic and mildly symptomatic COVID-19 confirmed cases**

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-19
• Study Completion: 2020-08-25
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Subjects who are COVID-19 confirmed cases, with mild severity presenting with signs and symptoms qualifying for Low Clinical Risk (News Scoring 0-4) 2.
• Subjects with SARS-CoV-2 RT-PCR confirmed COVID-19 positive within 7 days from symptom onset or Patients within 48 hours after laboratory diagnosis (SARS-CoV-2 RT-PCR).
• 3.Female of childbearing potential willing to follow reliable and strict contraceptive measures.
• 4.Subject judged to be reliable for compliance for taking medication and capable of recording the effects of the medication and motivated in receiving benefits from the treatment and compliance to quarantine procedure (as per prevailing guidelines).
• Able to give written inform consent to participate in the study.

Exclusion Criteria

• 1.Confirmed COVID-19 positive cases with NEWS scoring system ≥5.
• 2.Individual with acute respiratory distress presenting with RR> 24/mt, SaO2/SPO2≤94% in room air condition, or the Pa02/Fi02 ratio <300mgHg. 3.Pregnant or breastfeeding females.
• 4.Recent history of significant lung disease like Asthma or Chronic Obstructive Lung Disease (COPD).
• 5.Unable to take oral medication or suffering from ailments related to absorption.
• 6.Suffering from Immunocompromising conditions or taking any immunosuppressing therapy.
• 8.The subject with known hypersensitivity to any of the test materials or related compounds.
• 10.Physician makes a decision that trial involvement is not in patients best interest, or any condition that does not allow the protocol to be followed safely.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number & Percentage (%) of subjects converting into positive test for COVID-19	Visit-1 Baseline | Visit-2 Date of discharge | Visit-3(Telephonic) 7 days from the date of discharge±1day | Visit-4 14 days from the date of discharge ±3day | (EOS)
Protection as defined by various laboratory parameters related to inflammation and immunity	Visit-1 Baseline | Visit-2 Date of discharge | Visit-3(Telephonic) 7 days from the date of discharge±1day | Visit-4 14 days from the date of discharge ±3day | (EOS)
Time to convert 2019 nCoV RT PCR in negative in upper respiratory tract specimen	Visit-1 Baseline | Visit-2 Date of discharge | Visit-3(Telephonic) 7 days from the date of discharge±1day | Visit-4 14 days from the date of discharge ±3day | (EOS)
Time to Clinical Recovery	Visit-1 Baseline | Visit-2 Date of discharge | Visit-3(Telephonic) 7 days from the date of discharge±1day | Visit-4 14 days from the date of discharge ±3day | (EOS)
No. & Percentage (%) of subjects converting into severe cases.	Visit-1 Baseline | Visit-2 Date of discharge | Visit-3(Telephonic) 7 days from the date of discharge±1day | Visit-4 14 days from the date of discharge ±3day | (EOS)
Lenth of Hospital stay	Visit-1 Baseline | Visit-2 Date of discharge | Visit-3(Telephonic) 7 days from the date of discharge±1day | Visit-4 14 days from the date of discharge ±3day | (EOS)
Proportion of clinical failure -ICU admission, mechanical ventilation or death	Visit-1 Baseline | Visit-2 Date of discharge | Visit-3(Telephonic) 7 days from the date of discharge±1day | Visit-4 14 days from the date of discharge ±3day | (EOS)
Overall well-being	Visit-1 Baseline | Visit-2 Date of discharge | Visit-3(Telephonic) 7 days from the date of discharge±1day | Visit-4 14 days from the date of discharge ±3day | (EOS)

Secondary Outcome Measures

Name	Time	Method
No. & Percentage (%) of subjects having recurrence of COVID-19 within two weeks after discharge	cases.

Trial Locations

Locations (1)

Bangalore Medical college and research institute; 🇮🇳 Bangalore, KARNATAKA, India

Bangalore Medical college and research institute

🇮🇳Bangalore, KARNATAKA, India

Dr C R Jayanthi

Principal investigator

9448292424

bmccrj@gmail.com