Use of Herbal Medicine likeTulasi,Amruth(Giloy), Turmeric,Ashwagandha as add on treatment in COVID-19 Patients

Phase 3

Completed

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

• Registration Number: CTRI/2020/06/025592
• Lead Sponsor: Sri Sri Tattva

Brief Summary

Title: A clinical Study to Evaluate the role Herbal Immunomodulators as add on Treatment in Asymptomatic and Mildly Symptomatic COVID-19 Confirmed Cases.

This open Label,  Comparative Interventional  study,conducted among 50 asymptomatic and mildly symptomatic COVID-19 confirmed patients  using Ayurveda Drugs :

**SHAKTI DROPS:** **Dosage:**  5 drops 3 times a day (Morning/ Afternoon/Night)**AMRUTH TABLET:****Dosage:**  1 tablet 2 times a day

**TURMERIC PLUS TABLET:****Dosage:**  1 tablet 2 times a day

**TULSI ARKA:****Dosage:**  10 drops 3 times a day (Morning/Afternoon/ Night).

Inclusion Criteria: Confirmed Asymptomatic and mildly symptomatic cases of COVID-19 infection by laboratory tests

Age limit 18 to 60 years both Male and Female

Uncomplicated cases of COVID - 19 patients on Allopathic medication

Exclusion Criteria:

COVID-19 positive patients above 60 years of age & below 18 years with Symptoms.

Patients with associated comorbidities like hypertension, type 2 or type 1 diabetes mellitus, chronic or acute renal failure

Patients on Immuno-suppression therapy

Pregnant Women or lactating mothers Patients in advanced stage of disease requiring emergency medical intervention like pneumonia, bronchial asthma, organ failure



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|Site: Bangalore Medical college and research institute Primary Outcome: Early recovery in the signs and symptoms of cases of Asymptomatic and mild symptomatic COVID-19 patients by   adding Ayurvedic medicines which are effective in enhancing  immunity of body and reducing the symptoms such as Fever and respiratory distress  on Day 1 and Day 30 Seconadry Outcome:TNF-α, IL-6, IFN- β, IFN-λ  on Day 1 and Day 30

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-13
• Study Completion: 2020-11-07
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Confirmed Asymptomatic and mildly symptomatic cases of COVID-19 infection by laboratory tests Age limit 18 to 60 years both Male and Female Uncomplicated cases of COVID.
• 19 patients on Allopathic medication Patients in whom ventilator support is not required Patients with no associated co morbidities Patients willing to give informed consent to participate in the clinical trial.

Exclusion Criteria

• COVID-19 positive patients above 60 years of age & below 18 years with Symptoms.
• Patients with associated comorbidities like hypertension, type 2 or type 1 diabetes mellitus, chronic or acute renal failure Patients on Immuno-suppression therapy Pregnant Women or lactating mothers Patients in advanced stage of disease requiring emergency medical intervention like pneumonia, bronchial asthma, organ failure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early recovery in the signs and symptoms of cases of Asymptomatic and mild symptomatic COVID-19 patients by adding Ayurvedic medicines which are effective in enhancing immunity of body and reducing the symptoms such as Fever and respiratory distress	Day 1 and Day 30

Secondary Outcome Measures

Name	Time	Method
a. TNF-α	b. IL-6

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