A study on the efficacy of Tulasi-Ashwagandhadi Herbal Drops on Oxygen Saturation (SPO2) in the management of COVID-19 affected cases.

Phase 2

Suspended

Brief Summary: Covid-19 is a pandemic health challenge that has affected millions of people around the world today. The present health setup is trying its level best to control and improve the condition in this regard. Its symptoms range from Mild to Severe which is at times even life threatening. The product is an Ayurvedic formulation where the combination of the herbs that are basically used in many Ayurvedic formulaitons that have been found to be useful in the management of symptoms namely Kasa (Cough), Shwasa (Dyspnea), Jwara (Hyperpyrexia)*,* Shotha (Inflammation)etc. These symptoms are found in the mild cases of Covid-19 pandemic too especially in the mild cases.

Hence, the current study is planned to evaluate the safety and efficacy of the product in mild to moderate cases of Covid-19 affected to male and female subjects as an adjuvant to the general existing treatment protocol.

Recruitment & Eligibility

Inclusion Criteria

Male or female subjects who have been found to be COVID-19 positive The Oxygen Concentration level (SpO2) is between 85-95% observable during baseline screening.
Subjects in the age group 18-65 years (both the ages inclusive).
Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
Subjects with mild to moderate level of symptoms pertaining to COVID-19 Subjects willing to abide by and comply with the study protocol.
Subjects who have not participated in a similar investigation in the past three months.

Exclusion Criteria

Subjects who have undergone invasive treatments like surgery or other treatment within 3 months before screening into the study.
Subjects having any active disease which may interfere in the study.
Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
Subjects (females) who are pregnant or lactating A known history or present condition of allergic response/hypersensitivity to any ingredients and pharmaceutical products.
Chronic illness which may influence the respiratory state.
Subjects who had been part of any other clinical study within 3 months before screening into the study.

Primary Outcome Measures

Name	Time	Method
To study the efficacy of Test product in elevation of SpO2 Concentration over Treatment Phase and Followup Phase in comparison to Baseline	Baseline, Day1, Day4, Day7, Day14 and Day21

Secondary Outcome Measures

Name	Time	Method
To study the efficacy of Test product in SpO2 Conc elevation after Day1 Day4 and Day7 of treatment in comparison to baseline	Day1 vs baseline

Locations (1): Alvas Ayurveda Medical College and Hospital
🇮🇳
Kannada, KARNATAKA, India
Alvas Ayurveda Medical College and Hospital
🇮🇳Kannada, KARNATAKA, India
Dr Mahesh T S
Principal investigator
9448160784
dtsmv2002@gmail.com