A Clinical Study Know the efficacy of Ayurveda Medicines in COVID 19 Positive Patients

Phase 4

Not yet recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere. Ayurveda Condition: JVARAH, (2) ICD-10 Condition: B338||Other specified viral diseases. Ayurveda Condition: JVARAH,

• Registration Number: CTRI/2021/08/035815
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

This study is a randomized parallel group open label clinical study comparing the efficacy of add-on Ayurveda intervention (Sudarshana churna, Yestimadhu churna and Amritharista) and Conventional treatment daily for 2 weeks in 52 subjects (26 in each group) in COVID 19 positive patients that will be conducted at Victoria Hospital, Bangalore Medical College and Research Institute, Bengaluru. The primary outcome measures will be changes in COVID 19 symptomatology, RT-PCR and IL-6 at 2 weeks. The secondary outcome measures will be changes in hospital length stay, intensive care unit free days, oxygen saturation and Hospital Anxiety and depression Scale (HADS) at 2 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-09
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• 1. Patients positive for COVID 19 confirmed by RT-PCR.
• 2. Patients with mild to moderate symptoms (NEWS 2 criteria).

Exclusion Criteria

• Patients with 1) Diabetes Miletus.
• 2. Hepatic dysfunction 3) Renal dysfunction 4) Pulmonary dysfunction 5) Cardiovascular disease 6) Debilitating Neurological disorders.
• 7. Psychiatric illness.
• 8. Pregnant and Lactating.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in	2 weeks
1) COVID 19 Symptomatology.	2 weeks
2) RT-PCR	2 weeks
3) IL-6	2 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in	1) Hospital length stay.

Trial Locations

Locations (1)

Victoria Hospital, Bangalore Medical College & Research Institute; 🇮🇳 Bangalore, KARNATAKA, India

Victoria Hospital, Bangalore Medical College & Research Institute

🇮🇳Bangalore, KARNATAKA, India

Dr Shashi Bhushan BL

Principal investigator

9448239644

shashibhushanbmcri@gmail.com