Clinical trial on Ayurvedic product for viral and bacterial infections

Phase 3

Completed

• Conditions: Acute bronchitis due to respiratory syncytial virus,

• Registration Number: CTRI/2020/07/026434
• Lead Sponsor: VENKAT PHARMA

Brief Summary

Earlier clinical studies using Nutraceutical ingredients of herbal origin have demonstratedsignificant improvement in Immunity.

HERBOVIR is an herbal preparation containing multipleherbal extracts known to boost immunity.

These herbals are used for various infectious ailmentsfrom many centuries and with abundant literature evidences

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-13
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Subjects aged 18-65 years of age and of either sex 2.subjects who were disposed to give consent to the study and willing for follow-up 3.Subjects who are willing to sign ICF 4.Clinical signs and symptoms of an URTI with a duration of up to 24 hours accompanied with or without fever 37.5 C (axillary body temperature) or higher 5.At least 1 of 3 types of URTI symptoms – Nasal (plugged nose, runny nose, sneezing), Pharyngeal (scratchy throat, sore throat, pharyngeal hyperaemia), Cough (ordinary cough without suspicion of acute lower respiratory tract disease).
• At least 1 of 5 general symptoms – feeling tired, weakness, body ache, irritable or whiney,or less active 6.Not be in need of hospitalized medical care at screening.

Exclusion Criteria

• 1.Age less than 18 years and more than 65 years 2.Pregnancy 3.Severe or complicated course of URTI.
• 4.Signs of acute lower respiratory tract disease.
• 5.Daily use of antibiotics, steroids and cytotoxic agents.
• 6.Any uncontrolled systemic disease, infection 7.Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or Renal disease• or any other disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Wisconsin Upper Respiratory Symptom Survey	Day 0 to Day 7

Secondary Outcome Measures

Name	Time	Method
•Adverse events (AEs),	•frequency and severity Number of subjects who discontinue study due to adverse events

Trial Locations

Locations (1)

Sri Venkateshwara Hospitals; 🇮🇳 Rural, KARNATAKA, India

Sri Venkateshwara Hospitals

🇮🇳Rural, KARNATAKA, India

DrShubarani

Principal investigator

9449453674

dr.shubharani111@gmail.com