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Clinical Trials/CTRI/2024/03/064200
CTRI/2024/03/064200
Not yet recruiting
Phase 2

An Open-label, single-arm clinical trial to evaluate Efficacy and Safety of Hariras Ayurvedic pills for symptomatic relief of acute nonproductive Cough and Throat Irritation - NI

Sushrutkrupa Ayurvedic Pharmacy Pvt. Ltd.0 sites0 target enrollmentTBD

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: J09-J18- Influenza and pneumonia
Sponsor
Sushrutkrupa Ayurvedic Pharmacy Pvt. Ltd.
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Sushrutkrupa Ayurvedic Pharmacy Pvt. Ltd.

Eligibility Criteria

Inclusion Criteria

  • 1\. Male and female subjects (18 to 65 years of age) with history of acute nonproductive cough and throat irritation for less than 1week duration
  • 2\. Subjects with a cough score of 0, 1, or 2 during daytime
  • 3\. Subjects willing and able to provide signed informed consent forms before any study\-related procedures.
  • 4\. Subjects willing to abstain from other medication (allopathic or herbal) for cough treatment during the study period
  • 5\. Subjects who in the opinion of the Investigator will be able to comply with the study requirements

Exclusion Criteria

  • 1\. Subjects with a history of lower respiratory tract infections such as Pneumonia, Tuberculosis, Bronchitis, and Whooping cough.
  • 2\. Subjects with a history of Chronic Obstructive Pulmonary Diseases, Asthma
  • 3\. Subjects with a history of underlying lung pathology such as lung abscess, or cystic fibrosis.
  • 4\. Subjects with known hypersensitivity to any ingredients of the investigational products
  • 5\. Subjects with clinical suspicion of any systemic bacterial infection.
  • 6\. Subjects with a history of Myocardial Infarction (MI) within 4 weeks before enrollment
  • 7\. Subjects with immediate life\-threatening diseases such as pre\-existing cardiovascular, liver or neoplastic disease.
  • 8\. Subjects who had received any sedative, hypnotic or tranquilizer within 14 days before randomization
  • 9\. Subjects who had received any of the anti\-histamines, cough suppressants, mucolytics, expectorants, or antibiotics within 3 days before randomization.

Outcomes

Primary Outcomes

Not specified

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