Clinical evaluation of the effect on oral administration of Siddha classical drug VILVA ENNAI for the treatment of BRONCHIOLITIS.
Phase 2
Completed
- Conditions
- Acute bronchiolitis, unspecified,
- Registration Number
- CTRI/2021/01/030216
- Lead Sponsor
- Dr K Ragavi Sayi Saranya
- Brief Summary
The study is a single arm clinical trial to evaluate the therapeutic efficacy of VILVA ENNAI for the treatment of VALI KANAM. The trial drug will be administered orally at the dose of 4 ml before the food once a day at morning for a period of 10 days in 56 patients. The trial period of 24 months will be carrying out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- subjects with any of the following symptoms will be included in the study 1.
- Fever associated with Respiratory symptoms, Urinary tract symptoms and Gastrointestinal symptoms 2.
- Loss of appetite 3.
- Vomitting 5.
- Wheezing 6.
- Decreased urine output 7.
- Dryness of mouth 9.
- Constipation.
Exclusion Criteria
- Children below 3 years and above 12 years 2.
- Fever due to malignancy, trauma, psychological factors 3.
- High grade fever 4.
- Cough with hemoptysis 5.
- Fever associated with other complications such as HIV, meningitis, Tuberculosis 6.
- Cardiac diseases 7.
- Chronic Renal diseases 8.
- Severe Dehydration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decreases the body temperature, cough, vomitting, constipation and other clinical symptoms. 10 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Government siddha medical college and hospital, Palayamkottai
🇮🇳Tirunelveli, TAMIL NADU, India
Government siddha medical college and hospital, Palayamkottai🇮🇳Tirunelveli, TAMIL NADU, IndiaDr K Ragavi Sayi SaranyaPrincipal investigator8072252679drsairagavi@gmail.com