Health Condition 1: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Intervention1: Curcumin (35 % curcuminoids)capsule: K. PATEL Phyto Extractions Pvt. Ltd.
Village Talwada, Behind Old Sales Tax check Post,
NH-8, Bhilad,
Taluka: Umergaon, District: valsad,
Gujarat- 3
Sponsors
KPATEL Phyto Extractions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male and Female Volunteers between 18 to 60 years. Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for three consecutive months for more than two consecutive years). Score greater than or equal to 3 points on the cough severity score Subjects having low immunity by testing the immunoglobin antibody (IgG and total IgM & IgE) Subjects who have not participated in a similar investigation in the past four weeks. Subjects able to provide informed consent. Subject is willing and able to comply with all trial requirements
Exclusion criteria
Exclusion criteria: Pregnancy or risk of pregnancy Subjects who are on ACE inhibitor drugs Subjects having history of GERD Patients with asthma COPD pneumonia will be excluded from the study Any pathology or past medical condition that can interfere with this protocol History Presence of the following diseases (like cholangitis pancreatitis etc) or uncontrolled severe organ disorders Severe neurological or psychological disorders or a history of alcohol or drug abuse of allergic reaction to the medications used in the study Use of other investigational drugs within 30 days prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significant Reduction in sign and symptoms chronic bronchitis from baseline to EOT Improvement in Immunity Total IgG and total IgM and IgE to see improvement in immunity from baseline to end of treatment Timepoint: screening and end of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Chest X-ray analysis from baseline to end of treatment. â?¢ Safety assessed by Adverse Events Timepoint: All visits;Chest X ray analysis from baseline to end of treatment. Safety assessed by Adverse Events.Timepoint: Screening to end of treatment;Chest X ray analysis from baseline to end of treatment Safety assessed by Adverse Events Timepoint: Screening to end of treatment | — |
Countries
India
Contacts
Public ContactDr Harisha S
ICBio Clinical Research Pvt Ltd
Outcome results
None listed