Health Condition 1: J984- Other disorders of lung
Conditions
Interventions
Intervention1: C3Reduct: One tablet two times a day (b.i.d), after breakfast and
dinner for 90days
Control Intervention1: Placebo: One tablet two times a day (b.i.d) after breakfast and dinn
Sponsors
SamiSabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and/or female subjects aged between 21 to 70 years (both inclusive) with valid age proof. 2.FVC % between 65% to 80% 3.Previous diagnosis of pulmonary fibrosis (within 1 year of study participation), made by a respiratory physician based on International Classification of Diseases (ICD-10). 4.No participation in another clinical study in last 90 days. 5.Able to give written informed consent. 6.Voluntary participation and not coerced. 7.Willing to come for regular follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Planned any surgery during the trial participation, (including lung, abdominal or intestinal surgery). 2.With prior lung transplantation. 3.History of drug or alcohol abuse within 3 months of enrolment to the study. 4.History of smoking within 30 days of enrolment to the study. 5.Any condition that may compromise patient safety. 6.Pregnant / lactating woman. 7.History of stroke and transient ischemic attack within 6 months of enrolment to the study. 8.Patients with acute IPF exacerbation or any respiratory tract infection in the four weeks prior. 9.Uncontrolled systemic hypertension (SBP > 180 mmHg; or DBP > 100 mmHg). 10.Diagnostic history of myocardial infarction, Severe chronic heart failure, Angina, Arrhythmias before 6 months of enrolment to the study. 11.History of immunocompromised status. 12.Impaired liver and renal functions (defined as Aspartate Amino Transferase (AST) and/or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) >2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL for females or >1.4 mg/dL for males and EGFR of 60 or less). 13.Subjects with evidence of malignancy. 14.History of any psychiatric disorders like Schizophrenia or Bipolar disorder. 15.History of hypersensitivity to any of the herbal extracts or dietary supplement. 16.Patients currently on corticosteroids. 17.Patients on prolonged ( > 4 weeks) medication with antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 18.Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of C3Reduct Blend on pulmonary function test ( spirometry)Timepoint: 1.Mean change in pulmonary function test (From screening to final visit) a)Forced vital capacity (FVC) b)Absolute FEV1 /FVC ratio (Tiffeneau-Pinelli index) 2. Mean change in 6 minutesâ?? walk test from baseline to final visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the efficacy of C3Reduct Blend on other anti-inflammatory effect, physical and mental health. 2.To evaluate the safety of C3Reduct Blend Timepoint: 1.Mean Change in Inflammatory markers â?? IL-6, hs-CRP (Baseline to final visit) 2.Mean change in SF-36 (RAND)score (Baseline to final visit) 3.Mean change in WHOQOL-BREF score (Baseline to final visit) 4.Safety upon the occurrence of adverse events (Baseline to final visit & Telephonic follow-up) | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
Sami-Sabinsa Group limited
Outcome results
None listed