None listed
Conditions
Interventions
Intervention1: Capsule PHP-TB containing hydro-alcoholic extracts of Withania somnifera 300mg: Will receive a combipack containing Tab. Isoniazid(H) 600mg +Cap. Rifampicin (R) 450mg + Tab. Pyrazinam
Sponsors
Government Medical College, Jammu
Indian Institute of Integrative Medicine, Jammu
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients between 25-50 yrs. of age of either sex, 2. Newly diagnosed untreated patients of pulmonary tuberculosis.
Exclusion criteria
Exclusion criteria: 1. Extra pulmonary cases of tuberculosis. 2. History of chronic alcohol intake or smoking. 3. HIV Positivity, diabetes mellitus, autoimmune disease, Hepatitis B. 4. Pregnancy and lactation. 5. Has participated in any investigational study 4 weeks prior to the enrollment in this study. 6. Known history of hypersensitivity reactions. 7. Confirmed or suspected immunosuppressive or immune deficient condition. 8. Family h/o congenital or hereditary immunodeficiency 9. Chronic administration of immunosuppressants or other immune modifying agents 6 months prior to the study. 10. Administration of immunoglobulins 3 months preceding the enrollment in the study. 11. Patients with impaired hepatic functions. 12. Patients with impaired renal functions. 13. Seizure disorder 14. Patients with known symptoms of cardiac disease like Coronary artery disease, arrhythmias.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The patients will be evaluated for various parameters like weight gain, improved QOL , sputum for AFB , X-ray chest ,Elisa for TNF - α and IL-1β and flow cytometry for various immune parameters like IFN-Ύ, IL-2, CD3+, CD4+, CD8+.Timepoint: 8 weeks onwards | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactDr. Inshad Ali Khan
Professor& Head, Post graduate department of Pharmacology and Therapeutics
Outcome results
None listed