None listed
Conditions
Interventions
Intervention1: CIT: CIT is a tablet composed of formulation Triphala Guggul and herbs like Tinospora cordifolia, Curcuma longa, Rubia cordifolia, Plumbago zeylanica, Piper longum, Piper nigrum and Zin
Sponsors
Charak Pharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Individuals of either sex in the age group 18-35 years 2.Individuals ready to abide by trial procedures and give written informed consent
Exclusion criteria
Exclusion criteria: 1.Individuals with known history of usage of herbal medications/ nutritional supplements/ multivitamin supplements/ pre and probiotic supplementation/ available market medications for immunity within past 30 days for any indication. 2.Individuals with known history of thyroid disorders, cardiac, liver or renal pathologies. 3.Pregnant and lactating females 4.Haemoglobin 5.Liver function tests > 2.5 times the upper normal limits 6.Renal function tests > 1.5 times the upper normal limits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.10% more improvement in innate immunity assessed as Interferon (IFN gamma) in CIT group as compared to placebo group 2.10% more increase in proportion of cells involved in cell mediated immunity viz. CD4 and CD8 in CIT group as compared to placebo group 3.10% more increase in functional capacity of Mononuclear cells in CIT group as compared to placebo group 4.10% more improvement in perceived stress and quality of life in CIT group as compared to placebo group Timepoint: Baseline, 4 weeks and 8 weeks- IFN gamma, perceived stress, quality of life Baseline and 8 weeks- CD4, CD8 counts and functional capacity | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.10% more improvement in anti-oxidation status of red blood cells in CIT group as compared to placebo group 2.Safety of the study drug throughout the study Timepoint: Baseline and 8 weeks- Anti-oxidation status of red blood cells in CIT group as compared to placebo group Screening and 8 weeks- Safety of the study drug | — |
Countries
India
Contacts
Public ContactSupriya Bhalerao
Interactive Research School for Health Affairs, Bharati Vidyapeeth Deemed to be University
Outcome results
None listed