None listed
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Healthy male and female volunteers in the age group 18-45 years. In case of female, 48 hours after menses stop BMI- 18.5- 24.9 kg/m2 Participants devoid of any acute or chronic diseases as determined by medical history, physical examination and laboratory tests. BMI In the range of 18.5 to 24.9 kg/m2 Participants deemed fit for Vamana Karma, as per Ayurveda classical texts. Willing to participate for a period of 06 months and adhere to the study interventions and advocacies throughout the intervention period
Exclusion criteria
Exclusion criteria: Any known co-morbidity or acute illness with or without symptoms as assessed by clinical examination and history Participation in any clinical trial in the last 3 months Elevated liver enzymes over 1.5 times the normal range for AST, ALT or GGT Evidence of chronic renal disease as defined by estimated glomerular filtration rate of less than 60 ml/min. Diagnosis of anemia (defined as hemoglobin less than 8.9mg/dl), or any nutritional disorder as evident from laboratory investigations and history History or evidence of active or latent TB History of Endocrine disorders, such as Cushing s disease, pituitary disorders, and hypo- and hyperthyroidism History of any Behavioral or psychiatric conditions that would affect participation in the study Use of any nutritional supplement, antibiotics, antacids or probiotic agents within 3 months of the initiation of study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the Gut and oral microbiota composition assessed through qPCR and 16S rRNA amplicon sequencing and metabolite profiling by liquid chromatography-mass spectrometryTimepoint: Day 0, Days 3, Day 6/8/10, Day 8/10/12, Day 11/15/19, Day 30, and Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Complete Hemogram, Lipid profile, LFT, RFT, Bicarbonate, Fasting InsulinTimepoint: Day 0, after Snehpana, after Vamana, Day 180);Change in HbA1C, homeostatic model assessment to quantify insulin resistance (HOMA-IR), Vit B12, Vit DTimepoint: Day 0, Day 180;Change in Fasting GlucoseTimepoint: Day 0, After Vaman, Day 180;Change in fasting adiponectin and leptinTimepoint: Days 0, 30, 60 and 180;Change in urine metabolome from baselineTimepoint: Day 0, after Snehana, after vamana, Day 30;Change in urine F2-isoprostanes as a biomarker for oxidative stress by specific ELISA testTimepoint: Day 0, Days 3, Day 6/8/10, Day 8/10/12, Day 11/15/19, Day 30, and Day 180;Change in Quality of Life assessed through SF-36Timepoint: Baseline, Days 30, 60, 180;Reported AE/ADRTimepoint: Participant reported AE/ADR recorded in structured formats | — |
Countries
India
Contacts
Public ContactDr Renu Rani
Central Ayurveda Research Institute
Outcome results
None listed