None listed
Conditions
Interventions
Intervention1: Virechana with Trivrit levy 50gms orally on last day of virecana once. Guduchi ghoorna 3 gms bid orally for 3 to 5 days till deepen pachana laxanas observed, Cow ghee (goghrita) up to 2
Sponsors
Central Council of Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy female subjects and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy individual are screened based on the proforma (CRF) of Ayurvedic parameters of health as well as detailed medical history for identifying no clinically relevant abnormalities, full physical examination, including BP and pulse rate measurement, 12-lead ECG, or clinical laboratory tests. 2. Body mass index (BMI) 3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 4. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic (including alcoholic liver disease, non-alcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver diseases), psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). 2. Evidence or history of clinically significant dermatological condition (e.g. contact dermatitis or psoriasis) or visible rash present during physical examination. 3. History of regular alcohol consumption within 6 months before screening. 4. Participation in any clinical trial in the last 3 months which if the investigator seems prudent to be considered an exclusion criteria and many other (due to words limit all exclusion criteria not added)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prim: Changes in the gut microbial profile.Timepoint: 18 days to 26 days of intervention with follow up of 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in the body composition (muscle mass, fat mass). 2. Changes in the resting metabolic rate (RMR). 3. Changes in the lipid profile, complete blood count, serum insulin, blood sugar levels, thyroid profile, liver function tests, kidney function tests, ghrelin, leptin, IgE, Vit B12, Vit D, IFN-gamma,TNF-α, IL-1β, glutathione levels, complement protein C3-C4. 4. Changes in the Oja assessment BODE index, SF36 and pain and fatigue score. 5. Change in Agni assessment ScaleTimepoint: 18 days to 26 days of intervention with follow up of 3 months | — |
Countries
India
Contacts
Public ContactVittal Huddar
All India Institute of Ayurveda
Outcome results
None listed