Health Condition 1: R50-R69- General symptoms and signs
Conditions
Interventions
None listed
Sponsors
Dr A Venkata Swamy
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 25 years & above and of 40 years & below. 2. Subjects who are diagnosed with general debility as per the clinical study investigator 3. Subject or Legally acceptable representative of subject willing to sign an Informed Consent Form indicating that they understand the purpose of and the procedures required for the trial and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant, planning to become pregnant or breastfeeding women. 2. Subjects with significant medical/surgical condition which requires long-term treatment. 3. Subjects with compromised immune system (HIV positive, organ transplant recipients, cancer patients etc.,) 4. Subjects with significant/advanced co-morbid conditions such as Hypertension, Diabetes, Heart disease, Chronic lung/liver/ kidney disease, Cerebro-vascular disease etc., 5. Subjects who have in the past 3 months suffered with COVID-19 infection. 6. Subjects who are currently being treated with other immunostimulant drugs. 7. Alcohol or substance abuse 8. Allergy or sensitivity to any of the ingredients in the study treatment 9. Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in signs and symptoms of General Debility (Stress, Strength, Stamina, Immunity, Fatigue etc.,) as recorded through 5-point Likert scale based assessment questionnaire as compared to baseline at day 30Timepoint: Baseline and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in quality of life as assessed through SF-36 questionnaire as compared to baseline at day 30Timepoint: Baseline and Day 30;Laboratory Assessment â?? Serum Creatinine and Liver Function Test at Baseline and Day 30Timepoint: Baseline and Day 30;Number of adverse events (AE) or serious adverse events (SAE), either spontaneously reported by the subject, or noticed by the clinician will be recorded during the study - between the groups comparisonsTimepoint: Entire Study;Physician global satisfaction with treatment as recorded using 5-point Likert scale at day 30Timepoint: Day 30;Subject global satisfaction with treatment as recorded using 5-point Likert scale at day 30Timepoint: Day 30;The safety in terms of vital signs of the subjectsTimepoint: Entire Study | — |
Countries
India
Contacts
Public ContactDr A Venkata Swamy
Holistic Healthcare and Research Centre
Outcome results
None listed