None listed
Conditions
Interventions
None listed
Sponsors
Amaara Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female participants 18 years and above 2.BMI between 18.5 and 24.9 kg per m2 (both inclusive)3.Apparently mentally and physically healthy and biochemical parameters within normal reference ranges 4.Willingness to complete the study interventions and follow up 5.Participants with normal cardiovascular function with no evidence of acute ischemic heart disease in the electrocardiogram 6.The participant is willing to provide consent and visit on follow up and abide by protocol related requirements.
Exclusion criteria
Exclusion criteria: 1.Being on medically prescribed or over the counter supplements 2.Pregnant and lactating women 3.Reported weight loss or gain greater than 10 percent of body weight in the 6 months preceding pre-study examination 4.Undergoing medical treatment that may interfere with the study outcome 5.Participants with a diagnosis of an active disease and or receiving pharmacological treatment prescribed for an active disease and who have evidence of an active disease at the time of the initial clinical examination at the discretion of the investigator 6.Any other major clinical disease or psychiatric disorder that at the discretion of the investigator, precludes the administration or completion of the protocol treatment. 7.Participants with any significant comorbid condition or currently undergoing pharmacological treatment, which in the investigators judgment may interfere with the clinical trial outcomes. 8.Recreational drug use during the past 6 months 9.Participants with a history or presence of significant alcoholism or drug abuse within the past 1 year. 10.Participants with a history or presence of significant smoking more than 10 cigarettes per day or consumption of tobacco or nicotine products more than 10 times per day. 11.Participation in another clinical trial within the last 3 months. 12.Known hypersensitivity to any of the ingredients of an investigational product 13.Participants consuming any nutraceutical, herbal, or ayurvedic supplement for any other condition 14.Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objectives of the study will be to evaluate the safety of the TruBlkTM Shilajit Resin in healthy male and female adults.Timepoint: screening to end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| The endpoint of the study will be to assess changes in - 1.Clinical laboratory examination of complete blood count (CBC), lipid profile, thyroid profile, liver function test (LFT), kidney function test (KFT), urine analysis, serum potassium, chloride, sodium, CRP, and fasting blood glucose. 2.Observations in X-ray and ECG. 3.Changes in the gastrointestinal symptom rating scale (GSRS) score. 4.Vital signs. 5.Tolerability and compliance using diary of the investigational product. 6.Assessment of adverse events. Timepoint: 1. screening, day 15 and day 31. 2. screening and day 31. 3. screening and day 31. 4. screening, baseline, day 15, and day 31. 5. day 15 and day 31. 6. baseline, day 15, and day 31. | — |
Countries
India
Contacts
Public ContactAmandeep Singh
Amaara Ayurveda
Outcome results
None listed