Nirvana Super Pro Supplementation in Orthopedic Surgery Patients

Launched by NIRVANA WATER SCIENCES CORP · Jan 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how two dietary supplements, called PREPARE and RECOVER, might help patients recover after undergoing total hip or knee replacement surgeries. The goal is to see if these supplements can improve recovery times for people with knee or hip joint issues. The study is currently recruiting participants aged between 45 and 80 who are scheduled for these surgeries and are in good overall health, without serious conditions like liver or kidney disease, uncontrolled high blood pressure, or certain bone disorders.

If you or a loved one are interested in participating, you should be free of any serious medical illnesses and willing to take the supplements for 28 days before the surgery. It's important to note that individuals with osteoporosis or certain other health issues, like a high body mass index, won’t be eligible. Participants will be monitored throughout the study, and this could be a great opportunity to contribute to research that might help others in similar situations in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female subjects will be enrolled into the study.
• • Age ≥45-80 years.
• • Free of liver and kidney diseases, and with no evidence of uncontrolled hypertension.
• • Does not have a chronic disease that affects calcium or bone metabolism (i.e., asthma with chronic use of high dose steroids, inflammatory bowel disease, Crohn's disease, primary hyperparathyroidism, seizure disorder with use of phenobarbital, etc.).
• • Not classified as morbidly obese (body mass index (BMI) \>43 kg/m2).
• • Six weeks since major surgery (three weeks since minor surgery).
• • Total joint replacement is not a revision of previous joint replacement.
• • Willing to consume dietary supplements for the study period.
• • Individuals diagnosed with osteoporosis, or a bone density \>2.0 standard deviations below the mean, will not be enrolled in the study.
• • No other serious medical illness.
• • Physicians have placed no restriction on physical exercise.
• • Patient is scheduled for a total knee or hip replacement and agrees to consume the 28-day pre-operative regime.
• Exclusion Criteria:
• • Evidence of liver and kidney diseases, uncontrolled hypertension, or Type I or II diabetes mellitus requiring insulin for glucose control.
• • The presence of a chronic disease that affects calcium or bone metabolism (i.e., asthma with chronic use of high dose steroids, inflammatory bowel disease, Crohn's disease, primary hyperparathyroidism, seizure disorder with use of phenobarbital, etc.).
• • Classified as morbidly obese (body mass index (BMI) \>43 kg/m2).
• • Less than six weeks since major surgery or three weeks since minor surgery.
• • Surgery is a revision of a previous total joint replacement.
• • Not willing to consume nutritional supplements for the study period.
• • Individuals diagnosed with osteoporosis, or a bone density \>2.0 standard deviations below the mean, will not be enrolled in the study.
• • Other serious medical illness, which the subject's doctor or medical review team has decided affects the subject's ability to participate in the study. For example, pathological hip fracture or cancer disease in active phase or undergoing treatment (radiotherapy or chemotherapy).
• • History of blood clots and/or the use of blood thinning medications
• • Subjects on high dose vitamin D therapies (i.e., 50,000 IU vitamin D).