Status:
UNKNOWN
Study of Efficacy and Safety of the Plasmapheresis Method With Albumin Compensation Compared With the Plasmapheresis Method Without Albumin Compensation for Aging Biomarkers Correction in Men and Women Aged 40 to 55 Years Old
Lead Sponsor:
National Medical Research Center for Rehabilitation and Balneology
Collaborating Sponsors:
The Orenburg Regional Clinical Hospital
DNKOM LLC
Conditions:
Hypercholesterolemia
Hyperbilirubinemia
Eligibility:
All Genders
40-55 years
Phase:
NA
Brief Summary
Reaching active aging makes it important to implement new methods affecting the biological age of a person. Biochemical parameters of a blood test are aging biomarkers that are ones of the most access...
Detailed Description
Reaching active aging makes it important to implement new methods affecting the biological age of a person. Biochemical parameters of a blood test are aging biomarkers that are ones of the most access...
Eligibility Criteria
Inclusion
- Signed informed consent form.
- Men and women aged 40-55.
- Body mass index \<30 kg / m2.
- Level increase of one or several aging markers.
- Understanding of requirements for study participants, written consent to participate in the study (including volunteer's consent for his/her health information related to the study to be used and passed on) and to perform procedures outlined in study protocol.
- Negative pregnancy test for women of childbearing potential.
- Non-inclusion Criteria:
- Refusal to participate in the study.
- Any health conditions that, according to investigators, might prevent volunteers from participating in the study.
- Mental disorders, past medical history included.
- 10 + alcohol units per week (one alcohol unit equals 0,5 l of beer, 200 ml of wine or 50 ml of hard liquors) or any records of alcohol addiction.
- Drug addiction, chemical abuse.
- Pregnancy or breastfeeding.
- Past medical history of severe allergic reactions.
- General contraindications to plasmapheresis procedures.
- Any other health conditions or reasons that, according to investigators, might increase risks for participants or reduce the likelihood of results needed to meet the study goals.
Exclusion
- Voluntary refusal to participate in the study.
- Investigator doctor's decision on participant's exclusion for this participant's own benefit.
- Participant refuses to cooperate with investigator or is undisciplined.
- In case participant misses one or several study procedures or follow-up visits.
- Development of severe adverse reactions or severe diseases/conditions unrelated to the study, requiring withdrawal from therapy.
- Positive pregnancy test.
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04897113
Start Date
May 12 2021
End Date
December 30 2022
Last Update
May 21 2021
Active Locations (2)
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1
Federal State Budgetary Institution "National Medical Center for Rehabilitation and Balneology" of the Ministry of Health of Russia
Moscow, Russia, 121099
2
Orenburg regional clinical blood transfusion station
Orenburg, Russia, 460018