Clinical trial: A Study to Investigate the Efficacy of Pain Bloc-R in Healthy Participants With Non-pathological Aches and Discomfort (NCT03965819)

Eligibility criteria:
Inclusion Criteria:

          1. Males and females 18-65 years of age, inclusive

          2. BMI of 18-32.5 kg/m2, inclusive

          3. Individuals with occupational (construction workers, manual labourers, athletes) and
             non-occupational unresolved aches and discomfort for at least 2 weeks

          4. Individuals on non-prescription, OTC medication for unresolved aches and discomfort
             and are willing to undergo a washout determined by the QI based on dose and frequency
             prior to enrollment

          5. Female participants not of child bearing potential, defined as females who have had a
             hysterectomy or bilateral oophorectomy, bilateral tubal ligation, total endometrial
             ablation or are post-menopausal (natural or surgically with > 1 year since last
             menstruation) or, Females of childbearing potential must agree to use a medically
             approved method of birth control and have a negative urine pregnancy test result. All
             hormonal birth control must have been in use for a minimum of three months. Acceptable
             methods of birth control include:

               -  Hormonal contraceptives including oral contraceptives, hormone birth control
                  patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable
                  contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)

               -  Double-barrier method

               -  Intrauterine devices

               -  Non-heterosexual lifestyle or agrees to use contraception if planning on changing
                  to heterosexual partner(s)

               -  Vasectomy of partner at least 6 months prior to screening

          6. Healthy as determined by laboratory results and medical history as assessed by the QI

          7. Willingness to complete questionnaires, records, and diaries associated with the study
             and to complete all clinic visits

          8. Agrees to comply with study procedures

          9. Has given voluntary, written, informed consent to participate in the study

        Exclusion Criteria:

          1. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial

          2. Anticipated problems or allergy to any ingredients in the investigational products

          3. Allergy to rescue medication

          4. Have chronic disease conditions causing chronic pain

          5. Uncontrolled high and low blood pressure

          6. Uncontrolled blood sugar levels

          7. Clinically significant abnormal laboratory results at screening

          8. Prescribed medications used to help with aches and discomfort (Section 7.3.1)

          9. OTC medications and supplements taken to help with aches and discomfort (Section
             7.3.2)

         10. Autoimmune disease or if immune-compromised (i.e. HIV-positive, use of anti-rejection
             medication, rheumatoid arthritis, Hepatitis B/C-positive)

         11. Cancer, except skin cancers completely excised with no chemotherapy or radiation with
             a follow-up that is negative. Volunteers with cancer in full remission for more than 5
             years after diagnosis are acceptable after review by QI

         12. History of mental illness that might impair the ability of participants to provide
             written informed consent

         13. Current or history of bleeding disorders

         14. Current or history of liver or kidney disease as assessed by QI on a case by case
             basis.

         15. Current or pre-existing unstable thyroid condition. Treatment on a stable dose
             medication for over one year will be reviewed on a case-by-base basis by the QI

         16. Surgical procedures which may impact the study outcomes within the past 3 months to be
             assessed by the QI

         17. Medicinal marijuana

         18. Recreational marijuana; dose and frequency to be assessed by QI

         19. Alcohol intake >2 standard drinks per day or >10 standard drinks per week

         20. Illicit drug use in the past 6 months as assessed by the QI

         21. Participation in clinical trials within 30 days prior to screening visit

         22. Blood donation during or within 30 days after conclusion of clinical trial

         23. Any other active or unstable medical condition, that, in the opinion of the QI, may
             adversely affect the participant's ability to complete the study or its measures or
             pose significant risk to the participant.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Entailment