28-Day Clinical Study by AMA Labs
AMA Laboratories 216 Congers Road, Bldg 1 New City, NY 10956 USA
28 DAY JOINT RELIEF STUDY
AMA Ref. No: MS13.QUEST.M9600.REPD28.GKL
Sponsor: Greek Island Labs LLC - Scottsdale, Arizona
This panel has been convened to evaluate the test formula intended to reduce joint pain and improve flexibility and range of motion in the joints. Pain relieving properties were evaluated using VAS (Visual Analog Scale) scoring method (0~10 scale).
Test Sample Description:
On April 15, 2013 test samples labeled Natural Joint (R) Dietary Supplement were received from Greek Island Labs LLC and assigned AMA Lab No. M-9600.
Upon arrival at AMA Laboratories, Inc., the test material is assigned a unique laboratory code number and entered into a daily log identifying the lot number, sample description, sponsor, date received and test requested.
Samples are retained for a period of three months beyond submission of final report unless otherwise specified by the sponsor or if sample is known to be in support of governmental applications, in which case retained samples are kept two years beyond final report submission.
Sample disposition is conducted in compliance with appropriate federal, state and local ordinances.
Test Material Evaluation Prerequisite:
Prior to induction of a human test panel, toxicology, microbiology or in-vitro performance spectra may be required to assess the feasibility of commencement as dictated by an Institutional Review Board (IRB) described in Section 3.0
Sponsor purports that prior to sample submission to AMA the samples were received and approved by the Sponsor’s Safety Group for inclusion in this protocol.
Institutional Review Board:
Reference CFR Title 21 Part 56, Subparts A, B, C, and D. The IRB of AMA Laboratories, Inc. Consists of 5 or more individuals, chosen from within the company for technical expertise and from the local community for lay interaction. The list of IRB members is kept on file at AMA Laboratories, Inc., and is available for inspection during the hours of operation.
Standard for Inclusion in a Study:
1. Males and Females actively experiencing joint pain.
2. Individuals who will complete a preliminary medical history and screening document as mandated by AMA Laboratories, Inc.
3. Individuals, who will read, understand, and sign and informed consent document as required by CFR Title 21, Part 50, Subpart B regulations. Consent forms will be kept on file and are available for examination on the premises of AMA Laboratories, Inc., only.
4. Individuals in general good health and free of any health problems, including neurological, dermatological, or systemic disorder that would interfere with the results, at the discretion of the Study Director.
5. Individuals who will abstain from using any pain relief products or supplements at least 48 hours prior to the test period.
6. Individuals able to cooperate with the investigator and research staff, willing to have the test material(s) applied according to the protocol, and complete the full course of study.
Standard for Exclusion from a Study:
- 1. Individuals who are under the care of a physician.
- 2. Individuals currently taking medication that may mask or interfere with the test results.
- 3. Individuals diagnosed with chronic skin allergies.
- 4. Females who are pregnant, lactating, have been pregnant, or given birth within the six month period immediately preceding study commencement.
- 5. Subjects with a history of any form of skin cancer, melanoma, lupus, psoriasis, connective tissue disease, diabetes, or any disease that would increase the risk associated with study participation.
- 6. Individuals with irritation or sensitivity to lotion products.
- 7. Individuals with known allergies or skin conditions, which would interfere with the study at the discretion of the Study Director.
Panel selection is accomplished by advertisements in local periodicals, community bulletin boards, phone solicitation, electronic media or any combination thereof.
Informed Consent Document:
An informed consent was obtained from each volunteer prior to initiating the study describing reasons for the study, possible adverse effects, associated risks and potential benefits of the treatment and their limits of liability. Panelists signed and dated the informed consent document to indicate their authorization to proceed and acknowledge their understanding of the contents. Each subject was assigned a permanent identification number and completed an extensive medical history form and screen form. These forms, along with the signed consent forms, are available for inspection on the premises of AMA Laboratories, Inc, only. Reference 21 CFR Ch.1 Part 50, Subpart B.
- 1. Subjects were mandated to adhere to all the restrictions mentioned in the inclusion/exclusion section (refer to Section 4.1 and 4.2).
- 2. Upon arrival to the laboratory panelists were examined by a trained technician.
- 3. Based on an interview with panelist, one test site with joint pain was selected.
- 4. Panelists were asked to rate the pain on a Visual Analog Pain Rating Scale at Baseline and again after 5, 14 and 28 days of use according to the sponsor supplied label instructions. Similar grading scales were additionally employed to grade joint flexibility and range of motion.
Please refer to attached Table. Observations: No adverse affects or unexpected reactions of any kind were observed on any of the subjects.
All original samples, raw data sheets, technician’s notebooks, correspondence files, copies of final reports and remaining specimens are maintained on the premises of AMA Laboratories, Inc. In limited access marked storage files. A duplicate DVD copy of final reports is separately archived in a bank safe deposit vault.
Within the limits imposed by the conduct and population size of the study described her in, the test material (AMA Lab No.: M-9600; Client No.: Natural Joint (R) Dietary Supplement when used in accordance, demonstrated statistically significant reduction in joint problems by an average of 82.2% within the first 28 days of treatment with a maximum of 100% observed. Statistically significant improvements in joint mobility averaging 79% and flexibility averaging 76.9% were also observed. Further, these phenomena were documented and confirmed during the course of the study.
Quality Assurance Statement:
This study was inspected in accordance with the Standard Operating Procedures of AMA Laboratories, Inc. To assure compliance with the study protocol, the Quality Assurance Unit completed an audit of the study records and report.
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