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You are invited to participate in a research study to evaluate the effectiveness of cannabidiol (CBD) to provide joint support for your canine. This study is being sponsored by Panacea Life Sciences and is led by James W. Baumgartner, Ph.D. We ask that you read through this information and ask any questions prior to agreeing to participate in this study.

*The words “dog”, “canine”, and “patient” are used interchangeably throughout this study information.

 

Study Summary: Proposal for the use of cannabidiol (CBD) as a supplement for supporting joint health in dogs experiencing age-related movement disorders.

 

Study Title: Evaluation of CBD in Canine Age-Related Movement Disorders

 

Background and Purpose: Panacea Life Sciences is launching an open label study to evaluate the ability of cannabidiol to help dogs with age-related movement disorders. Like man, things like exercise and aging can create muscle soreness and stiff joints, making it painful to move. Especially in recent years, numerous claims have been made regarding CBD’s ability to help with various canine health issues including pain, anxiety, and overall health. Instead of simply making claims, Panacea is dedicated to providing consumers with evidence-based data and information about whether CBD truly improves specific health conditions.

Using evidence from this study to generate more detailed information, Panacea will build upon its initial 2019 study to further evaluate CBD’s ability to support joint health and movement in dogs that have observable movement issues. Patients/owners enrolled in the study, which will take place over the course of two weeks, will receive – free of charge – two bottles of Panacea Life Sciences’ Canine CBD Softgels.

*Note: All Panacea Pet CBD products, including the test product used in this study, are THC-Free.

 

Study Objectives:
1. Evaluate the efficacy of the test product (CBD) as an option for management of pain in patients who have movement-related disorders, limited mobility, or a diminished quality of life secondary to osteoarthritis.
2. Assess the tolerance, ease of administration, and potential for side effects associated with administration of the test product (CBD).

*Note: We are evaluating this product in stages to determine how it can be best utilized to improve the quality of life of patients with the aforementioned conditions, whether as a sole agent or as an adjunct to more traditional therapies.

 

Eligible Participants:

All dogs, regardless of size, sex, or breed are eligible to enroll in the study as long as they…

• are not currently taking CBD products, and
• display an observable movement issue(s) (whether it be a limp in gait or trouble climbing stairs or getting into cars, etc.)

 

Study Procedures:

STEP 1: Submit information

• Complete the Patient Consent Form (button located at bottom of page)
• Fill out the Initial Survey: Canine Pain Inventory (button located at bottom of page)
• Optional: Please record and submit a short (10-90 second) video showing observable movement issues of your dog. Send an email to [email protected] including your dog’s name, your name, and the video as an attachment.

STEP 2: As soon as Panacea receives your submitted items from Step 1, Panacea will ship to you 1 bottle of our Canine CBD Softgels (free of charge). You may choose whatever 2-week trial period (14 consecutive days) is most convenient for you to administer the test products, but we ask that you plan to complete the study and submit the follow-up survey by Monday, March 13, 2023.

STEP 3: Begin the 2-week trial period

• Administer 1 softgel to your dog TWICE DAILY (once in the morning and once in the evening) for 14 consecutive days.

**Note: During the trial period, patients should continue on any medications or therapies, but we ask that these be reported in the surveys. Since this study is observational and relies on the systemized feedback from pet owners, we ask that no procedures will be performed on any patient during the study period.

STEP 4: Submit follow-up information

• Fill out the Follow-Up Survey: Canine Pain Inventory
• Optional: Please record and submit a short (10-90 second) video showing general movement of your dog – especially to show any improvements in their mobility. Send an email to [email protected] including your dog’s name, your name, and the video as an attachment.

STEP 5: Once we receive your submitted items from Step 4, Panacea will ship to you an additional full-size bottle of Canine CBD Softgels AND a full-size bottle of our human FAST CBD Tablets for FREE. Additionally, you’ll receive a Promo Code to receive an extra 10% discount for every order when you sign up for an automatic monthly subscription of Panacea’s Canine CBD Softgels, which is a total of 40% off! (Monthly subscribers normally receive a 30% discount and free shipping.)

 

Benefits of Study Participation:
The benefits to study participation may include but are not limited to:

1. Gaining a more comprehensive understanding of how the test product may be used to manage osteoarthritis and/or movement issues while minimizing the potential for undesirable side effects.
2. A patient’s improved mobility, agility, and overall quality of life due to pain relief provided by the test product.
3. Establishing CBD as an adjunct to current standards of care relating to the treatment of patients with osteoarthritis or movement issues.
4. Free Panacea CBD products!

 

Risks of Study Participation: During the course of the study, patients may experience diarrhea, vomiting, or lethargy. While other undesirable side effects may occur, the dose of CBD used in this study is well below doses used in prior studies that established safe and tolerable dosing guides. As a consequence, should any of the aforementioned side effects occur, they should be self-limiting or resolved entirely with a minimum amount of intervention by your family veterinarian. Please note: all Panacea Pet CBD products, including the test product used in this study, are THC-Free. Patients participating in the study who have been receiving other therapies may observe differences in their pet relative to the prior therapy. Please feel free to discuss any concerns with your family veterinarian or the lead investigator at any time.

 

Study Costs/Compensation: Participating owners will be provided the test product for the duration of the study period at no cost, and the test product will be shipped directly to participants. Therefore, there are no direct costs to participating owners in this study. In the unlikely event of side effects associated with this product, participants will be responsible for any veterinary costs incurred during or after the study period to treat perceived or actual side effects. As thanks for participation, owners that complete the study and requested feedback will not only receive an additional full-size bottle of Canine CBD Softgels AND a full-size bottle of our human FAST CBD Tablets for FREE. Additionally, you’ll receive a Promo Code to receive an extra 10% discount for every order when you sign up for an automatic monthly subscription of Panacea’s Canine CBD Softgels, which is a total of 40% off! (Monthly subscribers normally receive a 30% discount and free shipping.) Product subscriptions are completely optional and not required for study participation.

 

Confidentiality: Information about your pet may be used in scientific presentations and/or publication. If participating, Panacea Life Sciences reserves the right to utilize images, videos, testimonials, and/or reported information of/about your dog for reporting or marketing purposes to demonstrate product effectiveness. Aside from your dog’s first name (unless specifically requested otherwise*), NO PERSONAL OR IDENTIFYING INFORMATION ABOUT YOU OR YOUR DOG WILL BE RELEASED.

*To request that Panacea does NOT use your dog’s name, please contact us at 1(800)-985-0515 or at [email protected].

 

Voluntary Participation: Participation in this study is voluntary. Your decision whether to participate in this study will not affect your current or future relations with Panacea or your veterinarian. If you decide to participate, you are free to withdraw at any time.

 

Please do not hesitate to contact us if you have any questions or concerns about this study.

Panacea Life Sciences

Phone: 1(800)-985-0515

Email: [email protected]

 

Primary Investigator: Dr. James Baumgartner

Office phone: 720-639-6174

Email: [email protected]

 

CANINE JOINT SUPPORT PATIENT CONSENT FORM

CANINE BRIEF PAIN INVENTORY: INITIAL SURVEY