carticol ®

®

Aix Scientifics^® Clinical Research Organisation

carticol^® - Study
Participants wanted
The effectiveness of the dietary supplement carticol^® is examined. The manufacturer, Ten Kate Health Supplements B.V. (10kate.com), is conducting this study to show that carticol^® is effective in relieving pain and improving the functional status in knee osteoarthritis (OA, osteoarthrosis).
If you are over 30 years old and suffer from osteoarthritis of the knee, we would like to invite you to take part in this study.

Product information
carticol^® is developed as a nutritional supplement to support joint function and bone health. carticol^® contains non-denatured collagen type II (T2NDC^®) as an important component.

	components	2 capsules	%NRV *
	Vitamin C (Ascorbic acid)	200 mg	250 %
	Vitamin D	5 mg	100 %
	Vitamin E (D-alpha-Tocopheryl acetate)	10 mg	83 %
	Manganese	1.5 mg	75 %
	Methylsulfonylmethan (MSM)	300 mg
	Non-denatured type II collagen	160 mg
	Hyaluronic acid	15 mg
	* nutrient reference values, NRV

Further information You can find on carticol product information as well as on the manufacturer`s website : carticol.de

Study information
As a study participant, the study product will be sent to you free of charge and you agree to take 2 capsules per day for 16 weeks. In addition, you will answer a questionnaire on the internet in advance and then 4 times every 4 weeks. You can do it on your computer or smartphone.
There are three study groups that receive different formulations : either (1) carticol^® (the original formulation), or (2) placebo or (3) the pure undenatured type II collagen only.
You will be assigned randomly to one of the study groups, but neither you nor the manufacturer will know which group you belong to, i.e. this is a double-blind study.
If you fulfill all criteria and are ready to take 2 capsules over 16 weeks and answer the questionnaire every 4 weeks on the internet, you are eligible to participate in this study.
We will ask you a few questions on the next page, which you should answer. We will then ask for your address on the following page. After that you will get access to the questionnaire by an SMS on your mobile phone/smartphone.
At the end we will ask for your written consent to participate in the study.
Further information You can find on study participant information / consent form


3.1	Your first and last name
3.2	Year of birth [yyyy]
3.3	Gender	female male divers
3.4	your actual weight	kg
3.5	your height (body length)	cm
3.6	Your address (street + no.)
3.7	the ZIP and town
3.7	country
3.8	mobile number (to send you SMS)	[+49 176 123 4567]
3.9	e-mail address (to send you links or reminders)
The manufacturer is given your name and address to send you the study product. Neither the manufacturer nor other third parties will receive any other original personal data and we will only use them within the study and evaluate them statistically.
With a click on `send data` you will agree to take part in the study and we will get your data. Then we will send you an SMS and an e-mal with a link that you can use it in order to log into the study questionnaire on the internet for the first time. The link is just valid for 12 hours. All login data are filled in - all you need to do is click on LOGIN. After completing the questionnaire, we will ask you to print out your consent, sign it and send it to us. Only afterwards will a physician decide if you meet all inclusion / exclusion criteria. Thereafter you will receive a message from us as to whether we have passed your address on to the manufacturer.