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Rose-Hip Vitalwith Galactolipid (GOPO®) The future of Arthritis pain relief The future of Arthritis pain relief The future of Arthritis pain relief The future of Arthritis pain relief An overview

The Future of Arthritis Pain Relief

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Page 1: The Future of Arthritis Pain Relief

Rose-Hip Vital™with Galactolipid (GOPO®)

The future of Arthritis pain reliefThe future of Arthritis pain reliefThe future of Arthritis pain reliefThe future of Arthritis pain relief

An overview

Page 2: The Future of Arthritis Pain Relief

Rose-Hip Vital™

Keeping you jumping for joy!

Page 3: The Future of Arthritis Pain Relief

Rose-Hip VitalTM is a clinically documented

product, produced by Hyben Vital, Denmark,

marketed by Rose-Hip VitalTMAustralia (Pty) Ltd,

which may help alleviate some of the

symptoms related to osteoarthritis (OA) and

rheumatoid arthritis (RA).

Page 4: The Future of Arthritis Pain Relief

Rose-Hip Vital™ – The Story

• Prof Kaj Winther, MD. DMsci. and Prof Arsalan Kharazmi, University Hospital, Copenhagen, were contacted

• First in vitro studies - the results were impressive

• Rose-Hip VitalTM had anti-inflammatory effect

• Several clinical studies of Rose-Hip VitalTM on human beings

• Dansk Droge added pharmaceutical production

and marketing expertise to Rose-Hip VitalTM.

Page 5: The Future of Arthritis Pain Relief

Rosehip powder is the subject of numerous clinical trials, abstracts and research papers

including:

THETHETHETHE SCIENCE BEHIND ROSE-HIP VITAL™

Page 6: The Future of Arthritis Pain Relief

ABOUT ROSEABOUT ROSEABOUT ROSEABOUT ROSE----HIP VITALHIP VITALHIP VITALHIP VITAL™™™™ with with with with

GALACTOLIPID (GOPOGALACTOLIPID (GOPOGALACTOLIPID (GOPOGALACTOLIPID (GOPO®®®®))))

• Manufactured in Denmark by Hyben-Vital

• Sourced from 100% pure and natural rosehip – a natural anti-inflammatory

• Unique compound in Rose-Hip Vital™ is Galactolipid (GOPO®) (glycoside of mono and diglycerol) which is isolated from the active compound Rosa Canina L, which acts as a natural anti-inflammatory

• When dried at a certain temperature Galactolipid (GOPO®) is released, which helps to reduce inflammation by discouraging large numbers of white blood cells from accumulating in the joint

• Powerful antioxidant – Vitamin C absorbed more effectively than synthetic version

• Backed by over 30 clinical and scientific studies focussing on Osteoarthritis and Rheumatoid Arthritis

• Rose-Hip Vital™ is the only product available in Australia which tests for the patented

compound Galactolipid (GOPO®)

Page 7: The Future of Arthritis Pain Relief

GALACTOLIPID (GOPOGALACTOLIPID (GOPOGALACTOLIPID (GOPOGALACTOLIPID (GOPO®) ) ) ) –––– How it worksHow it worksHow it worksHow it works

• Some white blood cells in the body contain granules which enable them to

‘clean’ an inflamed Osteoarthritic joint by destroying the bacteria in it.

• Too many of these white blood cells can actually wear down the tissue

cartilage. In large numbers they can also produce chemical enzymes and

toxic free-radicals, which cause even more tissue damage.

• The accumulation of white blood cells combined with the release of

chemical substances causes pain and inflammation in the joint i.e.

Arthritis.

• The more inflamed the joint becomes, the more the white blood cells are

attracted to it, so the process is self-maintaining.

• The active compound Galactolipid (GOPO®®®®) works by discouraging large

numbers of white blood cells from accumulating in the joint, therefore

breaking the vicious cycle and alleviating and reducing joint damage.

Page 8: The Future of Arthritis Pain Relief

INGREDIENT PROFILE– Rose-Hip Vital™ with Galactolipid (GOPO®)

• 100% pure and natural rosehip

• Contains high level of active compound Galactolipid (GOPO®) using special

drying patented process

• Source of natural Vitamin C – absorbed more effectively than synthetic Vitamin C

• Free of yeast, gluten, wheat, dairy and lactose

• Contains no GM ingredients

• Non-allergen

• Does not contain shellfish

• Powder form suitable for vegetarians

• Shown to be well tolerated

• No gut irritation as found in common pharmaceutical drugs

Page 9: The Future of Arthritis Pain Relief

GCP STUDIES

• 94 patients with OA in knee/hip

• 112 patients with OA in various joints

• 100 patients with OA in knee/hip (Norwegian)

Page 10: The Future of Arthritis Pain Relief

DANISH STUDY

94 patients with Osteoarthritis in the hips or/and knees

by Kaj Winther, MD. DMsci

Department of Clinical Biochemistry, Copenhagen County Hospital Gentofte, Denmark

Published August 2005 in”Scandinavian Journal of Rheumatology”

Page 11: The Future of Arthritis Pain Relief

AIM

• To test if a herbal remedy made from the hips of a subtype Rosa canina (trade name Rose-Hip Vital™)

might reduce symptoms of osteoarthritis and consumption of rescue medication in patients suffering from osteoarthritis of the hip or knee.

• To test the tolerability of the product during a 3 month treatment period.

Page 12: The Future of Arthritis Pain Relief

REDUCTION IN WOMAC PAIN SCORE ON THE YES/NO BASIS IN

PATIENTS AFTER 3 WEEKS PLACEBO OR 3 WEEKS Rose-Hip VitalTM

% R

espo

nders

to t

reatm

ent

More than 8 out of 10 responded with a reduction in Pain

Score while on Rose-Hip Vital™. *P<0.0039 vs. placebo

Rose-Hip VitalTM

Placebo

82% 49%

P< 0.05 (statistical significance)

Page 13: The Future of Arthritis Pain Relief

PATIENTS EVALUATION OF DISEASE SEVERITY (PGAD) AFTER 3

MONTHS ROSE-HIP VITAL TREATMENT AND AFTER 3 MONTHS ON PLACEBO

A significant reduction in PGAD was observed during Rose-Hip VitalTM

treatment. *(p<0.001 within the Rose-Hip VitalTM group and p<0.031 vs. Placebo)

*

14.1 ±±±± 28.1 7.8 ±±±± 28.8

Delt

a

D

elt

aR

ed

ucti

on

In

cre

ase

Placebo

Pati

en

ts e

valu

ati

on

of

the d

iseas

e

Rose-Hip VitalTM

P< 0.05 (statistical significance)

Page 14: The Future of Arthritis Pain Relief

• 112 patients with Osteoarthritis in the various joints

• K. Winther, MD. DMsci, Department of Clinical Biochemistry, Copenhagen County Hospital Gentofte, DK

• A.Kharazmi, Professor, Department of Clinical Microbiology, University Hospital, Copenhagen, DK

E. Rein, Institute for Clinical Research

Published in July 2004 in

”Phytomedicine”

DANISH STUDY

Page 15: The Future of Arthritis Pain Relief

Flow chart

PLACEBO PLACEBOGroup B

Group A3 months 3 months

Rose-Hip VitalTM

+

Rose-Hip VitalTM

Page 16: The Future of Arthritis Pain Relief

This study showed the same

positive result when measuring pain and stiffness as the study on

94 patients with OA in hip/knee.

Page 17: The Future of Arthritis Pain Relief

NORWEGAN STUDY

• 100 patients with Osteoarthritis in the hips or/and knees

• by Odd Warholm, MD. Department of Orthopaedic

Surgery, Vestfold Central Hospital, Tonsberg, Norway

• Published, January 2003 in

• ”Current Therapeutic Research”

Page 18: The Future of Arthritis Pain Relief

Rose-Hip VitalTM

group

Placebo group

4 months treatment

4 months treatment

Method:

• 100 patients, all with an X-ray verified diagnosis of OA of the hip or knee, in a randomised, placebo- controlled, double-blind study. The Rose-Hip VitalTM group was given 5g of capsules daily for 4 months and the placebo group was given an identical amount of capsules.

• All patients were on a waiting list for either hip or knee surgery or on a list for final evaluation for surgery.

Page 19: The Future of Arthritis Pain Relief

% R

es

po

nd

ers

to

tre

atm

en

t

2 out of 3 responded with a reduction in Pain Score

while on Rose-Hip VitalTM. P<0.035 for Rose-Hip VitalTM vs. placebo

65% 44%

Rose-Hip VitalTM

Placebo

P< 0.05 (statistical significance)

JOINT PAIN RELIEF

Page 20: The Future of Arthritis Pain Relief

PASSIVE HIP JOINT MOVEMENTS

0

5

10

15

20

25

30

35

40

imp

rov

em

en

t %

Flexion External

rotation

Internal

rotation

Rose-Hip Vital TM

placebo

P = 0.003

P = 0.006

P < 0.001

P< 0.05 (statistical significance)

Page 21: The Future of Arthritis Pain Relief

Consumption of NSAID after 4 months of treatment

-20

-15

-10

-5

0

5

10

Procent %P < 0.016

Rose-Hip Vital TM

14,6%

8,3%

Placebo

Incre

ased

Decre

ased 8,3%

Page 22: The Future of Arthritis Pain Relief

Rose-Hip VitalTM Studies

• The GCP-studies show that Rose-Hip VitalTM reduces symptoms of OA due to:

• reduction of joint pain

• improvement of mobility in joints

• improvement in ADL (Active Daily Living)

• better mood and sleep quality

• reduction of consumption of NSAID - Paracetemol, Tramedoland Codein

• no side effects

Page 23: The Future of Arthritis Pain Relief

Osteoarthritis and Cartilage

Review:

Does the hip powder of Rosa canina (rosehip) reduce pain in osteoarthritispatients? - A meta-analysis of randomized controlled trials

•R. Christensen M.Sc.t, E. M. Bartels Ph.D., D.Sc.tt, R. D. Altman M.D.,

Professor, A. Astrup Ph.D., M.D., Professoril and H. Bliddal M.D., Ph.D.t*

•The Parker Institute, Musculoskeletal Statistics Unit, Frederiksberg Hospital,

Denmark Copenhagen University Library, Denmark

•David Geffen School of Medicine, University of California, Los Angeles, CA

90024, USA

•Department of Human Nutrition, Faculty of Life Sciences, University of

Copenhagen, Denmark

2008

Page 24: The Future of Arthritis Pain Relief

THE ACTIVE COMPOUND - GOPO®

• Anti-inflammatory agent

• Anti-oxidant agent

Galactolipid (2S)-1,2-di-O-[(9Z,12Z,15Z)-Octadeca-9,12,15-trienoyl]-3---ββββ-D-galactopyranosyl glycerol

O

CH2

CH

H2C

OH

OH

HO

CH2OH

O

1

O

O

O

CH3

CH3

O

• Anti-inflammatory agent

• Anti-oxidant agent

Galactolipid (2S)-1,2-di-O-[(9Z,12Z,15Z)-Octadeca-9,12,15-trienoyl]-3---ββββ-D-galactopyranosyl glycerol

Page 25: The Future of Arthritis Pain Relief

GOPO® is the registered name for the compound isolated from the rose-hip subtype Rosa canina used in Rose-Hip VitalTM

GOPO® is a glycoside of mono- and diglycerol (GMDG)

GOPO® was identified by using a bioassay-guided fractionation.

THE ACTIVE COMPOUND - GOPO®

Page 26: The Future of Arthritis Pain Relief

• Usage Patent

• GOPO®

• Manufacturing Process

INTERNATIONAL PATENTS

Page 27: The Future of Arthritis Pain Relief

“The Impact of Rosehip on Pain and Stiffness in Patients Suffering from

Rheumatoid Arthritis”

Multicentre study – University Hospital of Berlin &

University Hospital of Copenhagen

Page 28: The Future of Arthritis Pain Relief

STUDY DESIGN• Randomized controlled trial

• Double-blind

• Prospective 6 months treatment, 5 gr Rose-Hip Vital™ or placebo

• To investigate if a standardised powder (Rose-Hip VitalTM), made from husks and seeds of Rose-hip (Rosa canina), can reduce pain and stiffness in patients suffering from rheumatoid arthritis inaddition to usual care

STUDY AIM

Page 29: The Future of Arthritis Pain Relief

PARTICIPANTS:•Inclusion:

•Men and Women, > 18 years, with rheumatoid arthritis

•Diagnosis according to revised 1987 American Rheumatic Ass. Criteria

Exclusion:

• Lupus erythematosus

• Allergy to plant products

• Pregnancy

• Kidney or liver disease

• Drug abuse

• Psychiatric disease

Page 30: The Future of Arthritis Pain Relief

ENDPOINTS•Primary Outcome:

Difference 6 months to baseline

• HAQ

–Secondary Outcomes:

Difference 6 months to baseline

• DAS28

• Physician´́́́s Global Scale

• RAQoL and SF-12

• Pain medication

• Sore joints

Page 31: The Future of Arthritis Pain Relief

Results - Characteristics of Participants

Treatment group (N=44)

Placebo (N=45)

Age (years) (mean±SD) 57.1 ± 10.6 56.1 ± 12.0

Female sex (%) 86 93

Disease duration (years) (mean±SD) 12.7 ± 9.2 13.0 ± 9.9

BMI (kg/m2) (mean±SD) 25.7 ± 4.3 25.2 ± 4.6

Education > 10 years (%) 36 51

Full-time or part-time employment (%)

36 39

Living alone (%) 30 23

Smokers (%) 23 11

Page 32: The Future of Arthritis Pain Relief

-0.2

-0.15

-0.1

-0.05

0

0.05

0.1

0.15

0.2

0 3 6Months

HA

Q d

iffe

ren

ce

Active

Placebo

Results – HAQ Disease Index

p<0.032

Page 33: The Future of Arthritis Pain Relief

Results – HAQ Patient`s Global Scale

-10

-8

-6

-4

-2

0

2

4

0 3 6

Months

HA

Q d

iffe

ren

ce

Active

Placebo

p=0.078

Page 34: The Future of Arthritis Pain Relief

Results – Physician`s Global Scale

-20

-15

-10

-5

0

5

0 3 6

Months

Glo

ba

l s

ca

le d

iffe

ren

ce

Active

Placebo

p=0.012p=0.012

Page 35: The Future of Arthritis Pain Relief

RESULTS: QUALITY OF LIFE

• SF-12 physical significantly improved in favour of active treatment (p=0.013)

• RAQoL significantly improved as the result of active treatment (p=0.043)

• SF-12 mental score remained unchanged

• Pain medication was identical in the two groups and did not differ during the course of the study

• The number of sore joints declined by 45% (p<0.040) in pp patients as a result of active treatment.

Page 36: The Future of Arthritis Pain Relief

CONCLUSION

• Patients with RA benefited from additional treatment with standardized Rose-hip powder (Rose-Hip VitalTM)

• Per protocol analysis confirms these results

• Large, randomised trials are needed to confirm these promising results

Page 37: The Future of Arthritis Pain Relief

•The present data indicates that Rose-Hip VitalTM, a standardized Rose-hip

powder manufactured by Hyben Vital, Denmark, improves joint flexibility and

reduces pain in patients with OA and RA.

Page 38: The Future of Arthritis Pain Relief

TGA Approved Claims for Rose-Hip Vital™

Rose-Hip Vital™ may help:

• Temporarily relieve the pain of Arthritis, Osteoarthritis & Rheumatism

• Relieve inflammation and joint swelling

• Increase joint mobility

• Improve sleep when affected by joint discomfort

• Improve Osteoarthritis symptoms in the hands

• Improve the symptoms of lower back pain

POWDER

250

CAPSULES

Page 39: The Future of Arthritis Pain Relief

DOSAGE for Rose-Hip Vital™

POWDER

DOSAGE: 2.5g powder (1 tspn),

twice per day for three weeks

MAINTENANCE: 2.5g (1 tspn) once

a day

CAPSULES

DOSAGE: 5 Capsules (2.5g) twice a

day for three weeks

MAINTENANCE DOSAGE: 5 Capsules

(2.5g) once a day

Page 40: The Future of Arthritis Pain Relief

ARTHRITIS IN AUSTRALIAARTHRITIS IN AUSTRALIAARTHRITIS IN AUSTRALIAARTHRITIS IN AUSTRALIA• 3.8 million Australians suffer from OA; 400 000 suffer from RA.

• Australian Institute of Health & Welfare Report indicates 40% of sufferers use

Complimentary Therapies and Doctor referrals increasing.

• Consumers and Health Professionals looking for new innovations, with integrity,

backed by science, with demonstrated results.

• Trends indicate that there is significant support for Complimentary Therapies which

are backed by credible scientific studies.

Page 41: The Future of Arthritis Pain Relief

INFLAMMATION AT WORKINFLAMMATION AT WORKINFLAMMATION AT WORKINFLAMMATION AT WORK

Page 42: The Future of Arthritis Pain Relief

ABOUT ROSEABOUT ROSEABOUT ROSEABOUT ROSE----HIP VITALHIP VITALHIP VITALHIP VITAL™™™™ with with with with

GALACTOLIPID (GOPOGALACTOLIPID (GOPOGALACTOLIPID (GOPOGALACTOLIPID (GOPO®®®®))))

• Manufactured in Denmark by Hyben-Vital

• Sourced from 100% pure and natural rosehip

• Unique compound in Rose-Hip Vital™ is Galactolipid (GOPO®) (glycoside of mono and diglycerol) which is isolated from the active compound Rosa Canina L, which acts as a natural anti-inflammatory

• When dried at a certain temperature Galactolipid (GOPO®) is released, which helps to reduce inflammation by discouraging large numbers of white blood cells from accumulating in the joint

• Powerful antioxidant – Vitamin C absorbed more effectively than synthetic version due to high concentration

• Backed by over 30 clinical and scientific studies focussing on Osteoarthritis and Rheumatoid Arthritis

• Rose-Hip Vital™ is the only product available in Australia which tests for Galactolipid (GOPO®)

Page 43: The Future of Arthritis Pain Relief

GALACTOLIPID (GOPOGALACTOLIPID (GOPOGALACTOLIPID (GOPOGALACTOLIPID (GOPO®) ) ) ) –––– How it worksHow it worksHow it worksHow it works

• Some white blood cells in the body contain granules which enable them to

‘clean’ an inflamed Osteoarthritic joint by destroying the bacteria in it.

• Too many of these white blood cells can actually wear down the tissue

cartilage. In large numbers they can also produce chemical enzymes and

toxic free-radicals, which cause even more tissue damage.

• The accumulation of white blood cells combined with the release of

chemical substances causes pain and inflammation in the joint i.e.

Arthritis.

• The more inflamed the joint becomes, the more the white blood cells are

attracted to it, so the process is self-maintaining.

• The active compound Galactolipid (GOPO®®®®) works by discouraging large

numbers of white blood cells from accumulating in the joint, therefore

breaking the vicious cycle and alleviating and reducing joint damage.

Page 44: The Future of Arthritis Pain Relief

INGREDIENT PROFILE– Rose-Hip Vital™ with Galactolipid (GOPO®)

• 100% pure natural rosehip

• Contains high level of active compound Galactolipid (GOPO®)

using special patented process

• Source of natural Vitamin C – absorbed more effectively than

synthetic Vitamin C

• Free of yeast, gluten, wheat, dairy and lactose

• Contains no GM ingredients

• Does not contain shellfish

• Suitable and safe for most people

• No gut irritation as found in common pharmaceutical drugs

Page 45: The Future of Arthritis Pain Relief

RECENT MEDIA COVERAGEEveryone’s getting excited about Rose-Hip Vital™ with GOPO®

CHANNEL TEN NEWS MARCH 2010

Page 46: The Future of Arthritis Pain Relief

RECENT MEDIA COVERAGEEveryone’s getting excited about Rose-Hip Vital™ with GOPO®

Page 47: The Future of Arthritis Pain Relief

ADVISORY HOTLINE

1800 851 888www.rosehipvital.com.au

AUST L 91041

2010 © Rose-Hip Vital Australia Pty LtdIf symptoms persists consult your healthcare practitioner.

Always read the Label. Use only as directed.