ARTHRITIS & JOINT PAIN

New Treatment Option: Supported by Natural

Synergy

Scientifically Developed * Clinically Tested

INFLAMMATION OF JOINTS

Nearly 1 in 2 people may develop

symptomatic knee OA by age 85 years &

Two in three people who are obese may

develop symptomatic knee OA in their

lifetime.

1 in 4 people may develop painful hip

arthritis in their lifetime.

Effects of glucosamine, chondroitin, or placebo in patients with

osteoarthritis of hip or knee: network meta-analysis: Year2010

Results: Compared with placebo, glucosamine, chondroitin, and their

combination do not reduce joint pain or have an impact on narrowing of joint

space.

Effect of glucosamine on pain-related disability in patients with chronic

low back pain and degenerative lumbar osteoarthritis: a randomized

controlled trial: Year 2010

Results: Among patients with chronic LBP and degenerative lumbar OA,

6-month treatment with oral glucosamine compared with placebo did not result

in reduced pain-related disability after the 6-month intervention and after 1-year

follow-up.

Arthritis & Rheumatology

Effect of Oral Glucosamine on Joint Structure

in Individuals With Chronic Knee Pain: A

Randomized, Placebo-Controlled Clinical

Trial

Volume 66, Issue 4, pages 930–939, April 2014

Conclusion

The results of this short-term study provide no evidence of structural benefits

(i.e., improvements in MRI morphologic features or urinary

CTX-II excretion) from glucosamine supplementation in individuals with chronic

knee pain.

Glucosamine & Chondroitin…Last 15 years

Phyto Chemistry

Phyto Research

Tulip Lab Proudly Introduces…

…A unique blend of Natural Scientific Synergy

In Patients with Osteo Arthritis

Flexicart offers:

59.85% reduction in mean joint pain score

assessed on VAS at end of Six months.

Statistically significant reduction in mean pain

score assessed on VAS at end of 30 days.

Complete Withdrawal of NSAIDs:

100% Patients stabilised on Flexicart monotherapy

at the end of 4 months therapy.

Increase in Joint Mobility :A significant reduction

(73.3%) in mean WOMAC stiffness score at the

end of 6 months.

Excellent Tolerability Profile.

At the end of 6 Months of treatment :

-50% of Subjects had good improvement

(75-95% remission of symptoms of OA).

-50% of Subjects had satisfactory improvement

(50-74% remission of symptoms of OA).

In Patients with Osteo Arthritis

Flexicart offers:

- Literature Review.

- Standardised Herbal Extracts.

- Acute Oral Toxicity Trial.

- Repeated dose toxicity study.

- International Clinical Trial Registration.

- Human Clinical Trial.

- Clinical Outcomes & Statistical Analysis.

- Publication in International Journals.

- Stability Studies & Validation of Commercial Batches.

* Scientifically Developed* Clinically Tested* Validated Internationally

The resinous part of Boswellia serrata possesses

monoterpenes, diterpenes, triterpenes, tetracyclic

triterpenic acids and four major pentacyclic triterpenic acids

i.e. β-boswellic acid, acetyl-β-boswellic acid, 11-keto-β-

boswellic acid and acetyl-11-keto-β-boswellic acid,

responsible for inhibition of pro-inflammatory enzymes.

Out of these four boswellic acids, acetyl-11-

keto-β-boswellic acid is the most potent

inhibitor of 5-lipoxygenase, an enzyme

responsible for inflammation.

Key Ingredients: Mechanism of Action

Boswellia serrata

Key Ingredients: Mechanism of Action

Inhibition of MAP kinases by Commiphora mukul

leads to down regulation of TNF-α, IL-1β and IL-2

- Inhibit platelet aggregation and

increase fibrinolysis.

- Possess antioxidant properties.

- Effects on high-sensitivity C-reactive

protein shows Anti-inflammatory

properties.

Commiphora mukul

Key Ingredients: Mechanism of Action Withania Somnifera has profound effects on

the hematopoietic system, acting as an

immunoregulator and a chemoprotective agent

- Increases production of inducible nitric

oxide synthase, an enzyme generated in

response to inflammatory mediators.

- Potent Antioxidant.

Withania Somnifera

Key Ingredients: Mechanism of Action

- Works against Denaturation of

protein.

- Potent Cox – 2 Inhibitor

Vitex negundo Reduces Inflammation and provides

analgesia by Suppressing Prostagalandin synthesis,

Anti histamine and membrane stabilizing effects.you

Vitex negundo

R. communis has flavonoids which depict

anti-inflammatory and anti-arthritic action from

R.Communis prevents GAG release from

osteoarthritic cartilage and also prevented

chondrocytes and cartilage surface degradation.

Proven chondroprotective effect

Ricinus communis

Key Ingredients: Mechanism of Action

Key Ingredients: Mechanism of Action

Nyctanthes arbortristis exhibits control of

Oedema, Reduction of Aspartate Aminotransferase

(SGOT),Reduction of Alanine Aminotransferase

(SGPT) and diminishing Quantity of Alkaline

Phosphatase (ALP)

Nyctanthes arbortristis

Reduction of Oedema & Free

Radical Scavenging effect

Key Ingredients: Mechanism of Action

- Analgesic and anti-inflammatory

- It also reduces the intake of rescue

medicine.

The anti-inflammatory

action of Zingiber officinale is due to

inhibition of COX-1, COX-2 and LOX(Lipoxygenase).

Zingiber officinale

Inclusion criteria:

Males and Females, age group 40-70 years .

Symptoms of osteoarthritis in one or both knee joints for a minimum of six

months and maximum for five years.

History of knee pain due to osteoarthritis requiring the use of NSAIDs,

Acetaminophen, or another analgesic agent on a regular basis ( > three days

per week) for at least six months before the screening visit.

OA confirmed by radiographs and diagnosed according to ACR diagnostic

Criteria for the osteoarthritis of the knee(s) .

Subjects may take tab Paracetamol for breakthrough pain.

Subjects not having knee joint deformity.

Subjects with pain VAS > 40 mm on weight bearing activities .

An Open Label, Prospective Clinical Study to Evaluate The Efficacy

and Safety of TLPL/AY/03/2008 in Patients suffering from

Osteoarthritis of the Knee(s)

An Open Label, Prospective Clinical Study to Evaluate The Efficacy

and Safety of TLPL/AY/03/2008 in Patients suffering from

Osteoarthritis of the Knee(s)

Changes in the mean knee joint pain assessed on visual

analogue scale ( VAS)

At the end of the treatment, the mean knee joint pain score reduced

significantly from baseline to 20.83+/-08.35 (59.85%)

Excellent Pain

control

Changes in the mean WOMAC combined score

At baseline visit, the mean WOMAC combined score

was 35.38 +/- 11.21, which was reduced significantly to

13.56 +/- 06.89 (61.67%) at end of the study.

Powerful Analgesic

effect

The mean WOMAC stiffness sub-scores reduced significantly

from baseline value 02.81 +/- 01.72 to 00.75 +/- 00.77 (73.3%)

at the end of the study.

Changes in the mean WOMAC Stiffness sub-score

Reduced Stiffness

enhances flexibility

Changes in the mean WOMAC difficulty sub-score

At baseline visit , the mean WOMAC difficulty sub-score

was 24.00 +/- 08.3, which was reduced significantly from baseline

value to 09.69 +/- 04.78 (59.6%) at the end of the study

Improved

Productivity

Changes in the mean time (seconds) taken to walk 50 feet

distance

At baseline visit, the mean time taken by the patients to walk

50 feet was 16.31 +/- 01.70 s.

The mean time to walk 50 feet was reduced significantly

from baseline value to 12.19 +/- 02.04 (25.26%) s at the end of

the study

Enhanced Mobility

Flexicart Assures:

• Complete withdrawal of NSAID with time dependent treatment regime.

• High Safety Profile.

• High level of patient compliance.

Histological Evaluation of RCLE (200mg/kg & 400

mg /kg)On CFA induced arthritic rats

Radiological analysis: Radiographic examination of CFA induced

hind paws of the arthritic rats on

day 28 did not revealed narrowing of the joint spaces, and subsequent

bone and cartilage destruction in

the knee joint in case of control group. Control group showed marked

soft tissue swelling due to

inflammation along with joint space narrowing (Fig 1). RCLE 400mg/kg

treated rats (Fig 3) showed

normal architecture of joint where as RCLE 200mg/kg treated rats

showed normal architecture of joint

with mild soft tissue swelling (Fig 2).

Radiographic Evaluation of RCLE (200mg/kg &

400 mg /kg)On CFA induced arthritic rats

Radiological analysis: Radiographic examination of CFA induced

hind paws of the arthritic rats on

day 28 did not revealed narrowing of the joint spaces, and subsequent

bone and cartilage destruction in

the knee joint in case of control group. Control group showed marked

soft tissue swelling due to

inflammation along with joint space narrowing (Fig 1). RCLE 400mg/kg

treated rats (Fig 3) showed

normal architecture of joint where as RCLE 200mg/kg treated rats

showed normal architecture of joint

with mild soft tissue swelling (Fig 2).

Conclusion: Ethanolic extract of Ricinus Communis leaf

possesses acute inflammatory and prophylactic

and therapeutic anti arthritic activity; these effects are dose

dependent. Anti-inflammatory and anti

arthritic effect might be speculated due to phytochemicals

present such as flavonoids and saponin.

Standardized Extract of Ricinus communis

is a Major component of FLEXICART

However additional long term studies will be needed to justify

Chondroprotective action and extent of such protection

of Flexicart with existing composition

Evidence cannot be Overruled !!!

Arthritis & Rheumatology

Effect of Oral Glucosamine on Joint Structure

in Individuals With Chronic Knee Pain: A

Randomized, Placebo-Controlled Clinical

Trial

Volume 66, Issue 4, pages 930–939, April 2014

Conclusion

The results of this short-term study provide no evidence of structural benefits

(i.e., improvements in MRI morphologic features or urinary

CTX-II excretion) from glucosamine supplementation in individuals with chronic

knee pain.

Can the evidence be Overruled ?

Enhanced MobilityImproved ProductivityReduced Stiffness

enhances flexibilityPowerful Analgesic

effect

Complete withdrawal of NSAID’s observed with regular

treatment regimen.

Excellent Tolerability Profile.

Excellent Safety Profile.

O R I G I N A L R E S E A R C H A R T I C L E

An open label, prospective, clinical study on a polyherbal formulation

in osteoarthritis of kneeSanjay U. Nipanikar, Manjit Saluja1, Vinod V. Kuber, Kalyan P. Kadbhane, Arvind Chopra1, Namdev R. Khade1

Department of Medical Services, R and D Center, Tulip Lab Pvt. Ltd., Ranjangaon, Shirur, Pune, 1Center for Rheumatic Diseases (CRD),

Hermes Elegance, Pune, India

For Business Queries & Product Details, Connect with:

VISHAL CHANDRA – General Manager, International Business. TULIP LAB PVT. LTD.

vishal@tlplindia.com Mobile/Viber +91-9167770803 Skype:vishalukraine

Tired from Glucosamine/ Chondroitin combinations ?

Flexicart is a new option for Arthritis management

* Scientifically Developed* Clinically Tested* Validated Internationally

For Business Queries & Product Details, Connect with:

VISHAL CHANDRA – General Manager, International Business.

E-mail:vishal@tlplindia.com Mobile/Viber +91-9167770803

Skype:vishalukraine TULIP LAB PVT. LTD.