Advice Pool - Health and Fitness

Researchers conducted a study on 51 diabetics to determine the effects of milk thistle,

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

and specifically an active constituent (flavolignans), on blood glucose levels.

The f

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

irst group of 25 patients received a 200 mg milk thistle (silymarin) tablet 3 times a d

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ay plus conventional therapy. The second group of 26 subjects received the same therap

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

y, but a placebo tablet instead of milk thistle. The patients were visited monthly and

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

glycosylated hemoglobin (HbA1c), fasting blood glucose (FSB), insulin, total cholestero

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

l, LDL and HDL, triglyceride, SGOT and SGPT levels were determined at the beginning and

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

the end of the study.

Results: There were significant decreases in HbA1c, FBS, total

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

cholesterol, LDL, triglyceride, SGOT and SGPT levels in milk thistle-treated patients c

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ompared with placebo as well as with values at the beginning of the study in each group

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

Researchers concluded that the silymarin treatment in type II diabetic patients for f

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

our months had a beneficial effect on improving the glycemic profile.

Preliminary stud

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ies in animals show that milk thistle may help protect the liver from injury by a varie

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ty of toxins ("poisons" such as drugs, viruses, alcohol, radiation, and poisonous mushr

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ooms) and limit the damage from them. To date, the most reliable milk thistle studies

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

n people show that milk thistle does not cure liver disease, but that milk thistle may

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

improve the way the liver works in patients with cirrhosis. Silymarin from milk thistl

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

e appears to promote the growth of some types of cells in the liver. Milk thistle may a

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

lso be an effective antioxidant, as reported by National Center for Complimentary and A

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

lternative Medicine in their monograph.

Source: Phytotherapy Research, October 30, 200

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.advicepool.org.ua/article/240324/advicepool-Milk-Thistle-Improves-Glycemic-Profile-in-Diabetics.html">Milk Thistle Improves Glycemic Profile in Diabetics</a>

BB link (for phorums):
[url=http://www.advicepool.org.ua/article/240324/advicepool-Milk-Thistle-Improves-Glycemic-Profile-in-Diabetics.html]Milk Thistle Improves Glycemic Profile in Diabetics[/url]

If you have a feeling that you are going down in debt, then there is a method to set aside money whilst paying off the loans. You can also set aside money in credit cards of high interest. A loan for debt consolidation can assist you in reducing the monthly reimbursements and saving money in rates of interest.

These days it seems every where you turn car dealers are trying to sell you on leasing a car instead of buying. While leasing may be good for some, for the majority of people it is not.

In Florida, the car insurance requirements are as follows- $10,000 for personal injury protection, also known as PIP, and $10,000 for property damage liability, also known as PDL.

Tags

Links

Advice Pool - Milk Thistle Improves Glycemic Profile in Diabetics

Related Articles: