Title of Invention

"A HERBAL PREPARATION AND A PROCESS FOR THE PREVENTION OF LIVER CIRRHOSIS OF VARYING ETIOLOGY"

Abstract This invention relates to a herbal composition and a process for the preparation thereof wherein the herbal composition is useful for prevention and management of lever cirrhosis. The composition comprises a mixture of organic extracts of Aloe-vera (Ghritkumari), Phyllanthus urinaria (Bhui-amalki) and Andrographis paniculata (Kalmegh), with or without additive. The process comprises mixture of above herbs followed by optional additive or additives.
Full Text FIELD OF INVENTION
This invention relates to a herbal composition and a process for preparation thereof wherein the herbal composition is useful for prevention and management of liver cirrhosis of varying etiology. The composition of the present invention may also be advantageously used in other liver disorders like amebic hepatitis etc., and thus the further liver damage may be prevented.
BACKGROUND OF THE INVENTION
Cirrhosis is neither a single process nor a single disease, rather it is the end result of a variety of causes that produce chronic inflammatory change and liver cell injury with eventual distortion of the normal hepatic architecture. Chronic hepatitis and cirrhosis are the two main forms of chronic parenchymal liver disease. They are closely related because some forms of chronic hepatitis progress to cirrhosis.
A variety of cause of chronic parenchynal liver disease are mentioned such as alcohol, hepatitis B virus infection, chronic active hepatitis, immunological factors, metabolic disorders, drugs, cholestasis, prolonged hepatic congestion and malnutrition. Heptic cirrhosis can occur at any age though it manifests itself particularly in younger adults. In life it may be detected incidentally at surgery with minimal features such as hepatomegaly. Frequent complaints include weakness, fatigue, muscle cramps, weight loss and non-specific digestive symptoms such as anorxia, nausea, vomiting upper abdominal discomfort and gaseous abdominal distension. Portal hyperension, ascites, heptic encephalopathy, renal failure, infection, hepatocellular carcinoma are the complications of liver cirrhosis.
A variety of drug therapy is used for the management of liver cirrhosis but these agents itself have health hazards. Thus there is a need for a herbal formulation which is effective in the management of liver cirrhosis without any side effect.
OBJECT OF THE PRESENT INVENTION
An object of this invention is to propose a herbal composition and a process for preparation thereof useful for the prevention of liver cirrhosis among the individuals having one or more than one causative factors for developing liver cirrhosis.
Another object of this invention is to propose a herbal composition and process for preparation thereof useful for preventing the liver cirrhosis among the individuals who had suffered from hepatitis B virus infection in past.
Still another object of this invention is to propose a herbal composition and process for preparation thereof useful for preventing the liver cirrhosis among the individuals consuming alcohol.
Further object of the present inventions to propose a herbal composition and process for preparation thereof useful for the prevention of liver cirrhosis among the individuals treated by various chemotherapy for a chronic illness.
Still further object of this invention is to propose a herbal composition and process for preparation thereof useful for the prevention of further inflammatory changes and liver cell injury among the individuals suffering from liver cirrhosis.
t is to be understood that the composition of the present invention is not a mere admixture resulting in aggregation of properties but the different ingredients exhibit synergetic effect on each other as more of individual ingredient is effective for prevention and management of the liver cirrhosis
DESCRIPTION OF INVENTION
According to this invention there is provided a herbal preparation for the prevention of
liver cirrhosis of varying etiology comprising :
Organic extract of Aloe vera (Ghritkumari) 100-500 mg
Organic extract of Phyllanthus urinaria (Bhui-amalkai) 200-600 mg
Organic extract of Andrographis paniculata (Kalmegh) 200-600 mg
with or without known additives.
Further according to this invention there is provided a process for the preparation of a
herbal preparation for the prevention of liver cirrhosis comprising in admixing :
Organic extract of Aloe vera (Ghritkumari) 100-500 mg
Organic extract of Phyllanthus Urinaria (Bhui-amalkai) 200-600 mg
Organic extract of Andrographis paniculata (Kalmegh) 200-600 mg
with or without known additives.
The chemicals extracted out of the plant are used in the following dose range in a particular manner :
100-400 mg Aloe vera
200-600 mg Phyllanthus Urinaria
200-500 mg Andrographis paniculata.

The drugs administered with varying dose schedule and a careful monitoring of the clinical symptomatology present different results.
On the basis of oral administration of varying dose schedule, the most effective and preferred dose range comprised of:
Aloe vera (Ghritkumari) 200-350 mg
Phyllanthus Urinaria (Bhui-amalkai) 250-600 mg
Andrographis paniculata (Kalmegh) 250-500 mg
The remainder is optionally known additive to make the required preparation. Aloe vera:
This plant is commonly known as "Ghritkumari" belonging to family "Liliaceae" whose dried leaves are extracted to collect the mixture of pentosides barbaloin, isobarbaloin and etabarbaloin compounds. Various studies have suggested the purgative property of this mixture and further it is reported that the leaves is cathortic and refrigerant and useful in liver and spleen ailments. The plant contains the anti-inflammatory effects.
Phyllanthus urinaria:
This plant is commonly known as "Bhui-amalki" belonging to family "Enphorbiaceae" whose dried leaves and roots are extracted to collect the mixture of flavonoides (quercetin, astragalin, quercitrin, isoquercitrin, rutin) compound. Several studies have shown its hepatoprotective properties. This mixture is successfully used in jaundice, which acts as an appetizer.

Andrographis patiiculata:
This plant is commonly known as "Kalmegh" belonging to family "Acanthaceae" whose dried whole plant are extracted to collect the mixture of flavone and glycosides compound. Various studies on this plant has shown anti-inflammatory effects. This plant is useful in torpidity of liver.
The known additives are excipients such as calcium sulphate. Example I:
The preparation containing the organic extract of aloe-vera in the dose of 350 mg administered continuously for three months to the cases showing history of alcoholism, suffered from hepatitis B virus infection, immunological injury, metabolic disorders or taking treatment for some chronic illnesses exhibited mild improvement in the inflammatory changes of the liver observed in USG testing. Its purgative property was also noted.
Example 2:
The preparation containing the organic extract of Phyllanthus urinaria in the dose of 450 mg continuously for three months to the individuals suffered from jaundice or a disorder where liver'involvement is a known condition exhibited improvement in appeptite and general feeling of wellbeing. Improvement in general weakness was also noticed.
Examplc3:
The preparation containing the organic extract of Andrographis paniculata in the dose of 450 mg continuously for thr^e months to the cases suffered from liver disorders of varying etiology showed improvement in inflammatory changes, gastric distension including mild improvement in upper abdominal discomfort was also noticed.
Example 4:
The preparation containing the organic extract of Aloe-vera in the dose of 300 mg and the organic extract of phyllanthus urinaria in the dose of 400 continuously for three months to the cases showing some kind of liver involvement of varying etiology exhibited improvement in inflammatory changes and improvement in anorexia, including abdominal distension. A further loss of weight was checked and subjects reported feeling of well being and energetic than earlier.
Example 5:
The preparation containing the organic extract of Aloe-vera in the dose of 300 mg and organic extract of Andrographis paniculata in the dose of 350 continuously for three months to the cases showing evidence of some kind of liver involvement and suffered from various disease conditions exhibited improvement in various clinical symptomatology like muscle cramp, nausea and vomitting, abdominal discomfort and improvement in general weakness, and mild elevation in body weight.
Example 6:
The preparation containing the organic extract of Phyllanthus urinaria in the dose of 400 mg and Andrographis in the dose of 350 continuously for three months to the cases showing altered liver function tests showed regulation of the levels and marked improvement in clinical symptoms like appetite, body weight, abdominal discomfort, vomitting and nausea, disturbed sleep etc.
Example 7:
The preparation containing the organic extract of Aloe Vera in the dose of 250 mg. Phyllanthus urinaria in the dose of 350 mg and Andrographis paniculata in the dose of 350 mg continuously for three months to the cases showing positive clinical and laboratory finding of liver involvement suffered from various disease conditinos in the near past exhibited improvement in inflammatory changes in the and altered liver functions tests regulated to a great extent. Body weight also improved. The abdominal discomfort anoxia, vomitting improved and almost all the subjects reported improvement in their general health condition. Improvement in early fatigue and general weakness indicates the beneficial role of the test drug by regulating the disturbed liver function.
The present invention comprises a combination of organic extract of Aloe vera, Phyllanthus urinaria and Andrographis paniculata if given in an effective doses prevents the further liver damage of varying etiology. Aloe vera has effect on drug induced hepatotoxicity while Phyllanthus urinaria prevents the further liver damage from viral infections like hepatitis B. Andrographis paniculata if given along with the Aloe vera and Phyllanthus urinaria improves the liver functions in general. Single drug has specific role in preventing liver damage from drug induced toxicity but would not prevent from viral infections. Therefore, the combination of all the three drugs cover up all the causative factors and produce better results in the prevention and management of liver cirrhosis of varying etiology.
A combined drug formulation will provide 70-80% better effect/efficacy in the management of liver cirrhosis.
It is to be noted that the present invention is susceptible to modifications, changes and adaptations by those skilled in the art Such variant embodiments incorporating the concepts and features of the present invention, are intended to be within the scope of the present invention, which is further set forth under the following claims:-





WE CLAIM
1. A herbal preparation for the prevention of liver cirrhosis of varying etiology
comprising :
Organic extract of Aloe vera (Ghritkumari) 100-500 mg
Organic extract of Phyllanthus urinaria (Bhui-amalkai) 200-600 mg
Organic extract of Andrographis paniculata (Kalmegh) 200-600 mg
with or without known additives.
2. A preparation as claimed in claim I comprising:
Aloe vera (Ghritkumari) 200-350 mg
Phyllanthus Urinaria (Bhui-amalkai) 250-600 mg
Andrographis paniculata (Kalmegh) 250-500 mg
with known additives for a preparation of 300mg/500mg.
3. A preparation as claimed in claim I comprising the organic extract of Aloe vera
containing the mixture of pentosides barbaloin, isobarbaloin and beta barbaloin
compound.
4. A preparation as claimed in claim I wherein the organic extract of Phyllanthus
urinaria contains a mixture of tlavonoides.
5. A preparation as claimed in claim I wherein the organic extract of Andrograhis
paniculata contains a mixture of flavone and glycosides.
6. A process for the preparation of a herbal preparation for the prevention of liver
cirrhosis comprising in admixing :
Organic extract of Aloe vera (Ghritkumari) 100-500 mg
Organic extract of Phyllanthus Urinaria (Bhui-amalkai) 200-600 mg
Organic extract of Andrographis paniculata (Kalmegh) 200-600 mg
with or without known additives.
7. A process as claimed in claim 6 comprising:
Aloe vera (Ghritkumari) 200-350 mg
Phyllanthus Urinaria (Bhui-amalkai) 250-600 mg
Andrographis paniculata (Kalmegh) 250-500 mg
With or known additive for a preparation of 300 mg/500 mg.
8. A process as claimed in claim 6 comprising the organic extract of Aloe vera
containing mixture of pentosides, barbaloin, isobarbaloin and beta barbaloin
compounds.
9. A process as claimed in claim 6 comprising the organic extract of Phyllanthus
urinaria containing mixture of flavonoides.
10. A process as claimed in claim 6 comprising the organic extract of Andrographis
paniculata containing mixture of flavone and glycoside compounds.
11. A herbal composition as substantially described and illustrated herein.
12. A process for preparation of composition as substantially described and illustrated
herein.

Documents:

663-del-2002-abstract.pdf

663-del-2002-claims.pdf

663-del-2002-correspondence-others.pdf

663-del-2002-correspondence-po.pdf

663-del-2002-description (complete).pdf

663-del-2002-form-1.pdf

663-del-2002-form-18.pdf

663-del-2002-form-3.pdf

663-del-2002-form-4.pdf

663-del-2002-form-5.pdf

663-del-2002-gpa.pdf

663-del-2002-petition-others.pdf


Patent Number 220806
Indian Patent Application Number 663/DEL/2002
PG Journal Number 30/2008
Publication Date 25-Jul-2008
Grant Date 05-Jun-2008
Date of Filing 18-Jun-2002
Name of Patentee RAVI PATODIA.
Applicant Address
Inventors:
# Inventor's Name Inventor's Address
1 G.P. DUBEY
PCT International Classification Number A61K 37/78
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA