Title of Invention	"A PROCESS FOR THE PREPARATION OF A HERBAL COMPOSITION FOR USE FOR THE TREATMENT FO RHEUMATOID ARTHRITIS"
Abstract	This invention relates to a process for A process for the preparation of a herbal composition for use for the treatment of rheumatoid arthritis comprising mixing :- i) 25 to 250 mg organic extract of Vitex nigundo (Nirgundi) plants ii) 25 to 250 mg organi extract of Pluchea lanceolata (Rasna) plants iii) 25 to 250 mg organic extract of Sida cordifolia (Bala) plants iv) 50-300 mg organic extract of Tinospora cordifolia (Guduchi) plants v) 50-300 mg organic extract of Commiphora mukul (Guggulu) plants vi) 50-30 mg organic extract of Withania somnifera (Ashwagandha) and/or the remainder being optionally a known conventional additives to every 500 mg of the said composition.

Title of Invention

"A PROCESS FOR THE PREPARATION OF A HERBAL COMPOSITION FOR USE FOR THE TREATMENT FO RHEUMATOID ARTHRITIS"

Abstract

This invention relates to a process for A process for the preparation of a herbal composition for use for the treatment of rheumatoid arthritis comprising mixing :- i) 25 to 250 mg organic extract of Vitex nigundo (Nirgundi) plants ii) 25 to 250 mg organi extract of Pluchea lanceolata (Rasna) plants iii) 25 to 250 mg organic extract of Sida cordifolia (Bala) plants iv) 50-300 mg organic extract of Tinospora cordifolia (Guduchi) plants v) 50-300 mg organic extract of Commiphora mukul (Guggulu) plants vi) 50-30 mg organic extract of Withania somnifera (Ashwagandha) and/or the remainder being optionally a known conventional additives to every 500 mg of the said composition.

Full Text	FIELD OF INVENTION This invention relates to a process for the preparation of a herbal composition for use for the treatment of rheumatoid arthritis and to a process for producing the same. The preparation of the present invention can advantageously be used for reduction of inflammation, relief of pain, restoration of functional capacity, body immunity and mental status among the patient suffering from rheumatoid arthritis. BACKGROUND OF INVENTION Rheumatoid arthritis is a common chronic inflammatory disease of joints with unknown cause. Though this disease involves the peripheral joints, but it is a systemic condition and may affect other organs of the body, it ranges from mild oligoarticular illness of brief duration with minimal joints damage to a relentless progressive polyarthritis with marked joint deformity. The females are affected approximately three times more than the males. Although the cause of Rheumatoid arthritis is unknown, however, its major cause is usually considered to be infection or autoimmune disorder. QBJECTS OF THE INVENTION An object of this invention is to propose an improved process for the preparation of a herbal composition for the treatment of rheumatoid arthritis. Another object of this invention is to propose, an improved process for the preparation of a herbal composition for the treatment of rheumatoid arthritis without any adverse effect. Still another object of this invention is to propose an improved herbal preparation for the treatment of rheumatoid arthritis which will also enhance the mental make up and general body immunity to overcome the infections. Further objects and advantages of this invention will be more clear from the ensuing description. At the outset of the description which follows, it is to be understood that the ensuing description only illustrates a particular form of this invention. However, such a particular form is only an exemplary embodiment, and without intending to imply any limitation on the scope of this invention. Accordinly, the description is to be understood as an exemplary embodiment and reading of the invention may not be intended to be taken restrictively. DETAILED DESCRIPTION OF THE INVENTION According to this invention there is provided a process for the preparation of a herbal composition for use for the treatment of rheumatoid arthritis comprising mixing :- i) 25 to 250 mg organic extract of Vitex nigundo (Nirgundi) plant, ii) 25 to 250 mg organic extract of Pluchea lanceolata (Rasna) plant, iii) 25 to 250 mg organic extract of Sida cordifolia (Bala) plant, iv) 50-300 mg organic extract of Tinospora cordifolia (Guduchi) plant, v) 50-300 mg organic extract of Commiphora mukul (Guggulu) plant, vi) 50-30 mg organic extract of Withania somnifera (Ashwagandha) plant and/or the remainder being optionally a known conventional additives to every 500 mg of the said composition. Viex negundo, commonly known as 'Nirgundi' belongs to Verbenaceae family. The dried leaves of this plant is extracted to collect a mixture of phenolic compounds containing flavonoids and resinous compounds. This mixture has shown analgesic, anti-inflammatory diuretic and anti-pyretic actions effective in the management of the joint pain. Further according to this invention there is provided a process for preparing a herbal preparation for the treatment of rheumatoid arthritis which comprises in admixing i 25 to 250 mg of Vitex negundo(Nirgundi) ii 25 to 250 mg of Pluchea lanceolata (Rasna) iii 25 to 250 mg of Sida cordifolia (Bala) iv 50-300 mg of Tinospora cordifolia (Guduchi) v 50-300 mg of Commiphora mukul (Guggulu) vi 50-30 mg of Withania somnifera (Ashwagandha), the remainder being optionally known additives to every 500 mg of preparation Preferably, the preparation comprises - V nigundo 50-125 mg P lanceolata 50-125 mg T cordifolia 95-150 mg S cordifolia 50-100 mg W somnifera 75-200 mg C mukul 50-300 mg the remainder being optionally known additives to every 500 mg of preparation Pluchea lanceolata also known as Rasna belongs to Compositae family. The dried leaves of this plant is extracted to obtain the mixture of active flavonic glycosides (like Quorcetin, Isorhamnetin etc.) and steroids. Studies have indicated this mixture as potent analgesic, antipyretic, anti-inflammatory, anti-arthritic, rejuvenative and vitalizing agents. Side cordifolia commonly known as Bala belongs to Malvaceae family. The root of this plant is extracted to get the mixture of alkaloid and steroids such as hypophorine, ephedrine, vascicine, vascicione, vascicinal and other sterol compounds. This mixture has demonstrated immuno modulating neutotropic, anti-inflammatory, diuretic and vitalizing actions in different studies. Tinospora cordifolia also known as Buduchi belongs to Menispermaceae family. The stem of the plant is extracted to collect the mixture of glycosides and alkaloid and contains essentially gloin and berberine compounds. Several studies have shown this mixture as immunomodulator, analgesic, neurotonic, cardiotonic and vitalizing agents. Commiphora mukul commonly known as Guggulu belongs to Burseraceae family. The oleogum resin of this plant is extrached to obtain the mixture of active terpenoids and sterols (as Gugulusterol I, II, III) and contains essentially °c -comphorene, cembrene, cambrene A, Mukulol and other terpenoidal compounds. This mixture has been identified as potent hypolipidaemic, anti-inflammatory, analgesic and anti-arthritic agents in different experimental and clinical studies. Withania somnifera also known as Ashwagandha belongs to Solanaceae family. The root of this plant is extracted to collect the mixture of free withanolides and glucowithanolides (Sitioindosides). Several studies have shown this mixture as anti-inflammatory, analgesic, anti-arthritic mood elevating, neurotonic, vitalizer and anti-stress agents. The organic extract of each of the above mentioned ingredient had been studied experimentally and clinically based on these observations, the present formulation containing the above ingredients have been tested. Example I The preparation containing organic extract of V. nigundo in the dose of 125 mg, and P. lanceolata in the dose of 25-250 mg, alongwith 1. Cordifolia in the dose of 25-250 mg. When administered in the diagnosed cases of rheumatoid arthristism exhbited marked reduction is inflammation and altered immunological profile of the patients. A significant reduction A-G ratio due to alleviation in Y -globulin indicates the role of T. Cordifolia as an immunomodulating agent. V. nigundo and P. lanceolata served as anti-inflammatory agents responsible for reduction in acute inflammatory process and pain magnitude of the patients. However, such a preparation did not provide any significant improvement in muscular contractility, functional capability of affected joint and does not restore the mental like depression characteristics of the patient. Example II In this series the drugs administered were the organic extracts of V. nigundo in the dose of 25-250 mg, P. lanceolata in the dose of 25-250 mg, and S. cordifolia in the dos of 50-500 mg. This formulation reduced the inflammation and also the muscle contractability. It provided relaxation in local joint muscles. However, only limited improvement could be observed in the present series of the study. Example III The preparation containing organic extract of V. nigundo in the dose 50 mg, P. lanceolata in the does of 70 mg, T. cordifolia in the dose of 100 mg., S. cordifolia in the dose of 80 mg., W. somnifera in the dose of 100 mg and C. mukul in the dose of 75 mg with the remainder being any known additive to constitute a capsule of 500 mg. Such a pill was administered into a patient and exhibited marked improvements in inflammation reduction, reduction in pain, decrease in the level of ESR, improvement in the grip holding time and walking ability, reduction in mental status and reduction in early fatigue. The herbal composition of the present invention is a novel composition produced due to the synergistic effects take place among the ingredients used for the preparation of the composition. I CLAIM: 1. A process for the preparation of a herbal composition for use for the treatment of rheumatoid arthritis comprising mixing :- i) 25 to 250 mg organic extract of Vitex nigundo (Nirgundi) plant, ii) 25 to 250 mg organic extract of Pluchea lanceolata (Rasna) plant, iii) 25 to 250 mg organic extract of Sida cordifolia (Bala) plant, iv) 50-300 mg organic extract of Tinospora cordifolia (Guduchi) plant, v) 50-300 mg organic extract of Commiphora mukul (Guggulu) plant, vi) 50-30 mg organic extract of Withania somnifera (Ashwagandha) plant and/or the remainder being optionally a known conventional additives to every 500 mg of the said composition. 2. A process as claimed in claim 1 wherein preferably i) 50-125 mg organic extract of V. nigundo ii) 50-125 mg organic extract of P. lanceolata iii) 95-150 mg organic extract of T. cordifolia iv) 50-100 mg organic extract of S. cordifolia v) 75-200 mg organic extract of W. somnifera vi) 50-300 mg extract of C. mukul are mixed with each other to obtain said composition. 3. A process as claimed in claim 1 wherein said organic extract of V. nigundo plant contain flavoroids and resinous compounds. 4 A process as claimed in claim 1 wherein said organic extract of P. lanceolata plant has a mixture of active flavonic glycosides (like Quorcetin, Isorhamnetin etc.) and steroids. 5. A process as claimed in claim 1 wherein said organic extract of S. cordifolia plant contain vascicinal and other sterol compounds. 6. A process as claimed in claim 1 wherein said organic extract of T. cordifolia plant has mixture of glycosides and alkaloid and contains essentially gloin and berberine compounds. 7. A process as claimed in claim 1 wherein said organic extract of C. mukul plant has a mixture of active terpenoids and sterols (as ' Guggulusterol I, II, III) and contains essentially -comphorene, cembrene, cambrene A, Mukulol and other terpenoidal compounds. 8. A process as claimed in claim 1 wherein said organic extract of W. somnifera plant contain a mixture of free withanolides and glucowithanolides(Sitioindosides). 9. A process for the preparation of a herbal composition for use for the treatment of rheumatoid arthritis substantially as herein described.

Full Text

FIELD OF INVENTION
This invention relates to a process for the preparation of a herbal composition for use for the treatment of rheumatoid arthritis and to a process for producing the same. The preparation of the present invention can advantageously be used for reduction of inflammation, relief of pain, restoration of functional capacity, body immunity and mental status among the patient suffering from rheumatoid arthritis.
BACKGROUND OF INVENTION
Rheumatoid arthritis is a common chronic inflammatory disease of joints with unknown cause. Though this disease involves the peripheral joints, but it is a systemic condition and may affect other organs of the body, it ranges from mild oligoarticular illness of brief duration with minimal joints damage to a relentless progressive polyarthritis with marked joint deformity. The females are affected approximately three times more than the males. Although the cause of Rheumatoid arthritis is unknown, however, its major cause is usually considered to be infection or autoimmune disorder.
QBJECTS OF THE INVENTION
An object of this invention is to propose an improved process for the preparation of a herbal composition for the treatment of rheumatoid arthritis.
Another object of this invention is to propose, an improved process for the preparation of a herbal composition for the treatment of rheumatoid arthritis without any adverse effect.
Still another object of this invention is to propose an improved herbal preparation for the treatment of rheumatoid arthritis which will also enhance the mental make up and general body immunity to overcome the infections.
Further objects and advantages of this invention will be more clear from the ensuing description.
At the outset of the description which follows, it is to be understood that the ensuing description only illustrates a particular form of this invention. However, such a particular form is only an exemplary embodiment, and without intending to imply any limitation on the scope of this invention. Accordinly, the description is to be understood as an exemplary embodiment and reading of the invention may not be intended to be taken restrictively.
DETAILED DESCRIPTION OF THE INVENTION
According to this invention there is provided a process for the preparation of a herbal composition for use for the treatment of rheumatoid arthritis comprising mixing :-
i) 25 to 250 mg organic extract of Vitex nigundo (Nirgundi) plant,
ii) 25 to 250 mg organic extract of Pluchea lanceolata (Rasna) plant, iii) 25 to 250 mg organic extract of Sida cordifolia (Bala) plant, iv) 50-300 mg organic extract of Tinospora cordifolia (Guduchi) plant, v) 50-300 mg organic extract of Commiphora mukul (Guggulu) plant, vi) 50-30 mg organic extract of Withania somnifera (Ashwagandha) plant and/or the remainder being optionally a known conventional additives to every 500 mg of the said composition.
Viex negundo, commonly known as 'Nirgundi' belongs to Verbenaceae family. The dried leaves of this plant is extracted to collect a mixture of phenolic compounds containing flavonoids and resinous compounds. This mixture has shown analgesic, anti-inflammatory diuretic and anti-pyretic actions effective in the management of the joint pain.
Further according to this invention there is provided a process for preparing a herbal preparation for the treatment of rheumatoid arthritis which comprises in admixing
i 25 to 250 mg of Vitex negundo(Nirgundi)
ii 25 to 250 mg of Pluchea lanceolata (Rasna)
iii 25 to 250 mg of Sida cordifolia (Bala)
iv 50-300 mg of Tinospora cordifolia (Guduchi)
v 50-300 mg of Commiphora mukul (Guggulu)
vi 50-30 mg of Withania somnifera (Ashwagandha),
the remainder being optionally known additives to every 500 mg of preparation
Preferably, the preparation comprises -
V nigundo 50-125 mg
P lanceolata 50-125 mg
T cordifolia 95-150 mg
S cordifolia 50-100 mg
W somnifera 75-200 mg
C mukul 50-300 mg
the remainder being optionally known additives to every 500 mg of preparation
Pluchea lanceolata also known as Rasna belongs to Compositae family. The dried leaves of this plant is extracted to obtain the mixture of active flavonic glycosides (like Quorcetin, Isorhamnetin etc.) and steroids. Studies have indicated this mixture as
potent analgesic, antipyretic, anti-inflammatory, anti-arthritic, rejuvenative and vitalizing agents.
Side cordifolia commonly known as Bala belongs to Malvaceae family. The root of this plant is extracted to get the mixture of alkaloid and steroids such as hypophorine, ephedrine, vascicine, vascicione, vascicinal and other sterol compounds. This mixture has demonstrated immuno modulating neutotropic, anti-inflammatory, diuretic and vitalizing actions in different studies.
Tinospora cordifolia also known as Buduchi belongs to Menispermaceae family. The stem of the plant is extracted to collect the mixture of glycosides and alkaloid and contains essentially gloin and berberine compounds. Several studies have shown this mixture as immunomodulator, analgesic, neurotonic, cardiotonic and vitalizing agents.
Commiphora mukul commonly known as Guggulu belongs to Burseraceae family. The oleogum resin of this plant is extrached to obtain the mixture of active terpenoids and sterols (as Gugulusterol I, II, III) and contains essentially °c -comphorene, cembrene, cambrene A, Mukulol and other terpenoidal compounds.
This mixture has been identified as potent hypolipidaemic, anti-inflammatory, analgesic and anti-arthritic agents in different experimental and clinical studies.
Withania somnifera also known as Ashwagandha belongs to Solanaceae family. The root of this plant is extracted to collect the mixture of free withanolides and glucowithanolides (Sitioindosides). Several studies have shown this mixture as anti-inflammatory, analgesic, anti-arthritic mood elevating, neurotonic, vitalizer and anti-stress agents.
The organic extract of each of the above mentioned ingredient had been studied experimentally and clinically based on these observations, the present formulation containing the above ingredients have been tested.
Example I
The preparation containing organic extract of V. nigundo in the dose of 125 mg,
and P. lanceolata in the dose of 25-250 mg, alongwith 1. Cordifolia in the dose of 25-250
mg. When administered in the diagnosed cases of rheumatoid arthristism exhbited
marked reduction is inflammation and altered immunological
profile of the patients. A significant reduction A-G ratio due to alleviation in Y -globulin indicates the role of T. Cordifolia as an immunomodulating agent. V. nigundo and P. lanceolata served as anti-inflammatory agents responsible for reduction in acute inflammatory process and pain magnitude of the patients. However, such a preparation did not provide any significant improvement in muscular contractility, functional capability of affected joint and does not restore the mental like depression characteristics of the patient.
Example II
In this series the drugs administered were the organic extracts of V. nigundo in the dose of 25-250 mg, P. lanceolata in the dose of 25-250 mg, and S. cordifolia in the dos of 50-500 mg. This formulation reduced the inflammation and also the muscle contractability. It provided relaxation in local joint muscles. However, only limited improvement could be observed in the present series of the study.
Example III
The preparation containing organic extract of V. nigundo in the dose 50 mg, P. lanceolata in the does of 70 mg, T. cordifolia in the dose of 100 mg., S.
cordifolia in the dose of 80 mg., W. somnifera in the dose of 100 mg and C. mukul in the dose of 75 mg with the remainder being any known additive to constitute a capsule of 500 mg. Such a pill was administered into a patient and exhibited marked improvements in inflammation reduction, reduction in pain, decrease in the level of ESR, improvement in the grip holding time and walking ability, reduction in mental status and reduction in early fatigue.
The herbal composition of the present invention is a novel composition produced due to the synergistic effects take place among the ingredients used for the preparation of the composition.

I CLAIM:
1. A process for the preparation of a herbal composition for use for the
treatment of rheumatoid arthritis comprising mixing :-
i) 25 to 250 mg organic extract of Vitex nigundo (Nirgundi) plant,
ii) 25 to 250 mg organic extract of Pluchea lanceolata (Rasna) plant, iii) 25 to 250 mg organic extract of Sida cordifolia (Bala) plant, iv) 50-300 mg organic extract of Tinospora cordifolia (Guduchi) plant, v) 50-300 mg organic extract of Commiphora mukul (Guggulu) plant, vi) 50-30 mg organic extract of Withania somnifera (Ashwagandha) plant and/or the remainder being optionally a known conventional additives to every 500 mg of the said composition.
2. A process as claimed in claim 1 wherein preferably
i) 50-125 mg organic extract of V. nigundo
ii) 50-125 mg organic extract of P. lanceolata
iii) 95-150 mg organic extract of T. cordifolia
iv) 50-100 mg organic extract of S. cordifolia
v) 75-200 mg organic extract of W. somnifera
vi) 50-300 mg extract of C. mukul are mixed with each other to obtain said composition.
3. A process as claimed in claim 1 wherein said organic extract of V. nigundo
plant contain flavoroids and resinous compounds.
4 A process as claimed in claim 1 wherein said organic extract of P. lanceolata
plant has a mixture of active flavonic glycosides (like Quorcetin, Isorhamnetin etc.) and steroids.
5. A process as claimed in claim 1 wherein said organic extract of S. cordifolia plant contain vascicinal and other sterol compounds.
6. A process as claimed in claim 1 wherein said organic extract of T. cordifolia plant has mixture of glycosides and alkaloid and contains essentially gloin and berberine compounds.
7. A process as claimed in claim 1 wherein said organic extract of C. mukul plant has a mixture of active terpenoids and sterols (as ' Guggulusterol I, II, III) and contains essentially -comphorene, cembrene, cambrene A, Mukulol and other terpenoidal compounds.
8. A process as claimed in claim 1 wherein said organic extract of W. somnifera plant contain a mixture of free withanolides and glucowithanolides(Sitioindosides).
9. A process for the preparation of a herbal composition for use for the treatment of rheumatoid arthritis substantially as herein described.

Documents:

619-del-1998-abstract.pdf

619-del-1998-claims.pdf

619-del-1998-complete specification (granted).pdf

619-del-1998-correspondence-others.pdf

619-del-1998-correspondence-po.pdf

619-del-1998-description (complete).pdf

619-del-1998-form-1.pdf

619-del-1998-form-2.pdf

619-del-1998-form-3.pdf

619-del-1998-form-5.pdf

619-del-1998-form-9.pdf

619-del-1998-gpa.pdf

619-del-1998-petition-others.pdf

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Patent Number

190439

Indian Patent Application Number

619/DEL/1998

PG Journal Number

30/2003

Publication Date

26-Jul-2003

Grant Date

15-Mar-2004

Date of Filing

11-Mar-1998

Name of Patentee

DINESH BOTHRA

Applicant Address

630, MARUTI MANE BLOCK, ASIAD VILLAGE COMPLEX, NEW DELHI-110049, INDIA.

Inventors:

#	Inventor's Name	Inventor's Address
1	GOVIND PRASAD DUBEY	BASIC PRINCIPLES, INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY, INDIA.
2	ARUNA AGRAWAL	BASIC PRINCIPLES, INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY, INDIA.

PCT International Classification Number

A61K 35/78

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA