TITLE:
A herbal nutraceutical formulation for chronic fatigue syndrome and method
of preparing the same.
FIELD OF THE INVENTION:
This invention relates to a herbal nutraceutical formulation for chronic fatigue
syndrome and a method of preparing the same.
BAGKGROUND OF THE INVENTION:
The term "Nutraceutical" was coined by combining the terms "Nutrition" and
"Pharmaceutical" in 1989 by Dr Stephen DeFelice, Chairman of the
Foundation for lnnovation in Medicine. "Nutraceutical" is any substance that
may be considered a food or part of a food and provides medical or health
benefits, encompassing prevention and treatment of diseases. Such
products may range from isolated nutrients, dietary supplements and diets to
genetically engineered "designer" foods, herbal products and processed
foods such as cereals, soups and beverages. "Nutraceuticals and functional
foods have received considerable interest because of their presumed
safety and potentia! nutritiona! and therapeutic effects". The nutraceutical
and functional food industry is in a unique position to capitalize on
consumers' interest. Be it a multinational pharmaceutical corporation, a
nutritional company, a large food multinational or a small vitamin selling firm,
all of them recognize the changing trends and are
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aware of the more health-seeking consumer trend. There is, thus, a
proliferation of these value-added products aimed at not only keeping
oneself healthy but also prevention/treatment of various ailments ranging
from heart diseases to cancer. The main aim is based on the disease
preventing phytonutrients present in herbal plants. Phenols, which are a
large group of phytonutrients, have great importance in preventive medicine.
Phytochemical is used to enhance the efficacy of vitamin C. lt can also act
against allergies, ulcers, tumors, platelet aggregation, controlling
hypertension and reduces the risk of estrogen induced cancer. The food
plays significant role in the general health of women. The right food has the
power to heal, keeping good health of body functions, ageing, rejuvenating,
immuno-modulating and prevention against diseases. A drug shows various
adverse effects that enables consumer to take food supplements to improve
health. Such products include isolated nutrients, dietary supplements, herbal
products and processed food such as cereals, soups and beverages.
Nutraceuticals are used in various diseases, Alzheimer's disease,
cardiovascular diseases, obesity disease, cancer etc.
Reference is made to Cleare A J, Okeane V, Miell J P (Levels of DHEA and
DHEAS and responses to CRH stimulation and hydrocortisone treatment in
chronic fatigue syndrome. Psychoneuroendocrinology, 2004: 724-732);
Forsyth L M, Preuss H G, MacDowell A L, Chtazze L Jr, Birkmayer G D,
Bellanti J A (Therapeutic effects of oral NADH on the symptoms of patients
with chronic fatigue syndrome. Ann Allergy Asthma lmmunol. 1999: 185-
191); HarlzA J, Bentler S, Noyes R, Hoehns J, Logemann C, Sinift S, Butani
Y, Wang W, Brake K, Ernst M and Kautzman H (Randomized controlled trial
of Siberian ginseng for chronic fatigue. Psychol Med. 2004.51-61); Jones M
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G, Goodwin C S, Amjad S and Chalmers R A (Ptasma and urinary carnitine
and acylcarnitines in chronic fatigue syndrome. CtinChimActa. (2005 , 17g-
177); Kuratsune H, Yamaguti K, Lindh G, Evengard B, Takahashi M, Machii
T, Matsumura K, Takaishi J, Kawata s, Langstrom B, Kanakura y, Kitani r
and Watanabe Y (Low levels of serum acylcarnitine in chronic fatigue
syndrome and chronic hepatitis type C, but not seen in other diseases. lnt J
Mol Med. 2.1 1998, 51-s6); Kuratsune H, yamaguti K, sawada M, Kodate s,
MadtiiT, lGnakura Y and lftani T. Dehydroepiandrosterone sutfate deficiency
in chronic fatigue syndrome. lnt J Mor Med. 1.1 1g9g, 143-146); Laviano A,
Meguid M M, Guijarro A, Muscaritoli M, cascino A, preziosa l, Molfino A,
Fanelli F R (Antimyopathic effects of carnitine and nicotine.
CurrOpinClinNutrMetab Care. 9.4 2006, 442449); Maes M, Mihaylova t,
DeRuyter M (Decreased dehydroepiandrosterone sulfate but normal insulinlike
grovuth factor in chronic fatigue syndrome (CFS): relevance for the
inflammatory response in CFS. Neuro Endocrinol Lett. 26.5 (2005): 4gT-
492);Plioplys A V, Plioplys S (Amantadine and L-carnitine treatment of
Chronic Fatigue Syndrome. Neuropsychobiotogy. 35.1 (19g7): 16-23); puri B
K (Long-chain polyunsaturated fatty acids and the pathophysiology of
myalgic encephalomyelitis (chronic fatigue syndrome). J ClinPathol. 2006
Aug 25); Puri B K, Holmes J, Hamilton G (Eicosapentaenoic acid-rich
essential fatty acid supplementation in chronic fatigue syndrome associated
with symptom remission and structural brain changes. lnt J ClinPract. S8.3
(2004): 297-299); D M, Broumand N, sahl L, Tifles J G (ln vitro effects of
echinacea and ginseng on natural killer and antibody-dependent celt
cytotoxicity in healthy subjects and chronic fatigue syndrome or acquired
immunodeficiency syndrome patients. lmmunopharmacology. 35.3 1997,
229-235); soetekouw P M, wevers R A, Vreken p, Erving L D, Janssen A J,
van der Veen Y, Bleijenberg G and van der Meer J W (Normal carnitine
levels in patients with chronic fatigue syndrome. Neth J Med. 57.1,2000,20-
24); Wanen G, McKendrick M, Peet M (The role of essential fatty acids in
chronic fatigue syndrome. A case-controlled study of red - cell membrane
essential fatty acids (EFA) and a placebo-controlled treatment study with high
dose of EFA. ActaNeurol Scand. 99.2 (1999): 112-11G); KARTA PURKH
SINGH KHALSA (C.D. N., A.H.G) Chunekar K C, Pandey G S
(GuduchyadiVarga BhavprakashNidhantu". Varanasi: ChaukhambhaBharati
Academy; 2006. p. 269); Tripathi R D (Astangasamgraha (sutrasthana)
Varanasi: Chaukhambha Sanskrit Pratisthan; 2006. pp. 142-315); Tripathi B
(CharakSamhita Part l. Varanasi: ChaukhambhaSurbharatiPrakashan; 2003.
pp, 454): Tripathi I (Raj Nighantu". Varanasi: ChaukhambhaKrishnadas
Academy; 2003. pp. 31); Tripathi I (Arkaprakash.TritiyaShatak". Varanasi:
ChaukhambhaKrishnadas Academy; 2006. pp. 45); Bhatta K R, Bhatta R K
and Swami L R (Siddha Bhaisajya Mani Mala: Vaishwanara Hindi
commentary.3rd ed. Varanasi: Chaukhambha Krishnadas Academy; 3. pp.
31); Pandit R P (MadanpalNighantu". Mumbai: Khemraj
SrikrishnadasPrakashan; 1998. p. 8); Kamat S D (DhanvantariNighantu".
Delhi: Chaukhambha Sanskrit Pratisthan; 2002. p. 1); Harishankar S L
(ShaligramVaishyakritShaligramNighantu. 3rd ed. Mumbai: KhemrajShri
Krishna Das Prakashan; 1912. pp. 251-3); Sharma A R (SushrutSamhita:
Sushrutvimarshini Hindi Commentary along with special Deliberation etc.
Part l. Varanasi: Chaukhambha Surbharati Prakashan; 2000. p. a19);
Sharma A R (SushrutSamhita. Sushrutvimarshini Hindi Commentary along
with special Deliberation etc. Part ll. Varanasi
ChaukhambhaSurbharatiPrakashan; 2001. pp. 311-317); Archna and
Namasivayam (1998 Antistressor effect of withania somnifera. Journa! of
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Ethnopharmacalogy, 1: 91-93); Auddy (2008 A Standardized Withania
Somnifera Extract Significantly Reduces Stress Releated Parameter in
Chronically Stressed Humans: A Double Blind, Randomized, Placebo
Controlled Study. JANA 1 1: 50-60); Mishra et al. Scientific Basis for the
Therapeutic use of Withania Somnifera: A Review. Alternative Medicine
Review, 2000, 5; 334-346); Barrows D M (Functional capacity evaluations of
persons with chronic fatigue immune dysfunction syndrome Am J
OccupTher. 1995 Apr;a9($:327-32); Dietert J M. (Possible role for early life
immune insult including developmental immunotoxicity in chronic fatigue
syndrome (CFS) or myalgic encephalomyelitis (ME) Toxicology. 2008 May
2;247(1):61-72); Anabalgan K, Sadique J. (Antiinflammatory activity of
Withaniasomnifera. lndian J Exp Biol1981;19: 245-249); Kupparanjan K, et
al. (Effect of ashwaganda( Withaniasomnifera Dunal) on the process of
aging in human volunteers. J Res Ayurueda Siddha.1980;1:247-258);
Wagner H, NOrr H, Winterhoff H (Plant adaptogens. Phytomed 1994; 1: 63-
67); Kuhn, Merrily A, and David Winston. Winston & Kuhn's Herbal Therapy
and Supplements: A Scientific and Traditional Approach.2 ed. Philadelphia:
Lippincott Williams & Wilkins, 2007);
Chronic fatigue syndrome is the condition of a person when there is
prolonged period of tiredness and fatigue that does not go away on taking
sufficient rest. This condition decreases the ability of a person to be engaged
in ordinary activities by more than half and is an immune dysfunction. A
typical approach in ayurveda, the traditional medicine of lndia, may be to
improve digestion and eliminate toxins with a detox program.
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OBJECTS OF THE INVENTION:
An object of this invention is to propose a herbal nutraceutical formulation for
chronic fatigue syndrome.
Another object of this invention is to propose a process for preparing a
herbal nutraceutica! formulation for chronic fatigue syndrome.
Still another object of this invention is to propose a combination of herbat
plants with a, base material.
BRIEF DESGRIPTION OF THE INVENTION:
This invention relates to a herbal nutraceutical formutation for chronic fatigue
syndrome comprising:
50 to 100 mg Tinosporacordifolia,
1 00-1 50 mg Sidacordifolia,
100-200 mg Withaniasomnifera, and
50-1 00 mg Ocimumtenuiflorum.
ln accordance with this invention there is atso provided a method of
preparing a herbal nutraceutical formulation comprising obtaining and
cleaning the fresh mature roots of Tinosporacordifotia;
subjecting the clean roots to the step of drying and purverizing,
treating the pulverized powder with cold water and collecting the filtrate,
subjecting the filtrate to the step of drying,
preparing acetic acid solution from the obtained filtrate,
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obtaining and cleaning stems and roots of Sidacordifolia,
subjecting the clean roots and stem to the step of drying and pulverizing,
extracting the fine powder with aqueous ethanol,
subjecting the extract to the step of vacuum drying,
obtaining and cleaning fresh mature roots of Tinosporacordifolia and
Ocimumtenuiflorum,
drying the clean roots at room temperature separately, and
subjecting the dried clean roots of each plant to the step of pulverizing,
mixing the extracts of each of them in the following ratio
Tinosporacordifolia - 50 to 100 mg
Sidacordifolia - 100 to 150 mg
Withaniasomnifera - 100 to 200 mg
Ocimumtenuiflorum - 50 to 100 mg
DETAILED DESCRIPTION OF THE INVENTION:
Contains the extract fractions of Tinospora cordifolia, Srda cordifolia, Withania
somnifera
Tinospora cordifolia: Dried stem parts/ roots
Tinsopora Cordifolia. The processes described below can be scaled up to
produce larger quantities of extracts. The details provided for preparation of
the following abstracts reflect the presently preferred method for extract
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preparations and not be consider as limiting. The quantities and times
described below can be varied substantially to provide suitable extracts of
Tinsopora Cordifolia in accordance with the invention.
The process extraction involves the following steps of: obtaining fresh mature
roots of Tinsopora Cordifolia and cleaning the obtained roots with one titer of
distilled water. The cleaning roots are air dried at room temperature for about
I - 10 hrs.
Extracting the fine powder obtained from pulverizing, with cold water and
collecting the filtrate in a glass beaker and air dried; preparing acetic acid
solution from the extract of Tinsopora Cordifolia .
Tinospora cordifolia (extract not less than 2 mg) contains glycosides,
sesquiterpenoids, steroids and alkaloids (Bitters) not less than 1.5o/o and atso
contain 11.2o/o protein and are rich in calcium and phosphorus with diterpenoid
lactones (tinosporaside should not be less than 0.03% to O.O4o/o) as
biochemical marker compound.
Sidacordifolia The processes described below can be scated up to produce
larger quantities of extracts. The details provided for preparation of the
following abstracts reflect the presently preferred method for extract
preparations and not be consider as limiting. The quantities and times
described below can be varied substantially to provide suitable extracts of
Sida Cordifolia in accordance with the invention.
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The process extraction involves the following steps of: obtaining fresh mature
stems and roots of Srda Cordifolia and cleaning the obtained roots / stems
with one liter of distilled water. The cleaning roots are air dried at room
temperature for about 10- 12 hrs and pulverized
Extracting the fine powder obtained from pulverizing, with aqueous ethanol
(6040%) and collecting the extract and vacuum dried. The extract of Sida
Cordifolia contains ephedrine, vasicinol, asicinonereducing sugar, alkaloids,
steroids and saponins total alkaloid content is 0.1 to 0.2 o/o.
Withaniasomnifera The process extraction involves the following steps of:
obtaining fresh mature roots of Tinsopora Cordifolia and cleaning the obtained
roots with one liter of distilled water. The cleaning roots are air dried at room
temperature for about 8 - 10 hrs. (extract not less than 500 mg) contains
alkaloids, withaferin A should not be less than 1.6% and withanine is the main
constituent and withanolides not less than 2.5% as biochemical marker
compound.
Ocimum tenuiflorum (Tulsi, extract not less than 200 mg) contains specific
aqueous methanolic (6040%) fraction of volatile oil, flavonoids (apigenin-6,8
and B - caryophylene (about 8%)), carbohydrates, phytosterols (campesterol,
stigmasterol, b-sitosterol), phenolics (gallic acid, procatechuic acid, ursolic
acid, engenol), tannins and fixed oils.
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Extracting the fine powder obtained from pulverizing, with water at a
temperature not exceeding 50 C for a time duration not exceeding 6 hrs,
cooling and collecting the filtrate.
(Tulsi, extract not less than 200 mg) contains specific aqueous methanolic
(6040%) fraction of volatile oil, flavonoids (apigenin-6,8 and B - caryophylene
(about 8%)), carbohydrates, phytosterols (campesterol, stigmasterol, bsitosterol),
phenolics (gallic acid, procatechuic acid, ursolic acid, engenol)
tannins and fixed oils.
All the extracts are mixed and dried in the following ratio:
Tinospora cordifolia - 50 to 100 mg
Srda cordifolia - 100 to 150 mg
Withania somnifera - 100 to 200 mg
Ocimum tenuiflorum - 50 to 100 mg
lndications:
Overcomes stress, lmproves tissue oxidation and nutrition, prevent
degenerative changes, modulates immune system, increases vitatity and
health

WE CLAIM:
1. A herbal nutraceutica! formulation for chronic fatigue syndrome
comprising:
50 to 100 mg Tinosporacordifolia,
1 00-1 50 mg Sidacordifolia,
100-200 mg Withaniasomnifera, and
50-1 00 mg Ocimumtenuiflorum.
2. A method of preparing a herbat nutraceutical formulation comprising
obtaining and cleaning the fresh mature roots of Tinosporacordifolia;
subjecting the clean roots to the step of drying and pulverizing,
treating the pulverized powder with cold water and collecting the filtrate,
subjecting the filtrate to the step of drying,
preparing acetic acid solution from the obtained filtrate,
obtaining and cleaning stems and roots of Sidacordifolia,
subjecting the clean roots and stem to the step of drying and pulverizing,
extracting the fine powder with aqueous ethanol,
subjecting the extract to the step of vacuum drying,
obtaining and cleaning fresh mature roots of Tinosporacordifolia and
Ocimumtenuiflorum,
drying the clean roots at room temperature separatety, and
subjecting the dried clean roots of each plant to the step of putverizing,
mixing the extracts of each of them in the following ratio
Tinosporacordifolia - 50 to 100 mg
Sidacordifolia - 100 to 150 mg
Withaniasomnifera - 100 to 200 mg
Ocimumtenuiflorum - 50 to 100 mg
3. The method as claimed in claim 1, wherein the clean roots of
Tinosporacordifolia is dried at room temperatures for 8-10 hrs.
4. The method as claimed in claim 2, wherein the roots and stem of
Sidacordifolia is dried at room temperature for 10-12 hrs.
5. The method as claimed in claim 2, wherein roots of Withaniasomnifera is
dried at room temperature for 8-10 hrs.