JR.AS Vol. XXIV. No. 1-2. (2003)pp.1I-20

A PILOT STUDY ON THE EFFECT OF NARSINGHACHURNA IN THE MANAGEMENT OF AMAVATA

(RHEUMATOID ARTHRITIS)

A. K. Sharma I and Sunil Borkar-

(Received on 13-08-2002)

The study was conducted in 44clinically diagnosed cases of Amavata (RA)with an objective of clinical evaluation ofcompound drug formulation NarsinghaChurna ill the management of Amavata(RA) on the basis of various scientificparameters.

Statistically significant improvementwas observed in clinical. 'functional andhaematological parameters ill group A(treated with Narsingha Churna) and noimprovement was observed in theseparameters in group B (placebo group),patients after the course of the therapy.

Narsingh a Churna is an effectiveremedy in the management ofuncomplicated and new cases of Amavata(Rheumatoid arthritis)

Introduction

Amavata has striking similitude withdisease entity rheumatoid arthritis depictedin modem texts. Unequivocal role of Ama

in the pathogenesis and treatment of Amavatawas delineated by Acharyas and evidencedby successfully employing it in themanagement of Am avata. Aftercontemplative consideration of pathogenesis,it was decided to evaluate the efficacy ofcompound herbal formulation NarsinghaChurna [Chakradatta, Vrishyadhikara 1..5-24]in the management of disease Amavata (RA).

Riddle of causative factors ofRheumatoid Arthritis (RA) is yet mysteriousfor modern medical science. Upto muchextent success has been achieved in exploringthe consequential pathogenesis of RA, butdeficient results of treatment, established onthese fundaments, again but its viabilityunder the clouds.

On this glooming background of modemmedical science, Ayurveda is effectivelytreating the disease Amavata from theday's of yore, if patient approaches in early

I Prof and Head,2 M.D. (Ay.), final year scholar, P.O. Dept. of Kaya Chikitsa, National Institute of Ayurvcda, Jaipur

11

Ajay Kumar Sharma, et al.

stage or before the development of deformi-ties. To reverify ayurvedic fundamentals, it wasconsidered useful to evaluate certain ayurvedicdrugs which may be used as safe, effective,cheap and readily available remedies for thetreatment of this major disease. For this pur-pose a very popular preparation described inChakradatta namely Narsingha Churn a,(Vrishyadhikar, 15-24) was selected.

The Narsingha Churna is a compoundpreparation having 14 herbal drugs. Amongstthem Chitraka. Bhallataka, Trikatu and Tilaare best Agni Vardhaka, Ama Pachaka andmainly Kapha- Vatu Dosha Shamaka urugs.Shat avari, Gu du ch i, Var ahik an da andVidarik an da are well known for theirRasayana properties. Gokshura is well knownShothaghna and diuretic drug. Formulationlike Narsingha Churna with these pharmaco-dynamic properties is likely to break the chainof events occurring in the pathogenesis of dis-ease Amavala. Selected formulation appearsto be appropriate treatment for diseaseAmavata (RA)

It is expected that Narsingha Churna willcheck the formation of Ama Dosha at the levelof GIT by improving the status of Agni. On theother hand it is also expected to bring aboutcertain fundamental changes in the body of thepatient which will arrest the progress of the dis-ease Amavata (RA). With this backgroundNarsingha Churna was tried clinically in themanagement of a series of uncomplicated casesof Amavala on various scientific parameters.

Results obtained are very much encouraging.

Materials and Methods

44 cases suffering from AlIlavata (RA)were selected from OPDIJPD wings of Kava

Chikitsa Deptt. of Kayachikitsa, National In-stitute of Ayurveda, Jaipur on the basis of spe-cific proforma prepared according to signs andsymptoms of Amavata (RA) as described inMadhava Nidana and diagnosis was confirmedon the basis of recent criteria laid down byAmerican Rheumatism Association (1987).Selected patients were randomly divided in twogroups.

In Group A, 32 clinically diagnosed casesof Amavata (RA) were registered. Amongstthem 2 cases were dropped from trial due todevelopment of hyper sensitivity to compounddrug Narsingha Churna. In rest 30 cases ojAmavata, Narsingha Churna was administeredin the dose of 3 gm. B.D. with lukewarm waterfor 30 days along with local dry hot fomenta-tions to the affected joints.

In group B of 12 controlled subjects, glu-cose powder (in capsule packing) was admin-istered as a placebo in the dose of 5 gm B.D.with luke warm water for 30 days.

Restrictions regarding diet and other activi-ties were followed in both groups, as indicatedin ayurvedic texts. No other antibiotic or anti-inflammatory drug was given in either of thegroups during the study period.

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A PILOT STUDY ON THE EFFECT OF NARSINGHA CHURNA .

Formulation of Narsingha Churna (Chakradatta, Vrishyadhikar 15-24)

Drugs Pharmacologicalaction

RequiredQuantity(for 1 Kg.)

Bhallataka (Semecarpus anacardium line.f.) 110 gm Anti -inflammatory,Anti-oxidant

Satavari (Asparagus racemosus Willd.),Guduchi (Tinospora cordifolia Willd. Miers.),

Vidari (Pueraria tuberosa DC)Varahi Kanda (Dioscorea bulbi/era Line.)Chitraka (Plumbago zeylanica Line.)

Trikatu Shunthi, (Zingiber officinale Rose),Marica (Piper nigrum linn.),Pippali (Piper longum Linn.)

Tila (Sesamum orientale Linn.)

Gokshura (Tribulus terrestris Linn.)Madhu (Honey),Ghrita, (Claritied butter.)Sharkara (Sugar)

55 gm90gm

55gm70gm40gm

30gm

Immuno-modulation

Appetizer, hepatoprotective

Bio-availabilityenhancer action

55 gm Toxicity neutralizing actionOf Bhallataka), Anti-oxidantDiuretic, ShothaghnaSynergistic action, adjuvants

55 gm125 gm65 gm250 gm

Criteria of assessment: During the trial andfollow up study the patients were assessedon the following parameters:

Subjective improvement: Attempts weremade to elicit the subjective improvementsproduced by the drug under trial. Patientswere specifically asked about growing feel-ing of well being and improvement of jointfunctions after the therapy.

Clinical improvement: For this purposethe Symptom Rating Scale (Sharma, et. al)

was used to assess the relief in symptomslike morning stiffness, numbers of joints in-volved.joint pain, swelling in joints, restric-tion of movements, diffuse musculoskeletalpain, anorexia, thirst, malaise, fatigue, fe-ver and indigestion etc.

Functional assessment: Grip power, press-ing power, walking time and functional in-dex were used for the assessment of func-tional status and to assess the pattern of clini-cal recovery.

13

Ajay Kumar Sharma. et at.

Haematological and biochemicalstudies: Hb gm%, ESR, TLC, OLe. C-reactive protem, RA factor and serum uricacid levels were recorded before and afterthe therapy in registered cases to evaluatethe nature and extent of changes in relationto course of the disease Amavata (RA).

Observations and Results

There was a growing feeling of well beingafter the course of therapy in the patientstreated with Narsingha Churna. No suchchange in the feeling of well being afterthe therapy was reported by any patient ofplacebo treated group. Other observationsare summarized below:

Clinical improvement: Table I shows thatthe observations obtained in group A(treated with Narsingha Churna) werehighly significant regarding the clinicalrecovery. Statistical analysis of the datashowed highly significant improvement inall symptoms except thirst and fever.

It's clear from table 2 that no improvementwas observed in placebo treated group B.

Functional improvement: Variousobservations summarized in table 3 & 4indicate highly significant improvement infunctional parameters in group A whereasno improvement was observed in group B.

In group A, highly significantImprovement in grip power of right andleft hand was observed. Similarly highly

significant improvement in pressing powerof both the hands was observed. There wasa trend of decrease in walking time whichis statistically highly significant. Highlysignificant improvement was noticed infunctional index of patients after thetherapy.

In group B, no significant changes wereobserved in initial and final mean score offunctional parameters after the therapy.

Haematological changes: Table No.5 &6 show statistically significant reduction inthe level of ESR and TLC in group A withminimal elevation in the level ofHb gm%,which was statistically insignificant.whereas statistically insignificant changeswere observed in all haematologicalparameters of group B.

Biochemical changes: No changes wereobserved in serological investigationsbefore and after the therapy in both thegroups.

Overall effect of therapy: Table 7indicates the comparative overallpercentage of improvement in both thegroups on the basis of three parameters vizi) Clinical improvement, ii.) Functionalimprovement and iii.) Haematologicalchanges. It was statistically significant ingroup A (treated with Narsingha Churna),whereas insignificant in group B (placebogroup).

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A PILOT STUDY ON THE EFFECT OF NARSfNGffA ('f!URNA ......

Table 1Clinical recovery in 30 patients of Amavata (RA) treated with Narsingha

Churna

Observation Mean S.D. S.E. "t' "p'

B.T. A.T. Diff. + ± value value

Morning stiffness 1.90 0.77 1.13 0.82 0.15 7.58 <.001No. of joints involved 8.93 6.80 2.13 2.29 0.42 5.11 <.001Joint pain 3.07 1.03 2.03 0.81 0.15 13.77 <.001Swelling on joints 2.83 1.03 1.80 0.81 0.15 12.24 <.001Restriction of movement 1.96 0.85 1.12 0.71 0.14 7.99 <.001Diffuse musculoskeletal pain 2.57 0.57 2.00 0.79 0.14 13.90 <.001Anorexia 2.00 0.21 1.79 0.72 0.15 12.17 <.001Thirst 1.25 0.25 1.00 0.82 0.41 2.45 <.05Malaise 2.38 0.46 1.92 0.69 0.13 14.25 <.001Fatigue 2.14 0.46 1.68 0.61 0.12 14.52 <.001Fever 1.00 0.00 1.00 0 0 0 >.05Indigestion 1.70 0.10 1.60 0.70 0.22 7.24 <.001

B.T. - Before Treatment, A.T. - After Treatment, Diff. - difference

Table 2Clinical recovery in 12 patients of Amavata (RA) of placebo group

Observation Mean S.D. S.E. 't' 'p'

B.T. A.T. nur, + + value value

Morning stiffness 2.17 2.17 0 0 0 0 <.05No. of joints involved 8.67 8.67 0 0 0 0 <.05Joint pain 3.08 3.00 0.08 0.29 0.08 1 <.05Swelling on joints 2.92 2.92 0 0 0 0 <.05Restriction of movement 1.33 1.33 0 0 0 0 <.05Diffuse musculoskeletal pain 2.25 2.17 0.08 0.29 0.08 1 <.05Anorexia 1.55 1.55 0 0 0 0 <.05Thirst 1.00 1.00 0 0 0 0 <.05Malaise 1.91 1.91 0 0 0 0 <.05Fatigue 2.00 2.00 0 0 0 0 <.05Fever 0 0 0 0 0 0 0Indigestion 0 0 0 0 0 0 0

B.T. - Before treatment, A.T. - After treatment, Diff. - Difference

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Ajay Kumar Sharma. et al.Table 3

Functional changes in 30 patients of Amavata (RA) treated with NarsinghaCIItI ru a

Observation Mean S.D. S.E. ' t' 'p'

RT. AT. Dill. + + value value

Grip power in mmHg RT 234.37 246.20 11.83 16.11 2.94 4.02 <.001LT 222.2 233.0 10.80 16.56 3.02 3.57 < ..01

Pressing power in mm Hg RT 89.53 101.73 12.20 13.40 2.45 4.99 <.001LT 73.54 83.93 10.40 13.31 2.43 4.28 <.001

Walking time in seconds 122.07 115.0 7.07 4.23 0.77 9.lb <.001Functional index 1.63 1.22 0.40 0.50 0.09 4.40 <.001

B. T. - Before Treatment, A. T. - After Treatment, Diff. - Difference

Table 4Functional changes in 12 patients of Amavata (RA) of placebo group

Observation Mean S.D. S.E. 'f' 'p,

B.T. AT. Diff. + + value value

Grip Power in mmHg RT 235.00 235.83 0.83 2.89 0.83 1.00 >.05LT 220.83 222.5 1.67 3.89 1.12 1.48 >.05

Pressing power in mm Hg RT 106.67 109.17 2.5 4.52 1.31 1.91 >.05LT 95.0 98.33 3.33 1.78 2.25 148.00 >.05

Walking time in seconds 119.08 117.42 1.67 3.96 1.14 1.46 >.05Functional index 1.25 1.25 0 0 0 0 ".0.:'

B.T. - Before Treatment, AT. - After Treatment, Dill. - Difference

Table 5

Haematological changes in 30 patients of Amavata (RA) treated withNarsingha Churna

Observation Mean S.D. S.E. -r 'p

B.T. AT. DiU. + + value value

Haemoglobin in gm % 11.91 12.08 0.17 0.86 0.16 1.11 >.05ESR in mm/ hr. 31.30 23.77 7.53 11.30 2.06 3.65 <.01Total leucocyte count 7716.63 6923.57 793.17 1862.67 340.08 2.33 <.05

BT. - Before Treatment, AT. - After Treatment, Diff. - Difference

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.\ PILOT STUDY ON THE EFFECT OF NARSINGIIA ClIlIRNA .

Table 6

Haematological changes in 12 patients of Amavata (RA) of placebo group

Observation Mean S.D. S.E. 't' 'p'B.T. A.T. Diff. + + value value

IIaemoglobin in gm % 11.61 11.53 0.08 0.64 0.18 0.45 >.05E.S.R. in 111111/ hr. 38.67 33.0 5.67 9.70 2.80 2.02 >.05Total leucocyte count 9741.67 8875.00 866.67 1918.49 553.82 1.59 >.05

B.T. - Before Treatment, A.T. - After Treatment. Diff. - Difference

Table 7Comparative percentage of improvement in different groups of Amavata

(R.A) on the basis of various parameters

Assessment of parameters

ESR in rum/hr.

Group

Treatment Placebo

% 56.61 0.97t 6.32 1.96P <.001 >.05

Highly significant Insignificant

'Yo 6.68 0.86t 4.79 1.51P <.01 <.05

Significant Insignificant

% 1.42 0.72t 1.11 0.45P <.05 >.05

Insignificant Insignificant

'Yo 10.28 8.89t 2.33 1.59P <.05 >.05

Significant Insigni ficant

% 24.05 14.66t 3.65 2.02p <.01 >.05

Significant Insignificant

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Clinical improvement

Functional improvement

Haematological changeHbgm%

TLClcu.mm

Ajay Kumar Sharma, ct at.

Discussion

It is practically impossible to treatchronic and complicated cases of Amavatawith single drug or simple preparations usedin Samshmnana therapy. Multifactorialapproaches are needed to check theaetiopathogcnesis of disease Amavat a.Considering all these factors it was decidedto launch a clinical trial of NarsinghaCliurna in the management of a series ofuncomplicated patients of Amavata.

The clinical evaluation of NarsinghaChurna indicated a significant symptomaticrelief in patients of Amavata (RA) after thecourse of therapy. A significant reductionin the severity of pain, swelling, tenderness,morning stiffness, restriction of movement,fatigue and anorexia was recorded. Noimprovement in symptoms was observed inplacebo treated group. There wasstatistically significant improvement in grippower, pressing power, walking time andfunctional index in patients treated withNarsinglia Churna. suggesting tremendousimprovement injoint functions of upper andlower extremities. On the contrary nochange were observed in placebo treatedgroup on these parameters. Besides clinicaland functional recovery the present seriesof patients treated with Narsinglia Cliurnashowed significant improvement Inhaematological parameters,

It is felt that the beneficial effects ofNarsingha Ch urn a therapy in themanagement of A mavata (RA) as observedin present series of patients may not be

simply due to anti-inflammatory andanalgesic activities of this preparation. Thecomponent drugs of Narsingha Churnamight be producing more fundamentalchanges in the system which might beresponsible for effects of therapy and otherrestoratives effects.

It is of an utmost importance tounderstand that Bhallataka (Semecarpusana cardium] is one of the importantingredients of Narsingha Churna, whichpossess anti- inflammatory, anti- oxidantand Ra sava n a properties. Shat avari,Guduclii, Bhullataka. Vidari and VarahiKalida have potent immunomodulaungeffects. Since Am ava t a is a chronicdebilitating disease, so administration ofsuch drugs is of great help to the patient. Itis worth mentioning here th~t Trikatu haspotent bio-availabi lity enhancer activity.Thus Trikatu acts as a catalyst in inducinganti-inflammatory and immunomodulatingeffect of other components of NarsinghaCliurna. Basically Goksliura is a potentdiuretic agent which acts as specificSh ot h aglin a agent. To the compoundNarsinglta Churna, Tila, Glirita, Sharkara.Madhu and Chitraka are also added whichact synergistically. Tila specificallyneutralizes the toxic effects of Bhallataka.

Therefore the compound drugNarsingha Cliurna is a classical agent andis a good remedy for the management ofAm avat a (RA). Two patients reportedhypersensitivity to Narsinglia ('/I/II"I/a. Theyreported itching allover the body, probably

18

A PILOT STUDY ON THE EFFECT OF NARSINGHA CHURNA .

due to Bhallataka, which was controlled whenthe drug was withdrawn.

Conclusion

It can be concluded that Amavata (RA) isa systemic disease with remarkable psychosomatic background associated with gastrointestinal dysfunction.

Narsingha Churna is a good remedy for the

management of Amavata (RA) as it not only

produces symptomatic relief and anti-

inflammatory effects on inflammed joints but

also influences the level of Agni and breaks the

chain of events in the production of Ama Dosha

and Amavala.

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Choudhari, R,D. 1996

Gupta, A. and Sharma AX. 1999

Harrison 1998

Langenegger, T. Vitz,E. Fransen, J. and Tucki, G.S.

2000

Pandey, V.N. and Malhotra, S.c. 1990

Sharma, AK. 1979

Singh, R.H. and Madikonda, P. 2001

Tripathi, I 1997

Charaka Samhita, Chowkhambha BharatiAcademy, Varanasi

Herbal Drug IndUSl1Y.

The efficacy ofVasti in Rheumatoid Arthritis(Amavata), N.LA. Jaipur.

Harrison 's Principal oflnternal MedicineMcGraw-Hill New York.

Clinical Quality Management in RA:Putting, Theory into practice, RheumatologyVol. 39, P 542-549.

Phyto-Chemical Investigations of CertainMedicinal Plants Used ill AyurvedaC.C.R.A.S., New Delhi.

Clinical and Biological studies on the role ofAmrit Bhallataka as a Naimittika Rasayanain R.A (Amavata), Faculty of Ayurveda.LM.S., B.H.U., Varanasi.

New Dimensions of the concept of A ma,Ayurmedline, Bangalore.

Chakradatta, Chowkhambha SanskritSansthan, Varanasi.

19

Ajay Kumar Sharma, ct at.

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