J.R.A.S. Vol. XXXI, No.2, April-June." 10pp. 15-24

CLINICAL EFFICACY OF SUNTHI GUGGULUGODANTI BHASMA IN THE MANAGEMENTOF AMAVATA (RHEUMATOID ARTHRITIS)

H. M. L. Meena, B. R. Meena, M. M. Sharma' and G.Babu4

(Received on 30-07-2008)

Abstract

A single blind clinical study was conducted at CR1 (Ay), Jaipur; in order toevaluate the efficacy of the combination of Sunthi, Cuggulu, Godanti, in theManagement ofAmavata (Rheumatoid Arthritis), during the period 2004 and 2005. Atotal 47 well established cases ofAmavata were selected for the study, as per theprotocol designed by CCRAS, New Delhi and the criteria of selection of the patientswas based on 1987 Revised criteria of American College of Rheumatology (ARA 1987),for the classification, diagnosis ofRheumatoid Arthritis. The drug Sunthi, Cuggulu andGodanti Bhasma (1 :2: 1 ratio) 2 gms thrice a day with warm water was administered tothepatients. The improvement of subjective and objective parameters was assessed andhighly significant improvement was observed after six weeks of treatment. Out of 4 7cases studied, 15 (31.91 %) cases got good response, 15 (31.91 %) gotfair response, 8(/7.02%) got poor response and 03 (6.39%) cases did not get any response, while 06(/2.77%) cases were dropped out from the study After the overall assessment, it hasbeen observed that the drug combination of Sunthi + Guggulu + Godanti is highlyeffective in the management of Amavata (Rheumatoid Arthritis) and no adverse effectswere observed.

Introduction

Amavaia (Rheumatoid Arthritis), asystemic disease mainly affecting thejoints has still remained a problem ofmedical science. It is considered acrippling disease for its painful featuresand destructive progress leading todisability and deformity. Madhavakara

(900 AD) has identified first time thedisease Amavata as separate entity anddescribed the disease in detail. On theother hand, description of Amavata is notfound in the ancient Ayurvedic classics asa separate entity.

In Charak Samhita (1000 B.C.) therelation of "Ama" with localized paindigestive disorders are described.

1&2. Research Officer (Ay.), Central Research Institute, Jaipur; 3. ResearchOfficer (Ay.), CCRAS, New Delhi and 4.Research Officer- In- Charge, Central ResearchInstitute (Ay.), Jaipur.

15

H. M. L. Meena et at.

Chakrapani was mentioned aboutAmavata in his commentary on CharakaSamhita. In Susruta Samhita the relationof "Ama" with localized pain has beendescribed. Vagbhata opined the disease inwhich Ama is involved should be termedas Sarna.

It is a polyarticular joint diseasedescribed in ancient Indian system ofmedicine has high resemblance withRheumatoid Arthritis of the modemmedicine. It is an auto immune diseasethat causes chronic inflammation of thejoints; it can also cause inflammation ofthe tissue around the joints as well as otherorgans in the body. While RheumatoidArthritis is a chronic illness, meaning itcan last for years, patients may experiencelong periods without symptoms.Typically, however, Rheumatoid Arthritisis a progressive illness that has thepotential to cause joint destruction andfunctional disability. There is no knowncure for Rheumatoid Arthritis. To date thegoal of treatment in Rheumatoid Arthritisis to reduce joint inflammation and pain,maximizes joint function and preventsjoint destruction and deformity, There aredisadvantages in the presently availablepotent synthetic drugs because of theirtoxicity and re-appearance of symptomsafter discontinuation. Therefore, thesearch for screening and development ofdrugs for their anti-inflammatoryactivities is unending problem and there ismuch scope of finding anti-rheumaticdrugs from indigenous plants.

In the last one and a half decade,various drugs have been studied by theC.C.R.A.S. for the management ofAmavata. Among them Guggulu

preparation in different formulations havebeen found quite effective in themanagement of Amavata. Keeping this inview, the present study has been plannedwith Sunthi, Guggulu, Godanthi (I :2: 1ratio) for its management.

A clinical study was conducted on47 patients, suffering from RheumatoidArthritis on OPD & IPD level, at CentralResearch Institute of Ayurveda, Jaipur.The criteria of selection of patients werebased on signs and symptoms andLaboratory investigations as mentioned inthe classical texts.

Material and Methods

A total number of 47 well-established cases of Amavata wereregistered for this clinical study, duringthe period of 2004 and 2005, from CRI(Ay), Hospital, Jaipur.

Drug, Dose and Duration

For this study, the drug "Sunthi,Suddha Guggulu and Godanthi" has beentaken on the ratio of 1:2: 1 and prepared inthe form of Churna and administered inthe dose of 2 gms thrice daily along withwater for 6 weeks.

Criteria ofInclusion

Age between 12 years to 60 years,chronicity between 6 weeks to 5 years,morning stiffness, Arthritis of 3 or morejoint areas, Arthritis of hand joints,Symmetrical Arthritis, Rheumatoidnodules, Serum Rheumatoid factor,Radiographic changes.

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CLiNICIAL EFFICIACY .

Criteria of Exclusion

Age below 12years and more than 60years, Chronicity less than 6 weeks morethan 5 years, Gout, Osteo-Arthritis,Tubercular Arthritis, GonorrhealArthritis/syphilitic Arthritis, Arthritiswith malignancy, Acute pyogenicarthritis, Psoriatic arthritis,Osteomyelitis, Rheumatic Fever,Ankylosing spondylitis, Arthritis withserious complications, Bursitis,Osteoporosis, Diabetic Arthritis.

Gradation of Parameters with specificscores for the assessments of results

For assessment of the results aspecial scoring pattern has been adoptedfor individual parameters. Beforetreatment and after treatment, data onsigns/symptoms and other parameterstaken into account for diagnosis and forassessment of result of treatment will betabulated and analyzed using suitablestatistical methods.

Subjective Scores

I. Morning StiffnessI. Severe patient can not rise from bed for few hours 6II. Moderate patient cannot rise from bed for few hours in morning

or evenmg 4iii. Mild - can rise from bed but feels difficulty 2

2. Pain on restI. Severe excruciating pain with painful cries 9ii. Moderate frequent complaints of pain 6iii. Mild - reveals pain on asking 3

Objective

3. Pain on motioni. Severe - Excruciating pain with painful cries 9ii. Moderate - Frequent complaints of pain 6iii. Mild - Reveals pain on asking 3

4. SwellingI. Severe - Considerably above the landmarks and with positive

fluctuations 15ii. Moderate - Covering bony landmarks 10iii. Mild - Not masking bony landmarks 5

5. TendernessG4-Will not allow touching 20G3-Winces and withdraws 15G2- Winces on touch 10G1- Patient says the joint is tender 5

6.Muscle Power (whole assessable)GO No contraction 20

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H. M. L. Meena et al.

G I - Flicker of contraction 8G2 - Movement of a joint possible with gravity eliminated but not possible

Against gravity 6G3 - Muscle contraction possible only against gravity 4G4 - Muscle contraction possible against gravity and resistance combined 2G5 - Normal power 0

7. Restriction of joint motion (of movable joints)Fullyrestricted 6Partially restricted 3No restriction 0

8. Subcutaneous nodulePresent 2Absent

9. Functional StatusGrade IV No contraction 6Grade III Flicker of contraction 4Grade II Movements with gravity 2Grade I Contraction possible against gravity and resistance 0Grade 0 Normal power

10. FeverPresent 2Absent 0

II. Elevated E.S.R. (Ist hour)71 mm or more 641 mm - 70 mm 420 mm - 40 mm 2o mm - 20 mm 0

12. Digestive impairmenta. Constipation

Regularly 3Frequently 2Occasionally 1

b. Loss of appetiteAppetite lost 2Poor appetite 1Normal appetite 0

c. AnorexiaNo inclination for diet 2Less inclination for diet INo anorexia 0

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CLiNICIAL EFFICIACY .

The score in points from 2 to 7 will bemultiple according to number ofinvolvement ofjoints. As such the score maybe more than 100. The percentage of reliefmay be calculated accordingly. Forillustration total score before treatment 250,if reaches 150 after treatment the percentageof relief will be 250-150 xlOO = 40%

250

Classification of the Results

Good Response- 75% and above relief insymptomatology & Lab. Parameterstending towards normalcy.Fair Response- 50% and above relief inpresenting symptomatology &Significant improvement in laboratoryparameters.Poor Response- 25% and above relief inpresenting symptomatology &Insignificant improvement in lab.Parameters.No Response- No relief in symptomatol -ogy and no improvement in lab.Parameters.Withdrawal from the study-

Discontinuation of the treatmentduring the trial, development of anyserious complication, aggravation of thedisease & any pronounced toxicity of thedrug.

Follow up details-I" follow-up2nd follow-up3rd follow-up

After two weeksAfter four weeksAfter six weeks

Observation of study

The majority of patients 12 in eachwere registered under the age groups 31-40 yrs and 51-60yrs (25.53% each)(Table-I). Maximum 37 (78.72%) caseswere females (Table-II). 30 (63.82%)

cases were registered as per the durationof illness, under up to 730 days(Table-III). Maximum 21 (44.68%)number of cases were of Vata- PittajPrakriti (Table -IV).maximum 19(40.42%) cases were desk workers(Table- V). Majority of patients 19(40.42%) were illiterates as compared toeducated sections (Table- VI).

Out of 47 cases studied, 15 (31.91 %)cases got good response, 15 (31.91 %) gotfair response, 8 (17.02%) got poorresponse and 03 (6.39%) cases did not getany response, while 06 (12.77%) caseswere dropped out from the study(Table -VII).

Based on numerical score before andafter treatment Percentage of relief wasassessed. 47.40% relief was found on overall parameters. In each parameter, 36.36%of relief in morning stiffness, 70.08% inPain on rest, 57.11 % in Pain on Motion,67.81 % in Swelling, 59.62% inTenderness, 54.77% in Muscle power,47.86% in Restricted movements, 50.00%in Sub cutaneous nodules and 43.21 %relief in Functional status, 40.00% infever, 40.00% in constipation, 42.31 % inloss of appetite, 58.33% in anorexia,3.80% in ESR were found (Table- VllI).

By the statistical analysis (Student Ttest), Clinical Recovery of the drug of"Sunthi +Guggulu+ Godanti Bhasma"was found highly significant (P<O.OO1) inrelieving morning stiffness, pain onmotion, swelling on joints, tenderness,muscle power, restriction of joint motionand Anorexia; only significant effect«0.025) was found in loss of appetite andstatistically insignificant effect wasobserved (P<O. 1) in treatingSubcutaneous nodule, fever, Constipationand ESR - (Table-VIII).

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H. M. L. Meena et al.

Table -1Showing the incidence of age group

Age group in years

Up to 20 21-30 31-40 41-50 51-60

03 9 12 II 12

Table -IIShowing the incidence of sex

Sex

Male

10

Female

37

Total

47

Table-IIIShowing the duration of illness

Duration of illness in days

Up to 365 366-730 731-1095 1096-1460 1461-1825 Total

15 15 3 5 9 47

Table-IVShowing the incidence of Sariraka & Manasika Prakriti

Sariraka Prakriti Manasika Prakriti

v P K VP VK PK S* T S R T S ST RT SR

Total

21 16 10 47 21 10 16 47

V= Vata, P=Pitta. K=Kapha. VP= Vatapitta. VK= Vatkapha, PK=Pittakapha. Sr Sannipat.SsSatwa. R-Rajas. T'Tamas, Sli-Satwarajas. S'Ii Satwatamos. R'I'-Rajastamas, SI -Sama

Table-VShowing incidence of Occupation

Occupation

House wifeNo. of patients

Desk work

F. W. with physical labour

15

19

13

Total 47

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CLiNICIAL EFFICIACY .

Table -VIShowing incidence of Educational Status

Educational StatusIlliterate

Read & write

Primary School

Middle School

High School

College

19

07

05

060802

Total 47

Result of treatment

Sex Good Fair Poor I NoLAMN Total

Resp. Resp. Resp. Resp. Drop Out

Table-VIIShowing the Overall Result of treatment

Male 5 4 0 I \0

Female 10 11 8 2 6 37Total 15 15 8 3 6 47

Table-VIIIShowing the effect of therapy in signs and symptoms

Symptoms S.D. S.E. PValue

Morning < 0.001stiffnessPain on rest 38.82 11.62 27.21 70.08% 39 16.50 2.64 10.30 < 0.001Pain on 43.56 18.68 24.88 57.11% 41 14.83 2.32 10.74 <0.001MotionSwelling on 47.80 15.39 32.41 67.81% 41 23.67 3.70 8.77 < 0.001jointsTenderness 59.80 24.15 35.65 59.62% 40 23.30 3.68 9.68 < 0.001Muscle 45.60 20.63 24.98 54.77% 40 15.48 2.45 10.20 < 0.001powerRestriction of 16.71 8.71 8.00 47.86% 21 9.74 2.12 3.77 < 0.005joints motionSubcutaneous 2.00 1.00 1.00 50.00% 2 1.41 1.00 1.00 >0.1noduleFunctional 4.50 2.56 1.94 43.21% 36 1.76 0.29 6.64 < 0.001statusFever 0.37 0.22 0.15 40.00% 41 0.76 0.12 0.13 >0.1Constipation 0.73 0.44 0.29 40.00% 41 0.96 0.15 0.96 <0.1Loss of 0.63 0.37 0.27 42.31% 41 0.67 0.10 2.56 < 0.025appetiteAnorexia 0.59 0.24 0.34 58.33% 41 0.57 0.09 3.80 <0.001ESR 4.16 4.32 -0.16 -3.80% 38 0.25 0.36 -0.43 >0.1

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H. M. L. Meena et al.

DiscussionIn this study, the effect of Sunthi,

Guggulu, and Godanthi on Amavata wasobserved carefully, in the improvement ofclinical symptoms, complications andreduction in the ESR levels.

Sunthi (Zinziber officinale) is havingKapha Vata Samaka property due to itsKatu Rasa. Snigda Cuna and UshnaVeerya. It has Sotha Pras am an a,Jwaraghna and Vedana Sthapanaproperties. It is also useful inAgnimandhya, Aruchi and Adhmana (Ref-Bh. Pr. Ni.). In Charaka Samhita, Sunthihas been as Sothahara drug (Ref. Ch. Chi.12/21,22,23,25,27).

Guggulu (Balsamodendron Mukul) ishaving Vatahara property due to itsMadhura Ushna, Snigda and PichhilaGunas, Kaphahara property due to Tikta,Katu and Teeksna Gunas and Pithaharaproperty due to Kasaya and MadhuraGunas.

It has Vedana Sthapana, Sothahara,Dcepana, Rasayana and Balya propertiesand used in Amavata, Sandhivata,Vib a n d h a, Agnimandhya and allVatavyadhis (Ref- Bh. ProNi:). It is provedas hypolipidaemic, atherosclerotic, antiarthritic, anti-inflammatory and antiRheumatic action (Ref- Database,CCRAS).

Go d a nth i (Calcium sulphate)(CaSo)Hp) is having Vata Pithaharaproperties and acts as Jwaraghn a,Sulahara and Balya. (Ref. P.Y.Sarma Vol-II).

Hence, the synergetic action of theabove drugs can be corroborated in gettingsigni ficant results of this clinical study.

In Ayurveda Guggulu, the oleo gumresin of Boswellia serrata Roxb is used forthe treatment of rheumatism and the

activity has attributed to the presence ofpentacyclic triterpenoid acid (Guptaet.aI.1987). Guggulu an oleo gum resinhas been in use for a variety of metabolicdisorders including Rheumatoid Arthritis(Satyavati, 1969). The therapeuticproperties of Commiphora mukul(Guggulu) have been reviewed by Bhatt(1987). Vyas and Sukla (1987), testedpurified Guggulu for its anti-rheumaticactivity. 'Zinziber officinale (Sunthi) isdescribed in Ayurvedic system of medicineto be useful in inflammation andrheumatism and its mechanism of action isreported to be related to inhibition ofProstaglandin (Sreevastava, 1992). InAyurveda "Godanthi" established asSu lah ara, Jwa ragh na, Balya andVatahara. Clinical trials with Sunthi,Guggulu and gum Guggulu with goldshowed much improvement in patients ofRheumatoid Arthritis (Ref- CDRI,Lucknow- 1987).

Conclusion

After going through the statisticalanalysis of the data, we may conclude that,the study has shown significantimprovement on Amavata. There wasimprovement in all the subjectiveparameters and also observedimprovement in walking time, pressingpower and grip strength. Further regularstudy is required over a large number ofcases to draw a definite conclusion.

Acknowledgement

The authors are very much thankful tothe Director CCRAS, New Delhi, for hisboundless co-operation andencouragement. We are also thankful to thepatients who co-operated with us duringthe study.

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CLiNICIAL EFFICIACY .

References

1. Dwaraka N ath, C . Introduction to KayaChikitsa, publishedby Chowkamba Sanskrit SamsthanVaranasi.

2 Madhavakar 1968 (MadhukoshaCommentary), Publishedby Choukhamba Sanskrit Sansthan,Varanasi and 6th edition.

3 Murthy K.R.Srikantah 2001 Madhava Nidanam (EnglishTranslation) 4th edition, Published byChoukhamba Orientalia Varanasi.

4 Mahajan, B.K. 1977 Methods in Bio-statistics, 6th edition,published by Jaypee brother's Medicalpublishers (p) Ltd., New Delhi.

5 Sharma, P.V 1975 Dravyaguna Vignanam, published byChowkamba Vidya Bhavan, Varanasi.

6 Nisteswar K. 1987 Dravyaguna Prayoga Vijnanamu,published by Indian Medicineindustries, Vijayawada

7 Babu,G. 2006 Monograph on Amavata (RheumatoidArthritis)

8 Bharti ct.a\. 2005 Journal of Research in Ayurveda andSiddha Vol. XXVI: No. 3-4, July - Dec.

9 Sarangadhara 1961 SarangadharaSamhita, published by SriBaidyanath Ayurved Bhavan Pvt. Ltd.Calcutta-6.

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