A CLINICAL TRIAL ON ARNOPEN CAPSUlES(ANUBHUTA YOG) IN AMAVATA

(RHEUMATOID ARTHRITIS)

Dr. R.R.VASHISTHA Ph.D.Medical Suptt. H.O.D(Panchakarma Dept.)

Dr. BASANT KUMAR M.D.(Ayu.)

CHAUDHARY DEVllAl AYURVEDIC COllEGE AND HOSPITAL

JAGADHARI, YAMUNA NAGAR (HARYANA)

INTRODUCTION:-

AMAVATA- The factors influencing Amavata are ama and vata . Amaisthe end product of impaired digestion/metabolism, iscarried by vayuallover the body and reaches to the joints. Finally it obstructs the bodychannels at different sitesand causes the inflammation of joints. Now,the condition has been termed as Amavata.

In Ayurveda AMAVATA iscompaired as Rheumatoid arthritis.

Rheumatoid arthritis (R.A.)isan autoimmune systemic disorderwhere in the body defence mechanism identifies the normal tissuesasantigen and evokes a chain of inflammatory reaction resulting indestruction. It affects the joints commonly like wrist, hands, knees, ankle,foot and fingers. Involvement of soft tissuestructures surrounding thejoint too occurs like synovial capsule, tendons, muscles etc. Oxidativestressisa major factor in the pathogenesis of rheumatoid arthritis asindicated by higher concentration of free radicals in synovial fluid.

Clinical features (lakshan) of Amavata:-

ljody ache - Angamarda

Feeling of Heaviness - Garav

Inflammation of the body parts - Sunayata Anganum

Fever- Jwara

Anorexia - Aruchi

Thirst- Trishna

r'"\ni,ni",p _.. /.\11"1<:('1'.1('1• y .--." •••••••• ,~ _ I ., ••••~oJ •••••• ) _

Indigestion - Apaka

Aim of Treatment:-

1. Toevaluate the effect of Arnopen capsule in amavata.

Amavata treatment principles :-According ToAcharaya chakradatta the Amavata treatmentshould be done by Langhna ( fasting), Svedana(steaming),Virechna ( purgation) Snehanan(massage etc.),Anuvasana basti(unctous enema) and kshara basti .

Internally the drugs possessingRasa (taste)-Tikta(bitter),Katu(pungent) and Deepan (enhance metabolic secretions) areindicated.Thus the anubhut yog ARNOPENcontains theingredient are selected which possessingRasa(taste)-Tikta(bitter)& katu(pungent).

Rheumatoid Arthritis is prevalent in the yo~~g and middleaged population. In spite of so called most effective treatmentavailable nowadays, it cripples the patient for th~}rest of his life. So itshows that the disease need to be a drug should be selected whichhelps the patient to live his life normally and smoothly by keeping this inview Anubhuta Yog Arnopen capsule prepared to see the efficacy of1hiscompound in the patient of amavata (R.A.).

Systemic features of R.A.

• Low grade fever, malaise, fatigue and joint poin.• Jointsare swollen edematous} warm, tender with effusion and the

movements are painful and restricted.• Earlymorning joint stiffness.• Synovial thickening isappreciable.• Subcutaneous nodules may be palpable.

DRUG REVIEW

DRUG NAME BOTANICAL TASTE POTENCY METABOLISM ACTION

SOURCE (RAS) (VIRAYA) (VEEPAKA) (KARMA)

MAHAYOGRAG GENERIC Tikta Ushna Katu Tridoshshamak

GOOGAL Katu (Heating) (Pungent)

Kashay

CHITRAK PLUAMBAGO Katu Ushna Katu Tridoshshamak

ZEYLANCIA Tikta (Heating) (Pungent)

i-

NIRGUNDI VITEX Katu Ushna Katu VatKaphnashak

NEGUNDO Tikta (Heating) (fungent)_. ._-RASANA PLUCHA Katu Ushna Katu VatKaphnashak....

LANCEO (Heating) (Pungent)LATA-

SAMEERPANANG GENERIC Tikta Ushna Katu Kaphvatnashak

I (Heating) (Pungent)

KHURASINIOWA HOSYAMUS Katu Ushna Katu Vedanashamak

NIGER Tikta (Heating) (Pungent)

KUNDRU Bosewallia Katu . Ushna Katu Vedanashamak

serrato Tikta (Heating) (Pungent)

MAHAYOGRAJ GUGGAL:- It is said to digest metabolic toxins (ama) andimproves joint functions and .reserves the orthro system.

Guggal Qualify:-(vatashamak) ,Shothghan (Antiinflamatory) ,Analgesic (vednashamak)

CHITRAK (PLUAMAGO ZEYLAMCIA):- Anti -inflammatory role of chitrokhas been observed.(2) It Helps collagen induced arthritis in mice. (Ref-3)(3) Anti-oxidant activity of chitrok is also reported.(Ref-3)

NIRGUNDI (VITEX NEGUNDO):- Higher concentration of free radicalshas been reported in synovial fluid in inflammatory diseases.

The oral administration of Nirgundi extract has been reported to exert positiveeffect on bringing anti-oxidant levels to normal level in adjuant inducedarthritic rat.

(J Rheumatology, 1981) )

RASNA (PLUCHA LANCEO LATA): Attenuates cadmium chloride inducedoxidative stress.(6)Rasna also exhibits significant ant-inflammatoryactivity.(7}itsextract inhibited the production of ROS( Reactive Oxygenspecies) in the stimulated human neutrophies.(ref-8)

SAMEERPANANG:- It strengthens muscle tendons and ligaments andalso potentates anti-inflammatory effects of other drugs.

KHURASINI OWA (HOSYAMUS NIGER):- It is believed'to act as a musclerelaxant.

KUNDRU(BOSEWLLlA SERRATA):-It restores integrity of blood vessels&builds collaterals.

Dignostic Criteria:-

1. Morning stiffness (stabdhata).2. Pain on movements/ tenderness (sparsasahyata).3. Swelling(shotha).4. ESRabove 40mm /1 sf.

5. R.A.factor positive.6. Fever(Local riseof temprature).

Material and Methods:- 40 patients of Amavata(rheumatoid arthritis)were selected from the OPD AND IPDOFC.D.L.College & Hospital,Jagadhari.

INCLUSIVE CRITERIA: Patients were selected on basis of DignosticCriteria.

Age between 22-40 years.

EXCLUSIVE CRITERIA: Patients with positive uric acid were excluded fromhe study.

RELIEFIN MORNING STIFFNESS--No. Of B.T. / A.T/15 A.T/ 30 AJ/ 45 A.T /60 AJ/90Patient M.S. days days days days days

s14 20 min 10 min 5 min Omin o min o min19 15 min 5 min o min o min o min Omin4 10 min 5 min o min o min o min Omin3 5 min o min o min o min o min o min------• BT - Before Treatment, M_S.- Morning Stiffness, A.T. - After Treatement

CHANGES IN ESR----

No. Of B.T. / AJ/ 15 AJ/30 AJ /45 A.T /60 AJ/90Patient ESR. days days days days days

s07 60 50 40 20 08 0615 42 28 16 14 12 1210 48 32 14 06 05 058 50 40 28 15 15 12

In 7 patient esr before treatment was 60mm/1 hr was change to .06mm/l hr ,In 15 patient before treatment (B.T) 42 mm/1 hr was reducedto 12mm/1 hr ,in 10 patient BTwas 48 mm/1 hr was re'duced to 05mm/1 hr ,in 8 patient 8T was 50 and reduced to 12 mm/1 hr after 90 days oftreatment.

CHANGES IN R.A. FACTOR

Days 15 30 days 45 60 days 90 daysdays days

NO.of Patients 0 02 06 07 25

In all the patients the RA factor was found weakly positive after 90 daystreatment.

IMPROVEMENT IN APPETITE

[_._.. _.Days d~5s 30 days d~5s 60 days .__90 days

L No~ Of Pa!ients 25 15 0 0 0 __After 15 days of treatment in 25 patients appetite was improved, in 15patients apr=,etite was improved in 30 days with ARNOPEN cap.

FAllOW UP: Patient were followed after 15,30,45,60,90days from the 151

day of treatment started.

AGE AND SEX DISTRIBUTION:

AGE NO.of Patients Male Female22-40years 40 17 23

Total 40 patients were selected out of which 17were males 23 werefemales.

DOSAGE SCHEDULE: Only ARNOPENcapsules 2 tid for one month and 2bid for next 2 months with hot water were prescribed.

OBSERVATION

1) Improvement in Pain, Inflammation, Reduction in Morning Stiffnesswere observed in all patients during follow up period of15,30,45,60,90days.

2) ESRtest and R.A.factor test were carried out in all the patients on1sl day of trial and on each follow up.

RESULTS:Subjective improvement in pain, inflammation, morningstiffnessand appetite were evaluated.

IMPROVEMENT IN INFLAMMATION

[-~_:_- 3019

457

60 90

After 15days of treatment in 14patient inflammation was relievedcompletely, in 19patients after 30 days and in 7 patients inflammationr relieved after 45 days with ARNOPENcaps.

IMPROVEMENT IN PAIN

Days 15 30 45 60 90NO.of 10 15 12 3 - --

PatientsAfter 15days treatment the pain relieved completely in 10patients, in15patients after 30 days, in 12patients after 45 days and in 3 patientsofter 60 days with ARNOPENcap.

CONCLUSION:-

1) Pain, inflammation, morning stiffnessand appetite showedremarkable improvement within 15to 45 days in the majority ofcases acc. to severity.

2) ESRreached to normal range acc. to male, female ratio that islessthan 10mm/lSt in males and lessthan 20mm/lSt hr in femaleas shown in the table.

3) In all the patients the RAfactor was found weakly positive after 90days.

4) No untoward adverse effects were observed with ARNOPENcapsules.

Moreover, it isconcluded that the presence of bitter andastringent taste present in ARNOPENingredients makes it powerful freeradical scavenging agents.

Overall, ARNOPENcapsules were found to be very effective inthe treatment of Amavata ( rheumatoid arthritis).

SUMMARY:

]) Arnopen offers complete relief from pain & associated problems inRheumatoid arthritis (Amavata) after 3 months treatment.

2) It is free from any side effect .No side effects were observed in anypatient during trial.

3) Arnopen can be used as preventive when started in earlier stageof Amavata (Rheumatoid arthritis).

ARNOPEN Capsules IS A DRUG OF CHOICE FOR AMAVATA AS WELLASRHEUMATOID ARTHRITIS

REFERENCES:-

Mohoyogoj guggol ref:-Bharat Bhaishajya Ratnakar Part 4 Siok No. 5780

OTHER:-

I<aso

1.Hui Linda, K.Banburry, Centre for PPhyto.&Pharma. China,2007.

2. Pharmaceutical Bioiogy,43,2005

3. Pharmaceutical Biology,45,2007

4. Redox Report,9,2004

5. J.Rheumatology, 1981

6. Jehangir,T. et 01., J.Pharm. &Pharmaco.,2005

7. F.Perez-Garcia, et 01. Phytomedicine,12,2005

8. Vocabulary:- Ushon(Hot) , veeryo(potency). vipoko(end product of digestion/metobolisom),

(taste), Guno(quolity), Kormo(mode of action), Shomoko(olleviotor),va tokophonashok (votko pho

olleivitor). vedonoshomok(onolgesic),