HTML Full Text

Introduction

Amavata is basically made up of a combination of two words, Ama and Vata5. The disease is mainly caused due to derangement of Agni like Jatharagni, Dhatvagni and Bhutagni etc. ensuing in the production of Ama and this Ama gets circulated in the complete body by means of the vitiated Vata and thus gets positioned in the Shleshmasthana (Amashaya, Asthisandhi etc) inflicting pain, stiffness and swelling over the small and big joints making a person feel like lame6. In this way, the virulent Ama which when gets circulated in the whole body, gets propelled by the vitiated Vata Doshas, which in turn leads to blockage in the body channels, that in turn stations itself in the Sandhi giving rise to Amavata7. Ajeerna in turn helps to increase the production of Ama & along with Vata, it thus produces Amavata. The scientific presentation of Amavata closely mimics Rheumatoid Arthritis, which is basically a continual inflammatory, unfavourable and deforming symmetrical polyarthritis related with systemic involvement. The prevalence of rheumatoid arthritis in India in person has been mentioned to differ from 0.5 to 3.8% in women and from 0.15 to 1.35% in men. Allopathic treatment although provides symptomatic relief but the underlined pathology remains untreated due to absence of effective therapy, which in turn rise to many side effects, toxic symptoms and adverse reactions. The Ayurvedic treatment thus not only devoid such type of sick effect, but also presents a higher way by treating Agni and Ama at its roots. The concepts of administration of Amavata as per our classics are langhana, Swedana, Dravyas having Tikta, Katu Rasa, Deepan Pachana as Shamana chikitsa. We all know, that the first specified description of Amavata as a sickness is observed in Madhav Nidan.

AIMS AND OBJECTIVE :-

Primary Objective - To determine the clinical efficacy of Amvatari Rasa and Ajmodadhi Churna in the management of Amavata w.s.r. to Rheumatoid Arthritis.

Secondary Objective :- To determine the clinical safety of Simhnad Guggulu  in the management of  Amavata w.s.r. to  rheumatoid arthritis

MATERIALS AND METHODS

Selection of the Patient :- The patients are selected  from the OPD of DAC Jalandhar Punjab. A sample of 36 patients were selected, two left the study and finally 17 patients in each group were assessed in the clinical study.

Study Design /Study type – Randomized clinical trial

Masking - Single blind

Timing - Prospective

Number of patients - 32 (16 in each group)

No of Groups -2

Duration of trial – 42 days

Follow up visit - After every 14 days till the completion of trial

Diagnostic Criteria: The patients were diagnosed based on clinical features of Amavata as well as Rheumatoid Arthritis, as per American College of Rheumatology (ACR) , Rheumatoid Arthritis can be diagnosed with the help of following criteria:-

1. Morning stiffness
2. Arthritis of three or more joint areas
3. Arthritis of hand joints
4. Symmetrical Arthritis
5. Rheumatoid nodules
6. Serum Rheumatoid factor
7. Radiographic changes

Out of above seven, atleast four of the criteria, should be present in patient for more than or equal to 6 weeks in order to meet the diagnosis of Aamvata.

Inclusion Criteria

1. Patients in the age group between 30 - 70 years, irrespective of gender and socioeconomic status were selected for this study.
2. Patient with signs and symptoms of Amavata w.s.r. to Rheumatoid Arthritis as described in texts and fulfil the diagnostic criteria.

Exclusion Criteria

1. Patients with age group below 30 and above 70 years.
2. Pregnant and lactating mothers
3. Any Malignancy
4. Patients having any type of arthropathy such as neoplasm of spine, ankylosing spondylosis, osteoarthritis, traumatic arthritis and pyogenic osteomyelitis etc.
5. Patients suffering from chronic renal, respiratory, cardiac and hepatic disorders.
6. Patients having history of taking any anticoagulant/antiplatelets were also excluded from this trial.

Investigations

1. TLC, DLC, ESR, Hb gm%
2. Serum uric acid, RA Factor
3. FBS, Blood Urea, Serum Creatinine, SGOT, SGPT, Urine Rout

ine and microscopic examination

Grouping of Patients: Study was conducted randomly on 32 patients in two groups (16 patients in each group). Group II was managed with Amvatari Rasa and Ajmodadhi Churna ,while Group I was managed with Simhnada Guggulu.

1 patient dropped out from Group I and Group II, due to failure of taking treatment as per our standards. These 2 patients were excluded from the present clinical study. Hence the effect of therapy was studied on 30 enrolled patients.

a. Drug -Aamvatari rasa

 Dose:- 2 tab BD

Anupana :- Lukewarm water

b. Drug-Ajmodadi churna

Dosage- 3gm thrice in a day

Route of administration- Oral

Anupana- Lukewarm water

c. Drug- Simhnada Guggulu

 Drug dosage 500mg thrice in a day

Route of administration-Oral

Assessment Criteria

Subjective Criteria- These are the subjective criteria given in the classical texts.

1.  Angamarda
2.  Aruchi
3.  Trishna
4.  Alsaya
5.  Gauravata
6.  Jwara
7. Agnimandya
8. Jadya
9. Sparshasahtva
10. Sandhishoola
11. Sandhishotha
12. Vidvibandha
13. Nidraviparaya

Objective Criteria: All the routine laboratory investigations were done along with diagnostic Hematological Investigations like CBC, ESR, SGOT/SGPT, B.Urea, S.creatinine and blood sugar estimation is done for the safety profile of the patient before treatment and after treatment. C -reactive protein (CRP titer) Rheumatoid factor (RA titer)

Final assessment of Results :-

Statistical Analysis: Data obtained during the trial was tabulated and statistically analysed using Student Paired ‘t’ Test. The result was categorized significant or insignificant depending upon the value of p. Highly significant p value <0.001, Significant, p value <0.05, Insignificant p value >0.05

There was a statistically significant decrease (p value= 0.031) in Angamard . In group II only 41.9 % decrease in Angamarda was observed after the therapy which was statistically significant (p value= 0.03). In group I only a 66.8% decrease in Aruchi was observed after the therapy which was statistically significant (p value= 0.031). There was a statistically highly significant decrease (p value = 0.031) in Aruchi by 51.9% in group II. There was a statistically significant decrease (p value=0.018) in Trishna by 45.6% in group I. In group II only 43.8 % decrease in Trishna was observed after the therapy which was statistically significant (p value = 0.02). In group I only a 52.9% decrease in Alasya was observed after the therapy which was statistically highly significant (p value= 0.032). Whereas in group II, 39.9 % decrease was observed with p value= 0.04 which was statistically significant. There was a statistically highly significant decrease (p value<0.001) in Gauravata by 57.89% in group I. In group II only a 60.99 % decrease in Gauravata was observed after the therapy which was statistically highly significant (p value <0.001). In group I only 23.9% decrease in Jwara was observed after the therapy which was statistically insignificant (p value =0.58). In group II only 23% decrease in Jwara was observed after the therapy which was statistically insignificant (p value=0.47). In group I only 76.8% decrease in Agnimandya was observed after the therapy which was statistically highly significant (p value=0.031). There was a statistically significant decrease p value= 0.03 in Agnimandya by 55.9% in group II. There was a statistically significant decrease (p value=0.04) in Sparsh Ashyata by 45% in group I. In group II only 44% decrease in Sparsh Ashyata was observed after the therapy which was statistically significant p value = 0.03. There was statistically highly significant decrease (p value<0.001) in Sandhi Shoola by 67% in group I. In group II only 64.1% decrease in Sandhi Shoola was observed after the therapy which was statistically significant (p value=0.032). There was statistically significant decrease in Sandhi Shotha by 60% with p value = 0.04 in group I. In group II only 75.2% decrease in Sandhi Shotha was observed after the therapy which was statistically highly significant (p value = 0.051). There was a statistically significant decrease (p value=0.03) in Vidvibandha by 43% in group I. In group II only 39.8% decrease in Vidvibandha was observed after the therapy which was statistically significant (p value=0.04). There was a statistically significant decrease (p value=0.02) in Nidravipraya by 46% in group I. In group II only 43.89% decrease in Nidravipraya was observed after the therapy which was statistically significant (p value=0.02). In the present study, no considerable change was noticed in Hb, TLC, DLC, FBS, blood urea and serum creatinine after treatment in both the groups, except ESR and CRP. In ESR there was 24.92%reduction in group I and 19.4% in group II. Both groups showed statistically significant result with (p value<0.05). In CRP Percentage of relief were 27.93% and 25.2% percentage respectively in Group I and Group II the result in both groups were statistically significant (p<0.05). Inter group comparison revealed that result was statistically insignificant in both groups.

Discussion

All the maximum contents of the proposed drugs are Katu-Tikta Rasa and Ushana Virya Pradhana, which in turn have Deepana-Pachana property. Due to Agnimandya at the level of Jatharagni or Bhutagni, Rasadhatu and Anna were not digested properly and this forces them to turn into Ama11... At this stage, Simhanada Guggulu , Aamvatari Rasa and ajmodadhi rasa  shows the Amapachana effect. All the general pharmacodynamic properties of drug i.e Laghu, Tikshna, Ruksha Guna,Tikta Rasa and Ushana Virya are against the Guru Snigadha Picchila and Sheeta  properties of Ama. Ama formation is stopped by the Deepneeya action. Associated symptoms Like Vidvibandh and Anaha are reduced by Anulomana i.e purgative properties of the drugs. simhnad  Guggulu, relieves the symptoms of  Sandhishoola and Shotha by analgesic and anti-inflammatory action. The type of Sangha Strotodushti that occurs in Amavata gets treated with the help of the properties of the proposed drug like Laghu, Ruksha and Ushana Virya that helps to remove Strotokleda, Shodhana and Klednashakaguna.

Almost all these drugs have Ushana Virya, Laghu Ruksha Guna,Amahara, Deepana Vatakaphahara and Shotha,Shoolghana properties.By the Ushna Ruksha and  Laghu Guna,it does the Pachana of  Ama, which is seated in local  Sandhis. Shandhi shotha in Amavata is brought about by the accumulation of Kapha Dosha and Ama. This Amapachana properties of all these drugs, further does the liquefication of Ama, leading to Sroto Vikasa by its Ushana Guna, which in turn enhances circulation, that is further helpful in moving Ama from Sandhi into circulation leading to Sthabdata nasha and thus the joint movements come to normal.

Conclusion

The following conclusion may be drawn based on observations and analysis made in the clinical study The trial dugs Aamvatari Rasa and Ajmodahi churna Churna showed statistically significant results in subjective parameters Angamarda, Trishna,Apaka, Jadya, Sparsh Ashyata, Vidvibandha and Nidravipraya. The objective parameter i.e CRP, ESR showed statistically significant results in both groups but  the maximum decrease was observed in Group II..In addition to these parameters, the trial drugs  simhnad Guggulu and ajmodadi  churna also showed significant results in SGOT.

Hematological and other  biochemical  investigations i.e TLC, DLC, blood urea, serum creatinine, SGPT and Serum lipid profile remained within normal range in both the groups after the completion of the trial drugs.No adverse effects of  simhnad guggulu, amvatari rasa and ajmodadi churna   were reported during the trial period.Thus on the basis of the present clinical study it was concluded that  Amvatari rasa along with ajmodadi churna is more efficient than simhnad guggulu alone  in improving signs and symptoms of Amavata patients.