A Comparative Clinico-Pathological Study on CRP Positive Patients W.S.R. to Amavata (Rheumatoid Arthritis) and it’s Management with Vatari Guggulu and Pathyadi Churna

Abstract

Introduction- C-Reactive Protein (CRP) is an acute-phase of inflammatory protein, a highly conserved plasma protein that is named for its reaction with the capsular C-polysaccharide of Pneumococcus.1 It is an Annular (Ring-shaped) Pentameric protein found in blood plasma, whose circulating concentration rise in response to inflammation and of hepatic origin that increases interleukin-6 secretion by macrophages and T-cells.2 Due to this type of inflammatory changes there are stiffness, Pain, Swelling of joints along with generalized symptoms of fever etc. present in the disease like Amavata (Rheumatoid Arthritis). Materials and methods- 30 patients of Group-A (15) and Group-B (15) patients were registered from OPD and IPD of Govt. Ayurvedic College & Hospital, Balangir presented with Subjective Parameter as Sandhi Ruja, Sandhi Shotha, Sandhi Stabdhata, Jwara, Aruchi and Daurbalya and Objective Parameter as CRP>6mg/L, ESR, Hb%, DLC,TLC and Lipid profile test. After diagnosis they were under trial with Ayurvedic formulations of Vatari guggulu given 500mg thrice daily after food in Group A and Pathyadi Churna given 5gm twice daily after food with ushnajala for a period of 30 days with respectively. The subjective and objective parameters were assessed in 10 days interval to interpret the result by statistical evaluation. Observation and results:- It has been observed that the result of trial drug Group-A patients is Significant (p<0.05) to reduce both Subjective and Objective parameter after 30 days of treatment as campair to Group-B patients. Conclusion- CRP positive patients suffered from Amavata (Rheumatoid Arthritis) showed Significant improvement after receiving the Ayurvedic formulation ‘Vatari Guggulu’ in this study. No adverse effect was observed.

Introduction

I. INTRODUCTION

Amavata was described for the first time in Madhava Nidana by Madhavkara in 7th A.D. as a separate disease entity and has also mentioned that Ama and Vata plays a vital role in the pathogenesis of this disease. Amavata is the particular type of disease which is mentioned in Ayurveda under the category of Vata-Kaphaja disorder. The main causative factor Ama is caused due to derangement of Agni especially Jatharagni.3

This disease is initiated by the consumption of Virudha Ahara (incompatible food) in the pre-existence of Mandagni. In it vitiated Vayu forcefully circulates the Ama all over the body through Dhamnies (circulatory channels) which take shelter in the Shleshma sthana (Amashyas, Sandhi etc.)

In Rheumatoid Arthritis producing symptoms such as Stiffness, Bodyache, Anorexia, Polydipsia, Lassitude, and Heaviness in body, Fever, Indigestion of food, Swelling of the body.4 In the later stage pain may begin to migrate from place to place with a Vrishchika Danshnavat Vedana (intense stinging type of pain) and burning sensation. CRP with pathological Rheumatic factors are present in this type of disease.

Penicillin is an effective drug to treat Rheumatoid Arthritis and there is changing to decrease CRP titre, but still remains     challenging due to its adverse reaction and drug sensitivity. As per classical reference, Vatari Guggulu and Pathyadi Churna are a miraculous Ayurvedic formulations used for pain, swelling along with non suppurative inflammatary disease and autoimmune diseases. So an attempt is being taken to use there drugs of choice for CRP positive patients in Amavata (Rheumatoid Arthritis) for clinical trial.

A. Aim And Objective Of The Study

1. To review the literature on CRP titre related to Ayurveda classics.
2. To evaluate clinical effect of Vatari Guggulu and Pathyadi Churna in high level of CRP titre in Amavata (Rheumatoid Arthritis).
3. To correlate the disease Amavata in relation to the signs and symptoms of modern diseases Rheumatoid Arthritis where CRP is positive.

II. MATERIALS AND METHODS

A. Selection of Patients

The total 30 patients (Group-A 15, Group-B 15) had been selected by a special proforma covering demography along with both Subjective and Objective parameters from OPD and IPD of Govt. Ayurvedic College and Hospital, Balangir and Saradeshweri Govt. Ayurvedic Hospital Balangir. The consent of patient was also taken before clinical trial.

B. Inclusion criteria

1. Patient with more than normal CRP level>6.0 mg/L
2. Patient’s age between 12-60yrs of both sexes.
3. Patients having clinical features of Rheumatoid Arthritis and Amavata CRP positive selected for this study.

C. Exclusion Criteria

1. Age <12 and >60 years.
2. Patient having systemic illness like Hypertension, Hypotension, Heart disease, Tuberculosis, Severe anemia, HIV and Carcinogenic growth in body were excluded from the study.
3. Patients who have undergone recent surgeries.
4. Patients taking immunosuppressive medicines like Steroids etc.
5. Pregnant woman and lactating mother.

D. Criteria for Investigations

CRP, ESR, Hb%, DC, TLC and Lipid profile tests were investigated initially and during follow up periods.

E. Selection of Drug

Two trial drugs i.e. Vatari Guggulu and Pathyadi Churna had been taken for clinical trial. The drugs of both medicines were identified by the experts of Dept. of Dravyaguna and Rasashastra and Bhisajya Kalpana which were approved by DRC and IEC of College and Sambalpur University. Medicines were prepared in the GMP certified Mini Pharmacy of College under the supervision of expert of Rasashastra and Bhisajya Kalpana. The Sample of Research Medicine were sent to Quality Control Laboratories, KOPPA, Dist. Chikmagalur, Karnataka for their Analitical study.

Table No.01:Showing the Pharmocodynamics of drug of  Vatari Guggulu and Pathyadi Churna

Dose- Patients were advised to take Vatari Guggulu 2 tabs (500mg) thrice a day (1.5gms) and Pathyadi Churna 1tsf (5gm) twice daily after food both with ushnajala  for 30 days in Group-A and Group-B respectively.

F. Assessment Criteria-

The Subjective parameters and Objective parameters as per Inclusion Criteria were assessed by the grading score from 0 to 3 according to the severity of diseases and favorable shift to back. Both parameters were followed up 10th, 20th and 30th day of medication. The overall assessments were done considering the percentage relief of both parameters and statistical evaluation.

III. OBSERVATION AND RESULTS-

The Clinical study period of 30 patients were taken from 06/08/2020 to 20/03/2021. Within aforesaid period the demography (Table No.02) based on Age-Sex-Religion etc. along with incidence of Dasvidha Pariksha (Table No.03) were observed and assessed.

Table No.02: Demography Incidence of Registered Patients. (n=30)

Table No.03: Incidence of Dashvidha-Pariksha of Registered Patients.

The Subjective and Objective parameters of both Group-A and Group-B were observed during clinical study. The percentage of improvement were also observed and assessed after clinical trial. (Table No.04)

Table no. 04: Total Patients as per disease and Percentage of Improvement in Group-A and  Group-B. (n=15)

After observation of subjective and objective parameters, the statistical analyses of parameters were assessed by the helping statistical method. (Table No.05)

IV. DISCUSSION

Amavata can be co-related with Rheumatoid Arthritis. The clinical presentation of Amavata closely related with the special variety of Rheumetological disorders called Rheumatoid Arthritis (R.A.). The main clinical features of Rheumatoid Arthritis like Pain, Swelling, Stiffness, Fever, and general debility can be compared with clinical features of Amavata as mentioned in Ayurvedic Classics. But the Nidana of Amavata does not co-related with Rheumatoid Arthritis as it is an Auto-immune disease. The Samprapti of Amavata co-related with Rheumatoid Arthritis as in both the type of Srotodusti is Sanga.

The detail of Amavata was discussed in the form of Nidana, Purvarupa, Rupa, Upasaya, Samprapti and treatment which are described in Lagutrayi classical books. All these features were teken into consideration for this study as well as etiology, pathogenesis, clinical features and treatment described in modern science were also followed during research work.

The aim of present study was the effect of Vatari Guggulu and Pathyadi Churna on CRP Positive patients in “Amavata (Rheumatoid Arthritis)”. Vatari Guggulu was a classical yoga which contains Sudha Gandhak, Sudha Guggulu, Eranda tail, Amalaki churna, Vibhitaki churna, and Haritaki churna selected from Bhaisajya Ratnavali and Pathyadi Churna was also a Classical yoga which contains Haritaki, Sunthi and Yavani (Ajwain) from Cakradatta. The whole study was performed in two groups i.e. Group-A treated with Vatari Guggulu and Group-B treated with Pathyadi Churna.

Predominant rasa of Vatari Guggulu is katu, tikta, kasaya rasa having madhura and katu vipaka. Mainly katu, tikta and kasaya rasa act on Kapha dosha whereas Madhura Vipaka helps in alleviation of vata dosha. The drugs also poses ushna Veerya act on kapha and vata dosha. Laghu, ruksha and tikshana guna act as kapha shamaka and snigdha guna act as vata Shamaka. This drug is predominantly Tridoshahara. It contains Deepana Pachana properties.

Predominant rasa of Pathyadi Churna is katu, tikta, kasaya rasa having madhura and katu vipaka. Mainly katu, tikta and kasaya rasa act on kapha dosha whereas madhura vipaka helps in alleviation of vata dosha and katu vipaka helps in alleviation of kapha dosha. The drugs also poses ushna veerya act on kapha and vata dosha. Laghu, ruksha guna act as kapha shamaka. This drug is predominantly Vatakaphahara. It contains Deepana Pachana properties.

It was observed from demographical study (Table No.02) that most of the patients were from Middle aged (46-60 years), female (70%), Hindu (90%) , Married (83.33%), Housewives (56.67%) having middle class socio-economic status (80%), addiction with tea- smoking (83.33%, 26.67%), Disturb sleeping habit (60%), Abnormal bowel habit (76.67%) and mixed variety dietary habits affected due to non-maintenance of hygienic lifestyle and dietic habit.

It was observed that maximum numbers of patients were having Vata-kapha prakriti (60%) with the predominance of madhyama satwa-sara-samhanana-satmya-pramana, and predominance of Avara aharashakti-vyayama shakti and Madhyama Vaya.

From the above Table No.04, It was observed that Patients treated with Vatari Guggulu (Group-A), was statistically significant(P<0.05) improvement in Subjective parameters symptoms like Sandhi Ruja (56.10%), Sandhi Shotha (56.41%), Sandhi Stabdhata (58.54%), Jwara(61.54%), Aruchi(61.54%) and Daurbalya(61.11%). In Objective parameters CRP (55.88%) was also observed Statistically Significant (P<0.05).

In Group-B  patients treated with  Pathyadi Churna, was observed statistically not significant (P>0.05) improvement in subjective parameters like Sandhi Ruja(31.71%), Sandhi Shotha(31.71%), Sandhi Stabdhata(34.15%), and Jwara(30.56%) and other subjective parameters like Aruchi(51.43%) and Daurbalya(51.28%) was observed statistically significant (P<0.05). In objective parameters CRP (44.44%) was observed statistically significant (P<0.05) but less than Group-A patients.

Regarding Serological Findings improvement was noticed equally statistically significant (P<0.05) in both Group-A and Group-B. but more improvement was revealed in Group-A

It was revealed that, P-Values (P<0.05) for Objective parameters were statistically significant in both Group-A and Group-B. Further it showed that, mean rank for Group-A was greater than Group-B and effect of Vatari Guggulu (Group-A) was more than Pathyadi Churna (Group-B).

Further it was observed that, mean rank for Group-A was greater than Group-B. The overall percentage of improvement in Group-A (57.99%) is more than Group-B (38.47%). Hence it was revealed that, effect observed in Group-A is more than Group-B.

As regards to CRP, it was revealed that, P-Value is less than 0.05 and mean difference for Group A is greater than Group B. Hence it conclude that, effect observed in Group-A was better than Group-B.

Table No.06; Showing Clinical Assessment of Result in Group-A and Group-B

In assessing overall effect of therapy, it was seen that:

• Overall comparison showed that best results was obtained in Group-A (Vatari Guggulu) in the form of better clinical response and statistical significance.
• Present study reveals that the selected Vatari Guggulu drug has potential effect on Amavata with the added advantage of being free from side effects.

V. ACKNOWLEDGEMENT

I am very much grateful and thankful to Dr. G.B. Acharya, H.O.D Dravyaguna, Dr. S.B. Behera, H.O.D Rasashastra & Bhaisajya Kalpana, Dr. Manoj Kumar Sahu, H.O.D. Samhita & Sidhanta, Dr. Vinod Chandra Singh, Lecturer, RNVV, Dr. Manoranjan Sahu, Lecturer, RNVV for their grateful blessings. I am also thankful to Dr. Dusmanta Kumar Majhi, Dr Bishnupriya Lenka, Dr. Esha Dhiman, Dr. Saumyaleena Baral,  and Dr. Madhusmitarani Sethi all my P.G. Scholars friends, Hospital Staff and other Staff of RNVV dept. for their constant helping attitude to complete the research work with a full satisfaction and belief.

Conclusion

CRP positive patients suffered from Amavata (Rheumatoid Arthritis) showed significant improvement in Subjective and Objective parameters after receiving the Ayurvedic formulation ‘Vatari Guggulu’. So ‘Vatari Guggulu’ has provided significant result in improving signs and symptoms and decreased the levels of CRP in Amavata (Rheumatoid Arthritis) patients. Pathyadi Churna shows no response and no improvement in Subjective parameters like Sandhi Ruja, Sandhi Shotha, Sandhi Stabdhata and Jwara. Pathyadi Churna showed response and significant improvement in Subjective parameters like Aruchi, Daurbalya and Objective parameters like CRP, ESR and Hb%. Present study was carried out with certain limitations like fewer samples. Forth coming researchers may pursue further study in a large sample size over a period of longer duration. No side effect was noticed during clinical trial in both the groups.

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Copyright

Copyright © 2023 Dr. Mohammed Faisal Quazi, Prof. (Dr.) Pradip Kumar Panda, Prof. (Dr.) Arun Kumar Das, Dr. Utkalini Nayak. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.