BRIEF RESUME OF THE INTENDED WORK:

 6.1      NEED FOR THE STUDY:

Amavata is one of the most common and crippling disorders of the joints. It is a Rasa Pradoshaja Vikara¹ which is composed of 2 words Ama² and Vata.

Amavata is first mentioned as a separate disease in Madhava Nidana³, where it is stated that Mandagni is the main cause for the manifestation of the disease. It is produced mainly due to vitiation of Vata⁴ along with the accumulated Ama and then occupies into Shleshmasthana which results in Amavata. It produces symptoms like Sandhishotha, Sandhishula,

Sandhistabdhata, Sparshashatva, Aruchi, Alasya, Gaurava⁵, etc.

It can be correlated with Rheumatoid Arthritis in Contemporary Science based on similarities of the Lakshanas. It is a chronic, progressive autoimmune disorder with a prevalence rate of 0.3 - 2% of the adult population world wide⁶ and people are getting gradually crippled physically as well as mentally. It is more common in females as compared to males with a ratio of 3:1⁷. It is characterized by bilateral symmetrical involvement of joints and systemic clinical features. The Chikitsa Siddhanta of Amavata has been described by Acharya Chakradatta which includes Langhana, Swedana, Deepana with Katu-Tikta Dravyas, Virechana, and Basti.

Basti Chikitsa is considered to be a prime treatment modality among the Panchakarma⁸ and is advocated as Ardha Chikitsa in Ayurveda. It is the best procedure to control the vitiated Vata Dosha. It is the prime Dosha which has the capacity to wander from one place to another. Pitta and Kapha Dosha are dependent on Vata Dosha as it governs their functions in the body⁹. Due to the inherent Veerya of Basti Dravya, it spreads all over the body just like water poured into the root of a tree it reaches the whole plant¹⁰. Basti plays a major role in the management of Amavata where both Anuvasana as well as Asthapana Basti are recommended. Acharya Chakradatta has explained the role of Vaitarana Basti¹¹in the management of Amavata. Vaitarana Basti possesses Katu Rasa, Katu Vipaka, Ushna Virya, Laghu, Ruksha, and Tikshna gunas which pacifies the Kapha Dosha. In addition, it does Agnideepana, Pachana, Srotovishodhana, and Vatanulomana.

The most important step after the selection of the route of intervention is formulation. The drugs selected should target the Samprapti Vighatana of Amavata. Maharasnadi Kashaya¹² a formulation comprising 26 drugs is a contribution of Sharangdhara Samhita and has been indicated in the treatment of Amavata. The majority of the drugs in Maharasnadi Kashaya have Snigdha Guna, Ushna Veerya, and Vata Kapha Shamaka properties. Moreover, these drugs possess anti-inflammatory, analgesic, and antioxidant properties.

Hence in this study, Vaitarana Basti and Maharasnadi Yoga Basti are compared to evaluate the effect of Amavata.   

 6.2  REVIEW OF LITERATURE

1.      The wide description about Amavata will be reviewed from Laghutrayees.

2.      Description about Vaitarana Basti will be reviewed from Chakradatta.

3.      Descriptions about Maharasnadi Kashaya will be reviewed from from Sharangdhara Samhita.

4.      Murchita Tila Taila will be reviewed from Bhaishajya Ratnavali.

5.      Rheumatoid Arthritis will be reviewed from Modern text books and authenticated Journals and Internet.

 PREVIOUS WORK DONE :

1.      Bhople Sunanda, Gulhane Harshad – A Clinical study on the effect of Vaitarana basti in the management of Amavata. – MUPS Ayurvedic college and hospital, Risod, India - 2021.

2.      Kaushik J, Kumar A, Yadav P "Role Of Vaitarana Basti In The Management Of Amavata W.S.R. To Rheumatoid Arthritis - A Case Study" IRJAY.[online] 2021;4(12):67- 73.

3.      Sheetal G. Lodha and Ruchika S. Karade. Clinical evaluation of Vaitarana Basti along with Dhanwantara Taila Matra Basti in Amavata: A Case Series. Int. J. Res. Ayurveda Pharm. 2020:11(6)

4.      Sourabh Gupta, M.A. Hullur. A Comparative Clinical Study in the Management of Amavata w.s.r to Rheumatoid Arthritis through Kshara Vasti and Vaitarana Vasti along with Shamanoushadhi. AYUSHDHARA, 2020;7(5):2882-2894.

5.      Abhinav, Namjoshi Pradnya Vasant. Vaitarana vasti: A specific treatment modality for Amavata (Rheumatoid arthritis). Int. J. Res. Ayurveda Pharm. 2015;6(2):178-181.

 6.3 OBJECTIVES OF THE STUDY:

·         To evaluate the efficacy of Maharasnadi Yoga Basti in the management of Amavata.

·         To evaluate the efficacy of Vaitarana Basti in the management of Amavata.

·         To compare the efficacy of Maharasnadi Yoga Basti and Vaitarana Basti in the management of Amavata.

 6.4 HYPOTHESIS

·         H₀- There is no significant difference in the effect of Maharasnadi Yoga Basti and Vaitarana Basti in the management of Amavata.

·         H₁- There is a significant effect of Maharasnadi Yoga Basti over Vaitarana Basti in the management of Amavata.

·         H₂- There is a significant effect of Vaitarana Basti over Maharasnadi Yoga Basti in the management of Amavata.

 7 MATERIALS AND METHODS

7.1 SOURCE OF DATA:

A) Literary Source:

It will be reviewed from Laghutrayees, contemporary texts, authenticated Journals, and the internet.

B)  Sample Source:

Patients suffering from the Amavata will be selected from the OPD of SJGAMC Hospital, Koppal.

C)  Drug source:

Maharasnadi Kashaya¹² and Murchita Tila Taila¹³ drugs will be collected and identified by the Dravyaguna Department and prepared in the Rasashastra and Bhaisajya Kalpana Department of SJG Ayurvedic Medical College and Hospital PG studies, Koppal according to the standard procedure mentioned in classics.

 TABLE NO. 1 MAHARASNADI KASHAYA

TABLE NO. 2 MURCHITA TILA TAILA¹³

 TABLE NO. 3:   COMPOSITION OF MAHARASNADI YOGA BASTI

    Anuvasana Basti with Murchita Tila Taila - 72ml

   TABLE NO. 4: VAITARANA BASTI

 7.2 METHOD OF DATA COLLECTION

I) STUDY DESIGN:

An open-label randomized controlled clinical study. 

II) SAMPLE SIZE AND GROUPING:

A minimum of 40 subjects will be selected for the study and they will be randomly allocated in 2 groups

GROUP A: 20 Subjects will receive Maharasnadi Yoga Basti.

       GROUP B: 20 Subjects will receive Vaitarana Basti.

III)  SELECTION CRITERIA

A.           DIAGNOSTIC CRITERIA

a.       Patients presenting with classical signs and symptoms mentioned in Ayurveda Sandhishotha, Sandhishula, Sandhistabdhata, Sparshaashatva, Aruchi, Alasya, Gaurava, etc.

b.      The criteria laid down by the 2010 ACR-EULAR (American College of Rheumatoid Arthritis¹⁴⁾, the following features are employed for the confirmation of RA:

1)             Have at least 1 joint involvement with definite clinical synovitis.

·                 1 large joint involved- 0

·                 2-10 large joints involved -01

·                 1-3 small joints (with or without the involvement of large joint)-02

·                 4-8 small joints (with or without the involvement of large joints)-03

·                 More than 10 large joints with one small joint involvement -04

2)            Serology

·                   Negative RF and negative ACPA -0

·                   Low positive RF / Low positive ACPA- 2

·                   High positive RF / High positive ACPA-3

3)             Acute phase reactants (at least 1 result is needed for classification)

·                   Normal CRP and Normal ACPA-0

·                 Abnormal CRP and abnormal ESR-1

4)             Duration of symptoms

·                    < 6 weeks -0

·                    >/= 6 weeks -1

A patient with a score of > 6 is classified as having rheumatoid arthritis (RA).

            B.      INCLUSION CRITERIA

1.  Patients will be selected by classical signs and symptoms of Amavata.

2.  Patient will be selected irrespective of their gender and caste.

3.  Patients aged between 20 to 60 years.

4.  Patients fit for Basti Karma.

5.  Chronicity less than 5 years.

C.         EXCLUSION CRITERIA

1.          All autoimmune disorders other than Rheumatoid Arthritis.

2.          Pregnant women and lactating mothers.

3.          Any systemic disorders which interfere with the course of the treatment.

4.          Uncontrolled Hypertension and Diabetes Mellitus.

D.           STUDY GROUPS :-

Koshta Suddhi- Sadyo Virechana with Nimbamruthadi Castor oil 15- 30 ml based on Agni and koshta of patient.

E.            SCHEDULE OF BASTI 

·         For Maharasnadi Yoga Basti: Yoga Basti pattern for 8 days.

·         For Vaitarana Basti : continuously to be given for 8 days.

F.            METHOD OF PREPARATION

                      As per Basti Samyojana Vidhi according to classics.¹⁵

G.           STUDY DURATION:

 7.3  ASSESMENT CRITERIA

                                 I.            SUBJECTIVE PARAMETERS

1.      Sandhishoola

2.      Sandhistabdhata

3.      Sandhishotha

4.      Sparshashatva

5.      Ushnata

                              II.            OBJECTIVE PARAMETRS

1)      RA factor test

2)      ESR

3)       Hb %

7.4 STATISTICAL TEST

Subjective and Objective parameters of baseline data before treatment, after treatment, and after follow-up will be compared to assess the result using Wilcoxon signed rank, Mann Whitney U test, and paired T-test.

7.5 INVESTIGATIONS:

·   RA Factor

·   ESR

·   Hb%

7.6 Does the study require any Investigation or intervention to be conducted on patients or humans or animals? If so, please describe it briefly

Yes, Study requires human intervention. 

7.7 Has Ethical Clearance been obtained from your institution?

        Obtained and enclosed

   8.        LIST OF REFERENCES

1.      Acharya Trivikramatmajena Yadhava Sharmana, Editor, Madhukosha Commentary of sri Madhavakara on Madhava Nidana, Amavata Nidana adhyaya; chapter 25, verse 5. Varanasi: Chaukamba Orientalia, 2017, p.187

2.      Madhavakara, Madhav Nidan, The Madhukosha Sanskrit Commentary by Sri Vijayraksita and Srikanthadatta and The Vidyotini Hindi Commentary by Sri Sudarsana Sastri. Edited by Prof Yadunandan Upadhyaya, (M.N 25/1).Chaukhambha Prakashana, Revised Edition Reprint-2009, Varanasi, Pg. no.508.

3.      Acharya Vaidya Yadavaji Trikamji Editor (6th ed.). Madhukosha Sanskrit Commentary on Madhava Nidanam of Madhavakara (Vol 2), Chapter 25, Verse 4-5. Varanasi: Chaukhamba Orientalia, 2001; 187.

4.      Madhavakara, Madhav Nidan, The Madhukosha Sanskrit Commentary by Sri Vijayraksita and Srikanthadatta and The Vidyotini Hindi Commentary by Sri Sudarsana Sastri. Edhed by Prof. Yadunandan Upadhyaya, (M.N 25/2). Chaukhambha Prakashana, Revised Edition Reprint-2009, Varanasi, Pg.no.508

5.      Madhavakara, Madhav Nidan. The Madhukosha Sanskrit Commentary by Sri Vijayraksita and Srikanthadatta and The Vidyotini Hindi Commentary by Sri Sudarsana Sastri, Edited by Prof Yadunandan Upadhyaya, (M.N 25/4-5). Chaukhambha Prakashana, Revised Edition. Reprint-2009,Varanasi, Pg. no.509

6.      Fauci Anthony S, Braaunwald Eugene, Ksaper Dennis L, Hauser Stephen L, Longo I, Dan, et al. Editors, Harrison’s Principles of Internal Medicine, 17th Edi. NewYork: McGraw Hill 2012;2:783,

7.      Maxine A. Papadakis, Stephen J.McPhee, Micheal W. Rabow, Current Medical Diagnosis & Treatment 2020 edited by McGraw-Hill vith Deepana, Publications, chapter -20 Vol-1, p-852

8.      Chakrapanidatta, Chakradatta, Vaidyaprabha Hindi Commentary by Acharya Ramanath Dwivedi, edition, Varanasi, Chaukhambha Publication, Amavataadhikara 25/52-56; 2002. p. 171.

9.      Sharanghdhara Samhita edited by Shailaja Srivastava, Chaukhambha Orientalia, Varanasi, Reprint edition-2011 Shr. Pu. Kh. 5/25.

10.  Sushruta, Sushrutasamhita, edition, Varanasi, Sushrutavimarshini Hindi commentary by Sharma Anantram, Chaukambha Surabharati Prakashan, Chikitsasthana 35/25; 2008.

11.  Chakradatta by Indradeva thripati,chapter no 73/32,Choukamba sanskrith Bhavana, Varanasi edited in 1997,pageno 455.

12.  Dr. Bramhanada Tripathi editor, (1st edition). Commentry Dipika on Sarangadhara Samhita of Sarangadhara, Madhyamkhanda; rikwath kalpana: Chapter no. 2, Verse No. 3,5, Varanasi: Chaukhamba Surbharti Prakashan, 2013; pg 90.

13.  Bhaisajya Ratnavali by prof. Siddinandana Mishra 5/1268, Chaukambha surbharati Prakashana, Varanasi edited 2016, page no=206.

14.  Aletaha D., Neogi, T., Silman, A.J. Funovits, J. (2010), 2010 Rheumatoid arthritis classification criteria: An American College of Rheumatology/ European League Against Rheumatism collaborative initiative, Arthritis & Rheumatism, 62: 2569-2581.

15.  Chakradatta by Indradeva thripati,chapter no 73/32, Choukamba sanskrith   Bhavana, Varanasi edited in 1997,pageno=455.