A randomized control clinical study to evaluate the efficacy of maharasnadi yoga basti and vaitarna basti in the management of amavata (rheumatoid arthritis)

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

S.NO

INGREDIENTS

BOTANICAL NAMES

PARTS USED

PARTS

|1

Rasna

Alpinia galanga

Patra

2  Parts

|2

Dhanvyasa

Fagonia cretica

Panchanga

1 Part

|3

Bala

Sida cordifolia

Mula

1 Part

|4

Eranda

Ricinus communis

Mula

1 Part

|5

Devadaru

Cedrus Deodara

Kanda Saara

1 Part

|6

Sathi

Hedychium spicatum

Kanda

1 Part

|7

Vacha

Acorus calamus

Mula

1 Part

|8

Vasa

Adhatoda vasica

Mula

1 Part

|9

Nagara

Zingeber officinale

Kanda

1 Part

|10

Pathya

Terminalia chebula

Phala

1 Part

|11

Chavya

Piper chaba

Phala

1 Part

|12

Mustha

Cyperus rotundus

Kanda

1 Part

|13

Punarnava

Borrehewia diffusa

Mula

1 Part

|14

Guduchi

Tinospora cordifolia

Kanda

1 Part

|15

Vriddhadaru

Ipomoea petaloidea

Mula

1 Part

|16

Shatapushpa

Anthum graveolens

Beeja

1 Part

|17

Gokshura

Tribulus terrestris

Phala

1 Part

|18

Ashwagandha

Withania somnifera

Mula

1 Part

|19

Prativisha

Aconitum ferox

Mula

1 Part

|20

Kritamala

Cassia fistula

Phalamajja

1 Part

|21

Shatavari

Asperagus racemosus

Kanda

1 Part

|22

Krishna

Piper longum

Phala

1Part

|23

Sahachara

Barleria prionitis

Kanda

1 Part

|24

Dhanyaka

Coriandrum sativum

Phala

1 Part

|25

Brihati

Solanum indicum

Mula

1 Part

|26

Kantakari

Solanum zyelanicum

Panchanga

1 Part

|27

Jala

Water

16 Parts

TABLE NO. 2 MURCHITA TILA TAILA13

S.NO

INGREDIENTS

BOTANICAL / COMMON ENGLISH NAMES

PARTS USED

PARTS

|1

Manjishta

Rubia cordifolia

Mula

½ Pala

|2

Haridra

Curcuma longa

Kanda

1 Karsha

|3

Lodhra

Symplocos racemosa

Twak

1 Karsha

|4

Musta

Cyperus rotundus

Kanda

1 Karsha

|5

Nalika

Hibiscus cannabinus

Twak

1 Karsha

|6

Amalaki

Emblica officinalis

Phala

1 Karsha

|7

Haritaki

Terminalia Chebula

Phala

1 Karsha

|8

Vibhitaki

Terminalia bellerica

Phala

1 Karsha

|9

Suchipushpa

Pandanus odorifer

Mula

1 Karsha

|10

Vatankura

Ficus bengalensis

1 Karsha

|11

Hribera

Pavonia odorata

Mula

1 Karsha

|12

Tila taila

Sesamum indicum

400 ml

|13

Jala

Water

1600 ml

TABLE NO. 3:   COMPOSITION OF MAHARASNADI YOGA BASTI

S. NO

Ingredients

Botanical / English Name

In Pala

In ml / gm

|1.

Makshika

Honey

3 Pala

144 ml

|2.

Saindhava

Rock Salt

1 Karsha

12 gm

|3.

Tila Taila

Sesamum indicum

2 Pala

96 ml

|4.

PutoYavanadi Kalka

 1 Pala

48 gm

|5.

Maharasnadi Kashaya

 4 Pala

192 ml

| Total

  480 ml

Anuvasana Basti with Murchita Tila Taila - 72ml

TABLE NO. 4: VAITARANA BASTI

S NO.

Ingredients

In Pala

In ml/gm

|1

Guda

1/2 Pala

24 gm

|2

Saindhav Lavana

1 Karsha

12 gm

|3

Murchita Tila Taila

1 Pala

48 gm

|4

Chincha Kalka

1 Pala

48 gm

|5

Gomutra

1 Kudava

192 ml

| Total

324 ml

                                                                                   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 groupsGROUP A: 20 Subjects will receive Maharasnadi Yoga Basti.

GROUPB: 20 Subjects will receive Vaitarana Basti.

III)  SELECTION CRITERIAA. 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.

GROUP A

GROUP B

|POORVAKARMA

Anuvasana Basti

Sarvanga Abhyanga with Murchita Tila Taila followed by Swedana.

Sarvanga Abhyanga with Murchita Tila Taila followed by Swedana.

|Asthapana Basti : Sarvanga Abhyanga with Murchita Tila Taila followedby Swedana

|PRADHANAKARMA

Administration of Maharasnadi Yoga Basti

Administration of Vaitarana Basti

|PASCHAT KARMA

For Anuvasana : Sphik Tadana Mardana of soles and palms*.*

Pratyagamana Kala nirikshana

Sukoshnajalasnana

Laghu Ahara Sevana

|For Asthapana :Pratyagamana Kala nirikshana

Sukoshnajalasnan  Laghu Ahara Sevana

 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:

TREATMENT SCHEDULE

GROUP –A

GROUP – B

|Treatment duration

 8 days

8 days

|Parihara kaala

 16 days

16 days

|Total study duration

 24 days

24 days

7.3  ASSESMENT CRITERIA

I. SUBJECTIVE PARAMETERS

1.      Sandhishoola

Pain in Joint

Score

|No pain

00

|Mild pain of a bearable nature, comes occasionally

01

|Moderate pain, but no difficulty in joint movement, appears frequently

02

|Slight difficulty in joint movements due to pain or severe pain

03

|More difficulty in moving the joints and pain is severe, disturbing sleep

04

2.      Sandhistabdhata

Stiffness of the joint

Score

|No stiffness or stiffness lasting for 5min

00

|Stiffness lasting for 5 min to 2 hrs

01

|Stiffness lasting for 2 to 8 hrs

02

|Stiffness lasting for more than 8 hrs

03

3.      Sandhishotha

Swelling

Grade

|No complaints

00

|Slightly obvious

01

|Covers well over the bony prominence

02

|Much elevated

03

4.      Sparshashatva

Tenderness of  joints

Score

|No tenderness

00

|Subjective experience of tenderness

01

|Wincing of face on tenderness

02

|Wincing of face on withdrawal of affected parts on pressure

03

5.      Ushnata

 

Warmth of joint

Score

|Normal temperature

00

|Fall in local warmth

01

|Raised temperature when compared to the normal surface

02

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 brieflyYes,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.