To compare the effect of maharasnadi yoga basti and vaitarna basti in treatment of amavata
- Conditions
- Osteopathic. Ayurveda Condition: AMAVATAH,
- Registration Number
- CTRI/2025/05/086334
- Lead Sponsor
- Dr Jyothika Gupta
- Brief Summary
**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 Vikara*1 which is composed of 2 words *Ama*2 and *Vata.*
*Amavata* is first mentioned as a separate disease in *Madhava Nidana*3, where it is stated that *Mandagni* is the main cause for the manifestation of the disease. It is produced mainly due to vitiation of *Vata*4 along with the accumulated *Ama* and then occupies into *Shleshmasthana* which results in *Amavata*. It produces symptoms like *Sandhishotha, Sandhishula,*
*Sandhistabdhata, Sparshashatva, Aruchi,* *Alasya, Gaurava*5, 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 *Panchakarma*8 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 V*eerya* 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 Basti*11in 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 Kashay*a12 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 Taila*13 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 TAILA***13
| | | | | |
| --- | --- | --- | --- | --- |
|**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 groups**GROUP A:** 20 Subjects will receive *Maharasnadi Yoga Basti.*
**GROUPB**: 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.
| | | |
| --- | --- | --- |
| **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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
Patients will be selected by classicalk signs and symptomsof amavata patients will be selected irrespective of their gender and caste patients aged between 20 to 60 years patients fit for basti karma chronicity less thasn 5 years.
All autoimmunue other than rheumatoid arthritis pregnant women and lactating mothers any systemic disorders which interfere with the course of the treatment uncontrolled hypertension and diabetes mellitus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of maharasnadi yoga basti in the management of amavata 6 months
- Secondary Outcome Measures
Name Time Method To compare the efficacy of maharasnadi yoga basti and vaitarana basti in the management of amavata 6 months
Trial Locations
- Locations (1)
Shree jagadguru gavisiddheshwara ayurvedic medical college koppal
🇮🇳Koppal, KARNATAKA, India
Shree jagadguru gavisiddheshwara ayurvedic medical college koppal🇮🇳Koppal, KARNATAKA, IndiaDr Jyothika GuptaPrincipal investigator9480963512jyothikagupta746@gmail.com