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ORIGINAL ARTICLE
Year : 2016  |  Volume : 37  |  Issue : 2  |  Page : 105-112  

Clinical evaluation of efficacy of Alambushadi Ghana Vati and Vaitarana Basti in the management of Amavata with special reference to rheumatoid arthritis


Department of Kayachikitsa, National Institute of Ayurveda, Jaipur, Rajasthan, India

Date of Web Publication7-Nov-2017

Correspondence Address:
Ram Kishor Joshi
Department of Kayachikitsa, National Institute of Ayurveda, Jaipur - 302002, Rajasthan
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ayu.AYU_91_15

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   Abstract 


The clinical presentation of Amavata closely mimics with the special variety of rheumatologic disorders called rheumatoid arthritis (RA). The Ayurvedic approach toward the treatment of Amavata is the need of present era as no system is successful in providing the complete cure to this disease. Amavata is a challenging and a burning problem of medical science. Prevalence of RA is approximately 0.8* of the population. Due to wide spectrum of disease, much prevalence in the society, and lack of effective medicine, the disease had been chosen for the study. The aim of the research was to study the efficacy of Alambushadi Ghana Vati and Vaitarana Basti in the management of Amavata (RA). It was a single-center, randomized, open-clinical study. In the present study, 30 clinically diagnosed patients of Amavata were selected and randomly divided into two groups by lottery method. Alambushadi Ghana Vati was given in dose of two tablets (each 500 mg) three times in a day with lukewarm water after meal for 30 days, while Vaitarana Basti on alternate day (15 Basti) had been given simultaneously in the second group along with drug of first group. Statistical analysis was done using InStat GraphPad 3 Software. Wilcoxon matched pairs signed ranks test was used for the analysis of nonparametric data, while paired t-test was used for parametric data analysis and Mann–Whitney test and unpaired t-test were used for intergroup comparison. Statistically highly significant (HS) improvement was found in erythrocyte sedimentation rate, and HS results were found in symptoms of Amavata when the Vaitarana Basti was used along with Alambushadi Ghana Vati. With excellent relief in 20* patients, significant relief in 60* patients, moderate relief in 13.33* patients, whereas mild relief in 6.66* patients. On comparing the effect of two therapies, it can be concluded that Group B (Alambushadi Ghana Vati and Vaitarana Basti) provided better relief than Group A (Alambushadi Ghana Vati) in most of the sign and symptom of the disease at significant level.

Keywords: Alambushadi Ghana Vati, Amavata, rheumatoid arthritis, Vaitarana Basti


How to cite this article:
Sasane P, Saroj UR, Joshi RK. Clinical evaluation of efficacy of Alambushadi Ghana Vati and Vaitarana Basti in the management of Amavata with special reference to rheumatoid arthritis. AYU 2016;37:105-12

How to cite this URL:
Sasane P, Saroj UR, Joshi RK. Clinical evaluation of efficacy of Alambushadi Ghana Vati and Vaitarana Basti in the management of Amavata with special reference to rheumatoid arthritis. AYU [serial online] 2016 [cited 2020 Feb 23];37:105-12. Available from: http://www.ayujournal.org/text.asp?2016/37/2/105/217795




   Introduction Top


In the present era, due to modern life style, hectic work schedule, stress, and many such reasons, incidence of disease is increasing, and one of them is Amavata, which can be compared with rheumatoid arthritis (RA) due to its clinical presentation. The disease is being chosen for the study due to its widespread clinical spectrum, increased prevalence, and lack of effective medicaments. Prevalence of the disease is approximately 0.8% of the population and about 80% of people develop this disease between the age of 35 and 50 years.[1]

According to the nature of disease, it is essential to plan such therapy which has Ama and Vatahara properties. The line of treatment described for the disease in Chakradatta Amavatachikisa Prakarana includes Langhana, Swedana use of Tikta and Katu drugs and if needed Virechana and Basti.[2] This study has been under taken to evaluate role of Shamana drug along with Shodhana therapy (Virechana Basti). Hence, in the present study, “Alambushadi Ghana Vati” has been selected as Shamana Yoga while “Vaitarana Basti” has been selected for study as Samshodhana process.

Aims and Objectives

  1. Clinical evaluation of efficacy of Alambushadi Ghana Vati and Vaitarana Basti in the management of Amavata(RA).



   Materials and Methods Top


Selection of patient

Thirty patients of Amavata were selected from Kayachikitsa OPD and IPD of National Institute of Ayurveda, Jaipur. The case selection was regardless of age, sex, occupation and socio-economic conditions. Both acute and chronic phases of Amavata patients were taken for the study, following the ACR criteria of the diagnosis of RA in modern medicine and the clinical features of Amavata described in Madhava Nidana.[3]

Study design

Present study is single center, open labeled randomized (lottery method) clinical trial.

Inclusion criteria

  1. The patients between the age group of 16–70 years of either sex presenting with the clinical features of Amavata like pain, stiffness and swelling in multiple joints along with features of Ama like loss of appetite, indigestion and fever
  2. Patient diagnosed for RA on the basis ACR criteria
  3. Patient of Amavata (RA) having chronicity <10 years.


Exclusion criteria

  1. Patients of age below 16 years and above 70 years of either sex
  2. Chronicity of Amavata more than 10 years
  3. Patients having severe crippling deformities
  4. Patients suffering from paralysis
  5. Patients having neoplasm of spine, gout, ankylosing spondylitis, traumatic arthritis, and pyogenic osteomyelitis
  6. Patients having associated cardiac disease, pulmonary tuberculosis, diabetes mellitus, malignant hypertension, renal function impairment, etc.
  7. Patients with extremely reduced joint space
  8. Patients with bone deformity.
  9. Pregnant women and lactating mother
  10. Patients contraindicated for Basti as mentioned in Samhitas.


Grouping

A total of 30 clinically diagnosed and registered patients of Amavata were divided randomly by lottery method into two groups. Each group had 15 patients.

  • Group A: 15 clinically diagnosed patients of Amavata were treated with Alambushadi Ghana Vati two tablets (each 500 mg) three times in a day with lukewarm water after meal for 30 days.


Group B: 15 clinically diagnosed patients of Amavata were treated with Alambushadi Ghana Vati two tablets (each 500 mg) three times in a day with lukewarm water after meal for 30 days along with Vaitarana Basti which was given on alternate day (15 Basti) simultaneously. Vaitarana Basti (approximately 200–250 ml), after the meal and Anuvasana Basti (approximately 60–80 ml), after the meal (It was given only to the patients who presented with symptoms of Vata aggravation. It consisted of Tila taila and one pinch of Saindhava mixed well. It was given in the dose of 60–80 ml whenever the patients developed Vata Vriddhi Lakshana while receiving Vaitarana Basti.

Drugs and method of its preparation

Alambushadi Ghana Vati selected in this trial was taken from Chakradutta Amavatachikitsa Prakarana[4] which contains Alambhusha(Lajjalu) (Mimosa pudica Linn.), Gokshur(Tribulus terrestris Linn.), Haritaki(Terminalia chebula Retz.), Bibhitaki(Terminalia bellerica Roxb.), Amalaki(Emblica officinalis Gaertn.), Shunthi(Zingiber officinale Roscoe), Amrita(Tinospora cordifolia(Thunb.) Miers), Trivrutta(Operculina turpethum Linn.) in the proportion of 1:2:3:4:5:6:7:28. Alambushadi Ghana Vati was made of 500 mg each Vati. The materials were procured and prepared in GMP certified pharmacy of the institute (Drug Batch No. A0281).

Ingredients of Vaitarana Basti

Amalika (Emali)(Tamarindus indica Linn.), Guda, Saindhava, Gomutra, and Tila Taila(Sesamum indicum Linn.) in the proportion of 4:2:1:16.

Preparation of Vaitarana Basti

Initially, 20 g (1 Shukti) of jaggery (Guda) was mixed uniformly with equal quantity of lukewarm water and 10 g (1 Karsha) of Saindhava was added. Thereafter, Tila taila was added till the mixture become homogenous (approximately 30 ml). To this 40 g (1 Pala) of Emali Kalka was added carefully and then finally, 160 ml (1 Kudava) of Gomutra was added slowly and mixing untill uniform Basti Dravya was obtained. That was then filtered and Basti Dravya was made lukewarm by keeping it into hot water. Basti was given by proper method in the left lateral position by Basti Yantra, after meals in morning hours.

Criteria for assessment

Subjective parameters

Assessment of sign and symptoms was done pre- and post-trial on severity grading scale for various aspects of disease as developed by Prof. Ram Kishor Joshi et al. [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10], [Table 11], [Table 12], [Table 13], [Table 14].
Table 1: Severity grading scale

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Table 2: Grading of stiffness present in the joint

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Table 3: Grading of swelling present in the joint

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Table 4: Grading of movement

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Table 5: Grading of tenderness present in the joint

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Table 6: Grading of body ache (Angamarda)

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Table 7: Aruchi (anorexia)

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Table 8: Grading of Trishana (excessive thirst)

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Table 9: Alasya (laziness)

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Table 10: Gaurava (heaviness)

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Table 11: Jwara (fever)

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Table 12: Apaka (indigestion of food)

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Table 13: Bahumootrata (frequency of urine micturition per 2 h)

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Table 14: Grading of developed for assessment of in clinical manifestation

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Investigations

For the assessment of effect of therapy and to rule out side effect if any, following investigation were done:

  1. Hematological- Hb gm%, total leukocytes count (TLC), differential leukocyte count (DLC), erythrocyte sedimentation rate (ESR), serum. uric acid, fasting blood sugar level (FBS), RA factor, C-reactive protein (CRP) test, antistreptolysin O (ASLO) titer
  2. Urine routine/microscopic
  3. Radiological X-ray of affected joints.


In this study, serum uric acid was done to exclude Gout which mimic the RA symptoms and random blood sugar level (RBS) was used for screening patients of diabetes.

Observation

Present study had shown that 50% patients belong to the 3rd to 5th decade of life and were formal. Incidence of disease is notably higher in females (73.33%) than in males (26.67%), i.e., (2.7:1) Majority of the patients (76.67%) belonged to Hindu religion; 80% patients were married. Out of which, maximum 50% patients were housewives, followed by 26.67% laborers; about 50% patients belonged to middle class. 46.67% patients were of Vata-Kaphaja Prakriti, 56.67% patients were of Madhyama Sara, 43.33% had Madhyama Samhanana, 56% patients with Madhyama Satmya, 64% patients with Madhyama Satva, 53.33% patients showed Madhyama Ahara Shakti, 53.33% patients showed Avara Vyayamashakti, 50% patients had Madhyama Koshtha, whereas 40% patients had Krura Koshtha and maximum 60% patients had Mandagni. In this type of Koshtha and Agni, there is predominance of Vata and Kapha Dosha, which may play important role in developing the pathogenesis of Amavata.

Maximum 40% of the patients had duration of illness for less then <2 years; 46.67% patients were of taking allopathic medicine; 43.33% patients had positive family history of the disease; maximum 80% patients had CRP; 20% patients had ASLO titer and 16.67% patients had RA factor positive before the treatment; 100% patients had pain, stiffness, swelling of the affected joints. Angamarda and Jwara while; 96.99% patients had tenderness of joint. The 86.66% patients had restriction of movement and 80% of the patients had Alasya; 76.66% had Gaurava;and 60% patients had Trishana before the treatment. Maximum 93.33% of the patients had proximal interphalengeal (hand) joint involvement, 90% metacarpophalengeal and 86.66% had distal interphalengeal (hand) joint involvement other joints affected were wrist joint (83.33%), elbow joint (73.33%), shoulder joint (53.33%), ankle joint (60%), knee joint involvement (43%), metatarsophalengeal (73.33%) and tempomandibular joint 16%.


   Results Top


Effect of therapy on subjective parameters

In Group A, highly significant (HS) results (P < 0.0001) in subjective parameters– like pain in joint (68.35%), stiffness of joint (56.26%), swelling of joint (66.97%), restriction of movement (45.45%), tenderness at joint (59.99%), Angamarda (57.59%), Aruchi (60.88%), Gaurava (44.44%), Jwara (66.69%), Apaka (59.99%) and Bahumootrata 59.98% was found. In case of other subjective parameters, i.e., Alasya, there was significant result (P < 0.05) with percentage relief of 44.44% and Trishna there were nonsignificant results (P > 0.05) with percentage relief of 19.99%. In Group B, highly significant improvement results (P < 0.0001) in all subjective parameters with percentage improvement of pain in joint (77.927%), stiffness of joint (66.67%), swelling of joint (73.11%), restriction of movement (81.80%), tenderness at joint (76.92%), Angamarda (81.80%), Aruchi (80%), Trishna (57.88%), Alasya (79.96%), Gaurava (74.06%), Jwara (78.57%), Apaka (81.50%)and Bahumootrata 80% was reported [Table 15].
Table 15: Effect of therapy in subjective parameters

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Intergroup comparison of Group A and Group B for subjective parameters

Intergroup comparison showed that there was no major difference in efficacy of trial drug of Groups A and B. However, Angmarda (– P < 0.05) which there was statistically significant difference that there is statistical showed that Group A provided better result than Group B [Table 16].
Table 16: Intergroup comparison of Group A and Group B for subjective parameters

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Effect of therapy in objective parameters (laboratory investigations)

In Group A – statistical significant increase Hb% and ESR (P < 0.05) with change of 3.37% and 35.12%, reduction was reported respectively. While other parameter no significant chages were found. However, it remained within normal range.

In Group B, statically highly significant reduction in ESR was found similarly, significant reduction in TLC (13.14%) was also found [Table 17],[Table 18].
Table 17: Effect of therapy on haematological parameters

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Table 18: Inter group comparison on haematological parameters

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Qualitative analysis of RA factor and CRP was done, and on applying statistical analysis, no significant result was found.

Overall effect of therapy

In Group A, excellent relief was found in 6.66% of patients, while significant relief in 46.66%, moderate relief in 33.33%, whereas mild relief in 13.33% of the patients, while in Group B – excellent relief was found in 20% of patients, while significant relief in 60%, moderate relief in 13.33%, whereas mild relief in 6.66% of the patients [Table 19].
Table 19: Overall effect of therapy of the Group A and Group B

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   Discussion Top


Ingredients of Alambushadi Ghana Vati are Alambhusha (Lajjalu), Gokshur, Haritaki, Bibhitaki, Amalaki, Shunthi, Amrita, Trivrutta in the proportion of 1:2:3:4:5:6:7:28, i.e., having highest concentration of Trivrutta with their Kapha Vata Shamaka and Virechana properties thus[5] help in reducing the swelling in the joints.

Also, Katu, Tikta Rasa is dominant in this formulation, thus help in digestion of Ama and finally in breakage of pathogenesis of disease. Besides this, there is dominancy of Laghu, Ruksha Gunas in the Alambushadi Ghana Vati which also helps in Kaphaghna property. Five Dravyas out of eight in the formulation possesses Laghu and Ruksha Guna. This formulation also dominance of drugs Ushna Virya which also helps to pacify the Vata Dosha. In addition of six Dravyas with Shothahara and Anulomana property are also present. With these overall effect of these properties of the drugs of Alambushadi Ghana Vati, Ama and Vata Dosha is treated and thus relief in the cardinal symptoms of the disease was found.

Guduchi is also proved to have antirheumatic, anti-inflammatory, and immunomodulatory properties.[6] While, Sunthi is also proved beneficial for rheumatic and musculoskelatal disorders.[7]Triphala has Rasayana, Tridoshahara, and Virechana properties[8] which helps in reducing the swelling in the joints. Gokshura with its diuretic properties helps to reduce swelling in the joints.[9]

Probable mode of action of Vaitarana Basti

Vaitarana Basti has been mentioned by Chakradutta in Niruhadhikar 73/32. Ingredients of Vaitarana Basti are Amalika (Emali), Guda, Saindhava, Gomutra and Tila taila in the proportion of 4:2:1:16. As a whole, the qualities of Vaitarana Basti can be considered as Laghu, Ruksha, Ushna, Tikshna. Majority of the drugs have Vata Kapha Shamaka action. Owing to these properties treatment with the Basti has provided significant improvement in sign and symptom of disease. The Tikshna Guna of Basti helps in overcoming the Srotodushti resulting due to Sanga, thus help in breaking down the pathogenesis of disease.

Basti therapy may be stimulator for many intraluminal, luminal, and whole body functions. Basti Karma exerts a more systemic action besides exerting local action of operating through large intestine involving enteric nervous system. Enteric nervous system is a collection of neurons in the gastrointestinal tract (GIT) constituting the brain of gut. Apart from its influence on GIT, enteric nervous system also influences the autonomic nervous system thereby producing systemic affect.[10]

Vata is very important Dosha to be managed during treatment of any disease as Acharya told that other Doshas are handicapped without Vata Dosha, and Basti is very important therapy to manage Vata Dosha, and is called as Ardha Chikitsa.[11]

As a whole, the effect of Basti can be summarized as encolonic (action on tissue of colon), endcolonic (action inside colon), and diacolonic (for systemic action). Thus, Basti Dravya after reaching to large and small intestine get absorbed from intestine and due to Laghu, Ushna, Tikshna, and Ruksha Guna of Vaitarana Basti Dravya, it breaks the obstructions and expels out the morbid material from all over the body, thus help in breaking down the pathogenesis of disease.

General observation made during the trial

  1. During the trial, it was observed that in Vata Pittaja Prakriti patients, there was less holding capacity of the Basti Dravya. In these patients, the dose of Gomutra was lowered along with overall Basti quantity to seek the expected results
  2. As Ayurveda is individualized science (Ch. Su. 1/24), every individual has different sensitivity for different contents of formulation, hence cases abdominal discomfort was reported in few cases which was managed by reduction in total quantity of the Basti
  3. Just after Samyaka Basti Nirharana, patient felt very light and enthusiastic.



   Conclusion Top


Finally, comparing the effect of two therapies, it can be concluded that (Alambushadi Ghana Vati along with Vaitarana Basti) provided better relief than (Alambushadi Ghana Vati alone) in most of the signs and symptoms of the disease at significant level.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Harrison TR, Dennis L. Casper, Anthony, Bn Dan L Longo, Eugene Braunwald, Stephen L. Hauser, et al. Harrison's Principles of Internal Medicine. 17th International ed., Vol. 2. Ch. 314. Singapore: McGraw-Hill Book Co.; 2007. p. 2083.  Back to cited text no. 1
    
2.
Tripathi Indradev, editor. Chakradutta of Chakrapani, 1st ed. Ch. 25, ver. 1. Varanasi: Chaukhabha Sanskrit Sansthan; 2012. p. 166.  Back to cited text no. 2
    
3.
Shastri Sudarshana, editor. Madhava Nidana of Madhavakara. 29th ed. Ch. 25, ver. 6. Varanasi: Chaukhambha Sanskrit Samsthan; 1999. p. 511.  Back to cited text no. 3
    
4.
Tripathi Indradev, editor. Chakradutta of Chakrapani, 1st ed. Ch. 25, Ver. 41-43. Varanasi: Chaukhabha Sanskrit Sansthan; 2012. p. 169.  Back to cited text no. 4
    
5.
Chunekar KC, editor. Bhavaprakash of Bhavamisra Guduchyadivarga. 3rd ed. Ch. 3, Ver. 194. Varanasi: ChaukhabhaBharati Academy; 2013. p. 205.  Back to cited text no. 5
    
6.
Manjrekar PN, Jolly CI, Narayanan S. Comparative studies of the immunomodulatory activity of Tinosporacordifolia and Tinosporasinensis. Fitoterapia 2000;71:254-7.  Back to cited text no. 6
    
7.
Sharma PC, Denis TJ, Yelne MB. Database on Medicinal Plants used in Ayurveda. Vol. 1. Reprint edition. New Delhi: CCRAS; 2000. p. 316  Back to cited text no. 7
    
8.
Sastry JL. Dravyaguna Vijnana. Vol. 2. Reprint edition. Varanasi: Chaukhambha Orientalia; 2012. p. 747.  Back to cited text no. 8
    
9.
Anonymous. Ayurvedic Pharmacopoeia of India. 1st ed., Vol. 1. Delhi: Department of AYUSH, Ministry of Health & Family Welfare, GOI; 2003. p. 40.  Back to cited text no. 9
    
10.
Harrison TR, Dennis L. Casper, Anthony, Bn Dan L Longo, Eugene Braunwald, Stephen L. Hauser, J. Larry Jameson, et al. Harrison's Principles of Internal Medicine. Vol. 2. 17th ed., Ch. 39. Singapore: McGraw-Hill Book Co.; 2007. p. 246.  Back to cited text no. 10
    
11.
Shastri K., Chaturvedi GN, editor. Dridhabala, Charak Samhita of Agnivesh, Siddhi Sthana. Reprint edition. Ch. 1, Ver. 38-40. Varanasi: Chaukhabha Bharati Academy; 2003. p. 1169.  Back to cited text no. 11
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10], [Table 11], [Table 12], [Table 13], [Table 14], [Table 15], [Table 16], [Table 17], [Table 18], [Table 19]



 

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