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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 16  |  Issue : 4  |  Page : 280-292

Vatari guggulu and mahaushadhi kwatha in amavata (Rheumatoid Arthritis): An open-label, single-arm clinical study


1 Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India
2 Department of Samhita and Siddhanta, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India

Date of Submission05-Jun-2021
Date of Decision27-Jan-2022
Date of Acceptance22-Jul-2022
Date of Web Publication17-Dec-2022

Correspondence Address:
Vibhu Powar
Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan - 573 201, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/joa.joa_157_21

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  Abstract 


Introduction: Amavata (rheumatoid arthritis [RA]) is a painful disease which is caused due to vitiated vata and Ama. Amavata has been correlated to RA in modern medical parlance. The prevalence of RA in adults of the developed world is around 0.5%–1%, amid which around 40% are registered disabled within 3 years, while around 80% are moderate to severely disabled within 20 years. Based on the pathogenesis of Amavata, the treatment shall be focused mainly on ama-pachana (digestive) and agni dipana (carminative). Most of the ingredients in vatari guggulu and mahaushadhi kwatha are katu (pungent), tikta (bitter) rasa (taste), and ushna virya (hot potency), which helps in ama pachana (digestive) and agni dipana (carminative) action. Ingredients namely gandhaka (Sulphur), guggulu (Commiphora mukul), haritaki (Terminalia chebula), and amalaki (Emblica officinalis) are having rasayana property; while shunti (Zingiber officinale), guduchi (Tinospora cordifolia), guggulu, haritaki, vibhitaki (Terminalia bellerica), and amalaki have anti-inflammatory property. Methods: Thirty patients were administered vatari guggulu 1 tablet (1 g) along with mahaushadhi kwatha 15 ml thrice daily after food with warm water as anupana (adjuvant) for 15 days. Ordinal data were analyzed with Friedman's test followed by Wilcoxon sign rank test as post hoc; continuous data were analyzed with repeated measures ANOVA after applying Bonferroni correction with paired t-test as post hoc. Results: There was statistically significant improvement in the primary outcome measures, in disease activity and functional ability indices. Conclusion: Vatari guggulu and mahaushadhi kwatha are effective in the management of Amavata.

Keywords: American College of Rheumatology-European League Against Rheumatism, amavata, ayurveda, mahaushadhi kwatha, routine assessment of patient index data 3, rheumatoid arthritis, simplified disease activity index, vatari guggulu


How to cite this article:
Powar V, Jayaprakash GK, Jadhav LL, Sreedevi K S, Bhatt R. Vatari guggulu and mahaushadhi kwatha in amavata (Rheumatoid Arthritis): An open-label, single-arm clinical study. J Ayurveda 2022;16:280-92

How to cite this URL:
Powar V, Jayaprakash GK, Jadhav LL, Sreedevi K S, Bhatt R. Vatari guggulu and mahaushadhi kwatha in amavata (Rheumatoid Arthritis): An open-label, single-arm clinical study. J Ayurveda [serial online] 2022 [cited 2023 Feb 6];16:280-92. Available from: http://www.journayu.in/text.asp?2022/16/4/280/364040




  Introduction Top


Amavata (rheumatoid arthritis [RA]) is a painful disease which is caused due to vitiated vata and Ama. It has been correlated to RA in modern medical parlance. Amavata is a condition in which there is the formation of ama due to manda agni, which circulates all over the sharira along with prakupita vata dosha, and takes sthana-samshraya (localization) in the sandhi (joint) causing shotha (swelling), shoola (pain), sthabdata (stiffness), along with aruchi (anorexia), angamarda (myalgia), trishna (increased thirst), alasya (laziness), gaurava (heaviness), and jwara (fever). The treatment principle includes langhana, ruksha-swedana, tikta-katu dipana, virechana, snehapana, basti, and upanaha.[1]

The prevalence of RA in adults of developed world is around 0.5%–1%, amid which around 40% are registered disabled within 3 years, while around 80% are moderately to severely disabled within 20 years.[2] It surges between the age group of 25 and 55 years after which it plateaus until the age of 75 years.[3] RA is a symmetrical, destructive, and deforming polyarthritis affecting small and large synovial joints with associated systemic disturbance.[4] The typical clinical features include swelling of the joints, pain, morning stiffness, systemic symptoms such as fever, malaise, fatigue, and weight loss. As the disease advances, joint destruction occurs resulting in limitation of motion, instability, subluxation, and deformities.[5] The general line of treatment includes physical rest, nonsteroidal anti-inflammatory drug therapy, intra-articular corticosteroid injections, disease-modifying antirheumatic drugs (DMARD), and surgical treatment.[6] Among these, DMARDs are the first line of treatment in RA which acts by interfering with critical pathways in the inflammatory cascade along with immunosuppression and immunomodulation. The wide degree of adverse effects of DMARD such as anemia, leukopenia, myopathy, cardiomyopathy, bone marrow suppression, hepatotoxicity, interstitial lung disease, liver cirrhosis, hypertension, increased risk of common and serious infections (bacterial, fungal, and viral), reactivation of tuberculosis, herpes zoster, and hepatitis B/C is a serious limitation for its long-term use. The combination of vatari guggulu and mahaushadhi kwatha will help overcome the above limitations as both the formulations have no documented adverse effects and is said to be clinically safe.

Vatari guggulu comprises eranda taila, shuddha gandhaka, shuddha guggulu, haritaki, vibhitaki and amalaki in equal proportions;[7] mahaushadhi kwatha consists of guduchi and shunti in equal quantities.[8] Most of the drugs from the above formulations are of katu-tikta rasa, ushna veerya, and madhura-katu vipaka. It has properties like ama pachana, dipaniya, shola hara, vata-kapha hara. Drugs such as amalaki, haritaki, gandhaka, guggulu have rasayana properties as well.[9],[10],[11],[12] Shunti and amalaki have a proven antioxidant property,[13] Experimentally, guduchi has exhibited anti-arthritic and anti-inflammatory properties.[14] Hence to clinically evaluate the combined effectiveness of vatari guggulu and mahaushadhi kwatha in the management of Amavata (RA) this study was conducted.


  Methodology Top


Source of data

Patients attending the outpatient department of Kayachikitsa, Shri Dharmasthala Manjunateshwara (SDM) College of Ayurveda and Hospital, Hassan.

Method of collection of data

Screening

A screening form was prepared with all aspects of history, signs, and symptoms of Amavata (RA) and laboratory investigations were conducted to arrive at proper diagnosis and to rule out major illness.

Diagnostic criteria

Among screened patients, amavata was diagnosed on the basis of amavata lakshana-angamarda, aruchi, trishna, alasya, gaurava, jwara, aapaka, shotha, shola, and stabdhata of sandhi (joints) as well as 2010 American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) classification criteria for RA was taken into consideration.[15]

Inclusion criteria

Amavata with features of RA as specified in 2010 ACR-EULAR classification criteria for RA with <5 years of chronicity, aged between 20 and 60 years, either gender and patient willing to participate in the study and ready to sign informed consent form were included for the study (parameters in ACR-EULAR criteria: duration of symptoms, joint distribution, serology, acute phase reactants).

Exclusion criteria

Patients who are known case of hypertension, diabetes mellitus, impaired renal, hepatic, and cardiac function, other systemic disorders, systemic arthritis (gout, tubercular arthritis, systemic lupus erythematosus, and psoriatic arthritis), swan neck deformity, boutonniere deformity, and rheumatic nodules were excluded from the study.

Ethical clearance and clinical trials registry- India registration

Ethics clearance certificate obtained from Institutional Ethics Committee.

The trial was registered on www.ctri.gov.in (CTRI NO: CTRI/2018/05/014035 dated May 22nd, 2018).

Study design

The study was an open-label, single-arm, prospective clinical trial in Amavata (RA) (n = 30) selected using the convenience (nonrandom) sampling technique with pre- and post-design conducted in tertiary Ayurveda hospital attached to Ayurveda medical college located in district headquarters in southern India.

Intervention

  1. Medicine-1: -Vatari guggulu[7]


    • Dosage -1 tablet (1 gm) thrice daily after food.
    • Duration -15 days
    • Anupana -Ushnodaka (warm water).


  2. Medicine-2: -Mahaushadhi kwatha[8]


  • Dosage -15 ml thrice daily after food
  • Duration -15 days
  • Anupana -Ushnodaka.


Follow-up during treatment: Starting from the day of treatment, follow-up was done on the 7th day and 15th day.

Source of raw drug

Raw materials for vatari guggulu and mahaushadhi kwatha were purchased and authenticated from good manufacturing practices (GMP) certified pharmacy.

Method of preparation

Vatari guggulu and mahaushadhi kwatha were prepared in Teaching pharmacy, Department of Rasashastra and Bhaisajya Kalpana, SDM College of Ayurveda, Hassan.

Vatari guggulu

Method of preparation

Guggulu shodhana: 1 kg of guggulu was taken and added in 8 L of dashamoola kashaya and boiled on madhyama agni (medium fire) till guggulu was melted. It was then filtered and squeezed with kora cloth to remove impurities and was dried in sunlight, the obtained shuddha (purified) guggulu was stored in an air-tight container.

Gandhaka shodhana: 1 kg gandhaka was taken and heated on madhyama agni in an iron vessel, melted gandhaka was filtered with kora cloth into cow milk. Later it was washed with lukewarm water and dried in shade. This process was repeated for 7 times and obtained shodhita (purified) gandhaka was stored in air-tight container.

Shuddha (purified) guggulu was taken in a vessel and melted at madhyama agni, fine powder of haritaki, vibhitaki, amalaka, shuddha gandhaka, and eranda taila-½kg each were added and mixed well. Tablets of 1 g each were prepared and stored in a plastic air-tight container of 23 tablets each and labeled as per GMP standard.

Mahaushadhi kwatha: Coarse powder of shunti and guduchi 14 kg each were taken, boiled with 8 parts of water, and reduced to 1/4th. The prepared kashaya was properly packed in bottles of 100 and 200 ml, labeled and stored as per GMP standard.

Reporting of adverse drug reaction

Adverse drug reaction (ADR) was recorded as per the National Ayurveda protocol for ADR.

Primary outcome measures

Signs and symptoms of amavata namely avipaka, aruchi, trishna, alasya, gaurava, jwara, angamarda, nidra viparyaya, sandhi ruja, sandhi shotha, sandhi sparshasahyata, sandhi ushnata, sandhi stabdhata were assessed using a self-graded scale at three intervals, namely before treatment, 7th day and 15th day.

Secondary outcome measures

Disease activity

Disease activity score 28 (DAS28),[16] routine assessment of patient index data (RAPID3),[17] ACR EULAR,[15] and simple disease activity index- (SDAI)[18] score.

Functional activity assessment

Grip strength (In mm of Hg) and Foot pressure (In Kg) These criteria were assessed at three intervals, namely before treatment, 7th day and 15th day, respectively.


  Observations and Results Top


Results of primary and secondary outcome measures along with important observations based on demographic profile, baseline lakshana, and laboratory parameters are enlisted in [Table 1], [Table 2], [Table 3], [Table 4].
Table 1: Baseline details of 42 patients of amavata

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Table 2: Effect of therapy on lakshana (signs and symptoms) of Amavata (rheumatoid arthritis) between three intervals of treatment (n=30)

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Table 3: Effect of therapy on Sandhi lakshana between three intervals of treatment

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Table 4: Effect of therapy on secondary outcome measures

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Timeline of improvement in signs and symptoms during therapy

  1. Therapy showed improvement in primary outcome measures such as avipaka, aruchi, alasya, gaurava, jwara, sandhi ruja, sparshasahyata, sandhi stabdhata and sandhi ushnata. It showed improvement in secondary outcome measures such as RAPID3, ACR-EULAR, SDAI, and DAS28 score
  2. Ama lakshana such as avipaka and aruchi took 15 days to show significant improvement in 100% and 75% of patients, respectively, while lakshana such as gaurava, angamarda, and alasya showed improvement in the 1st week of therapy in 58.3%, 44%, and 37% patients respectively. In nidra viparyaya improvement was seen in 2nd week of therapy in 63.6% of patients
  3. Major (upper and lower limbs) and minor joints (upper limb) showed significant improvement in sandhi ruja in the 1st week of therapy, while minor joints of lower limbs showed improvements in the 2nd week of therapy
  4. Major joints of lower limbs showed significant improvement in shotha in 15 days, while minor joints of upper limb showed improvement in the 2nd week of therapy
  5. Major joints of upper and lower limbs showed significant improvement in sparshasahyata in the 1st week of therapy, while minor joints of upper and lower limb showed improvement in 2nd week
  6. Major joints of upper limb showed improvement in ushnata in 15 days, while major joints of lower limb showed improvement in 2nd week
  7. There was a significant improvement in RAPID3 score, foot pressure-right, grip strength (bilateral), and morning stiffness in the 1st week of therapy, while foot pressure-left showed improvement in 15 days.



  Discussion Top


Avipaka, alasya, gaurava, angamarda, aruchi, trishna, jwara are the lakshana of ama which is caused due to intake of viruddha ahara, mandaagni and nischalata. Ingredients of mahaushadhi kwatha are shunti and guduchi, which is of katu-tikta rasa, ushnavirya which helps in ama pachana and deepana. Vatari guggulu consists of drugs like haritaki, vibhitaki, guggulu, eranda, and gandhaka which has properties such as deepana, pachana, ushnavirya, and does bhedana as well as lekhana. These properties help in ama pachana and improving the agni, thereby reducing the ama lakshana. The detailed results showing the effect of therapy on ama lakshana are described in [Table 2].

Nidra viparyaya is caused due to vriddhi of vata dosha. Majority of the drugs in vatari guggulu and mahaushadhi kwatha are of ushna virya, and are vata shamaka, which helps in improving the nidra.

It can also be due to other causes such as angamarda, sandhi ruja which may be hampering the nidra of the patient. As statistically significant improvement was seen in angamarda and sandhi ruja, it would have helped in improving Nidra.

The lakshana such as ruja, shotha, sparshasahyata and ushnata are caused due to the deposition of ama along with vitiated dosha in the sandhi. Sandhi ruja and sparshasahyata are due to the vata prakopa caused by margavarodha (obstruction) by ama, while the vitiation of pitta and shleshaka kapha in the sandhi leads to sandhi ushnata and sandhi shotha respectively.

According to modern science, the symptoms such as pain, tenderness, swelling, and localized warmth are caused due to the inflammatory changes and synovitis occurring in the joint.

Ingredients of mahaushadhi kwatha are shunti and guduchi, which is of katu-tikta rasa, ushna virya which helps in ama pachana and deepana. Vatari guggulu consists of drugs such as haritaki, vibhitaki, guggulu, eranda and gandhaka which are deepana, pachana, ushna virya, and does bhedana and lekhana. These properties help in ama pachana, thereby removing the margavarodha. Ingredients namely shunti, eranda, triphala helps to pacify the vata due to its ushna virya thereby helps in pacifying sandhi ruja, while triphala, eranda, gandhaka, and guduchi helps to pacify pitta and subsides sandhi ushnata due to its madhura vipaka.

Drugs such as triphala, guggulu, guduchi, shunti consists of – chebulagic acid, guggulsterol-y, gingerols, and columbin – which help in suppressing the inflammatory mediators like tumor necrosis factor-alpha, interleukin-1β (IL-1β), IL-6,[19],[20],[21],[22] thereby reducing the inflammatory symptoms such as pain, swelling, tenderness, and localized warmth.

Sandhi stabdhata is caused due the prakopa of kapha and vata dosha. Morning stiffness may be due to an increase in inflammatory edema in the early morning, perhaps related to a diurnal variation in adrenal corticosteroid production, and due to variation in elasticity of connective tissue. Most of the drugs in the above formulation are ushna virya, and vata-kapha hara which helps pacifying vata and kapha dosha, thereby reducing the stabdhata. The detailed results showing the effect of therapy on sandhi lakshana are described in [Table 3].

The functional ability of patients was assessed using RAPID3 score, grip strength, and foot pressure. Statistically significant improvement in overall lakshana might be the reason for the improvement in the rapid 3 score.

The grip strength was assessed by the patient's ability to inflate the ordinary sphygmomanometer cuff under standard conditions. The readings were recorded in mm of Hg at three intervals namely, before treatment, 7th day and after treatment.

Foot pressure was assessed by the patient's ability to apply pressure with one foot at a time on the weighing machine in sitting position. The readings were recorded in kilogram (kg) at three intervals namely, before treatment, 7th day, and after treatment.

Grip strength and foot pressure are reduced due to ruja, shotha, and stabdhata in sandhi, which hampers the joint movement and muscular strength. Statistically significant improvement in the above parameters helped in improving grip strength and foot pressure. The detailed results showing the effect of therapy on functional ability are described in [Table 4].

The disease activity of patients was assessed using DAS28, SDAI, ACR-EULAR scores. The above scores are calculated based on the total tender joints, swollen joints, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels. The effect of the drugs on shotha, sparshasahyata, sandhi ruja as discussed above are significant, hence there was a significant improvement in all the above parameters.

ESR and CRP are general inflammatory markers which may be correlated to the level of ama in the body. The detailed results showing the effect of therapy on disease activity are described in [Table 4].

Strength and limitations of the study

Strengths

  • Significant improvement was observed in primary and secondary outcome measure in a short study duration of 15 days
  • No adverse drug reactions were noted during the study.


Limitations

  • The number of dropouts was more due to the acute exacerbations of the disease
  • Small sample size.



  Conclusion Top


Vatari guggulu and mahaushadhi kwatha (orally) are beneficial in the management of amavata (RA). No ADR was recorded during the study; both the formulations seem to be clinically safe.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.





 
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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