E-ISSN:2456-3110

Research Article

Amavata

Journal of Ayurveda and Integrated Medical Sciences

2022 Volume 7 Number 10 November
Publisherwww.maharshicharaka.in

A randomised comparative clinical study to assess the efficacy of Lavangadi Churna over Ajamodadya Churna in the management of Amavata

Sharanagouda.1*, M. Kadlimatti S.2
DOI: http://dx.doi.org/10.21760/jaims.7.10.10

1* Sharanagouda, Post Graduate Scholar, Department of P.G. Studies in Kayachikitsa, BLDEA’s AVS Ayurveda Mahavidyalaya, Vijayapura, Karnataka, India.

2 Sanjay M. Kadlimatti, Professor and Principal, Department of P.G. Studies in Kayachikitsa, BLDEA’s AVS Ayurveda Mahavidyalaya, Vijayapura, Karnataka, India.

Background: Amavata is a disease, where involvement of Ama and Vata can be seen. Here formation of Ama and vitiation of Vata take place simultaneously by their respective causative factors. Acharya Madhavakara has described the Amavata first. This Amavata can be compared with Rheumatoid arthritis showing similarities in clinical features. Objective:  To assess the effect of Lavangadi churna over Ajamodadya Churna in the management of Amavata. Materials and Methods: The sample size of the study consists of 40 patients of Amavata. and either sex of age group 20-60years. Patients were randomly selected and grouped into 2 groups namely Group A & Group B. Group A were given Lavangadi churna and Group B were given Ajamodadya Churna. The dosage of both the drug is 3gms twice in a day after food with lukewarm water. Follow up was fixed every 15th day i.e., 1st follow up on 15th day, 2nd follow up on 30th day, after treatment follow up on 45th day and duration of treatment was fixed 1 month. Patients were advised to follow Pathyapathya throughout the study. A special proforma was made to record the observation based on subjective and objective parameters. Results and Conclusion: Overall effect of the trial drug showed good response in both subjective parameters & objective parameters and Overall effect of the control drug showed good response in some parameters like Heaviness, Anorexia, Thirst, Fever. Hence trial dug supported research hypothesis. Intervention was cost effective, adaptable, and safe.

Keywords: Amavata, Ajamodadya Churna, Lavangadi Churna, Rheumatoid Arthritis, Stiffness

Corresponding Author How to Cite this Article To Browse
Sharanagouda, Post Graduate Scholar, Department of P.G. Studies in Kayachikitsa, BLDEA’s AVS Ayurveda Mahavidyalaya, Vijayapura, Karnataka, India.
Email:
Sharanagouda, Sanjay M. Kadlimatti, A randomised comparative clinical study to assess the efficacy of Lavangadi Churna over Ajamodadya Churna in the management of Amavata. J Ayu Int Med Sci. 2022;7(10):77-85.
Available From
https://www.jaims.in/jaims/article/view/2121

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2022-10-01 2022-10-03 2022-10-10 2022-10-17 2022-10-23
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
Nil Nil Yes 16%

© 2022by Sharanagouda, Sanjay M. Kadlimattiand Published by Maharshi Charaka Ayurveda Organization. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License https://creativecommons.org/licenses/by/4.0/ unported [CC BY 4.0].

Introduction

Amavata is composed of two words, Ama and Vata, in which Ama is end product of incomplete digestion, due to impaired function of digestive fire. and it associates with aggravated Vata causes diseases named as Amavata. Acharya Madhavakara defined it as “Amavata is the disease where Ama and vitiated Vata along with Kapha settles in Trika Sandhi causing Stiffness, Heaviness etc. Here the vitiation of Vata and Kapha takes place simultaneously”.[1]

Acharya Madhavakara was the first person to explain Amavata as a separate disease entity. Later Acharya Chakrapani has thoroughly described the treatment principle for Amavata. Acharya Chakrapani mentioned various formulations for Amavata, which are highly useful in treatment.

Later various Acharyas have explained etiology, symptoms, pathogenesis, types, treatment principles, complications, and do’s & don’ts in detail. There is a detail explanation available regarding Amavata in various Ayurvedic literature.

He further tells, due to indulging in etiology, the vitiation of Vata and formation of Ama takes place simultaneously. Both these two factors move all over the body. and gets lodges in Kapha places & produces disease known as Amavata. and symptoms includes joint pain, stiffness, anorexia, heaviness, fever, indigestion etc.

Acharyas have described various measures like Langhana, Swedana, administration of Tikta, Deepana, Katu Dravyas, Virechana, different kinds of Basti, and numerous formulations for treatment of Amavata.

It can be corelated with Rheumatoid arthritis in modern aspect. Rheumatoid Arthritis is a chronic systemic inflammatory disorder that affects many tissues and organs including skin, blood vessels, heart, lungs and the muscles. But the disorder principally affects the joints, producing a non-suppurative proliferative synovitis that often progress to destruction of the articular cartilage and ankylosis of the affected joints.

The prevalence of RA worldwide is approximately 0.8% (0.3 to 2.1%) amongst the adult population. Whereas in India, the prevalence is 0.5% to 0.75% among adult population.

The peak age of onset of RA is in the fourth and fifth decade of life with More than 75% patients developing disease between 30 and 50 years of age. As per the gender wise incidence, RA occurs more commonly in females than in males, with a ratio of 3:1.[2-4] In modern medicine still researches are going on regarding, to find out exact etiology, pathogenesis, and treatment aspect. In modern medicine it is treated with NSAID’s, Steroids, DMRAD’s, and Immunosuppressants.

Ayurvedic literature describes many drugs in different formulations for treatment of Amavata. The drugs having the properties of Amapachana, Deepana, Vatakaphahara, Lekhana, Shothahra, Srotoshodhana, results in relieve from joint pain, swelling, stiffness, anorexia, fever and enhances digestive fire which helps in Pachana of Ama. For the treatment of Amavata, Drugs having the above-mentioned properties are must. So we have selected Lavangadi Churna and Ajamodadya Churna as described in Bhaishajya Ratnavali and Sharangadhara Samhita Madhyama Khanda respectively.[5,6] entitled it as “A randomised comparative clinical study to assess the efficacy of Lavangadi Churna over Ajamodadya Churna in the management of Amavata.” In this clinical trial, an attempt has been made to analyse the efficacy of Lavangadi Churna over Ajamodadya Churna by selecting 40 patients randomly and divided into two groups each containing 20 patients. For this clinical study Group A was assigned with Lavangadi Churna and Group B was assigned with Ajamodadya Churna.

Materials and Methods

Pharmaceutical Source: All the materials were collected from genuine local market. They are authenticated by the Dept. of Dravyaguna, BLDEA’S AVS Ayurveda Mahavidyalaya, Vijayapur. The formulations prepared as per the classical reference, in the BLDEA’S AVS Ayurveda Pharmacy attached to the Dept of Rasashastra and Bhaishajya Kalpana for the study.

Sample Source: A total of 44 patients were registered, with four being dropped out from the study, and total 40 being included in the research from the Dept of Kayachikitsa, BLDEA’s AVS Ayurveda Mahavidyalaya Hospital and Research Centre. Patients were selected randomly divided in two groups Group A and Group B, each group contains 20 patients.


The Group A patients given with Lavangadi Churna and Group B patients given with Ajamodadya Churna. The parameters were noted before, during and after treatment, the results are observed with suitable statistical methods and further elaborated in this study.

Inclusion Criteria
a. Patients presenting with the classical signs and symptoms of Amavata.

b. Patients of either sex aged between 20 - 60 years.

c. Patients willing and able to participate in the study.

Exclusion Criteria
a. Patients who are not willing for clinical study.

b. Patients suffering from acute systemic disorders as well as other known case if major illness like any type of Cancer, HIV, Gouty Arthritis, Syphilis, Tuberculosis, Gonococcal Infections etc.

c. Pregnant or Lactating Ladies.

Withdrawal Criteria: If the patient selected for this study, If patient not followed instructions properly, Then patient has considered as Dropout. If the symptoms of patient aggravated and will need any Emergency Medicine for relief, such patients has been dropped out from the study.

Investigations

  • CBC
  • ESR (Erythrocytes Sedimentation Rate)
  • RA Test
  • Radiological X-Ray of affected joints, if necessary
  • CRP Test, if necessary.

Study Design: 40 patients with Amavata has been taken for the study and randomly divided into 2 groups consisting of 20 patients in each group.

Group A
Sample Size: 20 Patients.

Formulation: Lavangadi Churna

Dosage: 3gm twice in a day.

Time of medicine intake: Post prandial medicine intake

Vehicle: Lukewarm water

Duration: 30 Days

Follow-Up: On every 15th day.

Group B
Sample Size: 20 Patients.

Formulation: Ajamodadya Churna.

Time of medicine intake: Post prandial medicine intake

Vehicle: Lukewarm water

Duration: 30 Days

Follow-Up: On every 15th day.

Parameter for Assessment: Assessment has been done based on subjective and objective parameters. Before, during,

After the scheduled treatment with an interval of 15 days.

A. Subjective Parameters
1. Pain

2. Stiffness

3. Indigestion

4. Heaviness

5. Anorexia

6. Thirst

7. Sleep disturbance

B. Objective Parameters
1. Swelling

2. Fever

3. Loss of function

4. Grip Strength

5. Foot Pressure

6. Range of Movement

7. Functional Ability

Score Assessment Pattern
Subjective Parameters

1. Pain: Score

  • No Pain : 0
  • Mild (Does not interfere with most activities. Able to adopt to pain psychologically with medications or devices such as cushions) : 1

  • Moderate (Interferes with many activities, requires lifestyle changes but patient remains independent. Unable to adopt pain) : 2
  • Severe (Unable to engage in normal activities. Patient is disabled and unable to function independently) : 3

2. Stiffness: Score

  • No stiffness : 0
  • Stiffness for 30 Min – 1 Hr : 1
  • Stiffness for 1 Hr – 2Hr : 2
  • Stiffness More than 2 Hr : 3
  • Stiffness More than 2 Hr : 4

3. Indigestion: Score

  • No indigestion : 0
  • Heavy foods not digested properly : 1
  • Delayed digestion of lighter foods : 2
  • Impaired digestion of even lighter foods : 3

4. Heaviness: Score

  • No feeling of heaviness : 0
  • Occasional heaviness in body does usual work : 1
  • Continuous heaviness in body but does usual work : 2
  • Continuous heaviness which hampers the usual work : 3
  • Unable to do any work due to heaviness : 4

5. Anorexia: Score

  • Normal desire for food : 0
  • Eating timely without much desire : 1
  • Desire for food, little late, then normal time : 2
  • Desire for food only after long intervals : 3
  • No desire at all : 4

6. Thirst: Score

  • Quantity of water intake 0-2 litres per day : 0
  • Quantity of water intake > 2-3 litres per day : 1
  • Quantity of water intake > 3-4 litres per day : 2
  • Quantity of water intake > 4 litres per day : 3

7. Sleep disturbance: Score

  • Sound sleep (6-8 Hr / Day) : 0
  • Irregular sleep (6 – 7 Hr / Day) : 1
  • Disturbed sleep due to pain (4 – 5 Hr / Day) : 2
  • No sleep due to pain (< 4 Hr / Day) : 3

Objective Parameters

1. Swelling: Score

  • No Swelling : 0
  • Mild Swelling : 1
  • Moderate Swelling : 2
  • Severe Swelling : 3

2. Fever: Score

  • Absence of fever : 0
  • Fever symptom, without rise in temperature : 1
  • Fever symptom, Temperature up to 100°F : 2
  • Fever symptom, Temperature > 101°F : 3

3. Loss of function: Score

  • Can perform personal daily work : 0
  • Mild pain while doing daily personal work : 1
  • Need others help : 2
  • Dependent on others : 3

4. Grip Strength: Score

The patient’s ability to compress the inflated ordinary sphygmomanometer cuff under standard conditions to assess the functional capacity of effected upper limb, both before, during and after treatment.

Grading is done as follows:

  • 200 mm Hg or more : 0
  • 200 to 120 mm Hg : 1
  • 120 to 70 mm Hg : 2
  • Under 70 mm Hg : 3

5. Foot Pressure: Score

Foot pressure was recorded before, during and after treatment by the ability of the patient to press a weighing machine, to an objective view of functional capacity of lower limb.

Grading is as follows:

  • 25 to 21 kg : 0
  • 20 to 16 kg : 1
  • 15 to 10kg : 2
  • Less than 10 kg : 3



6. Range of Movement: Score

Measurement of range of joint movement using Goniometer before, during and after treatment.

Grading is as follows:

  • 100° to 130° : 0
  • 70° to 99° : 1
  • 30° to 69° : 2
  • 0 to 29° : 3

7. Functional Ability: Score

  • Without any difficulty : 0
  • With some difficulty : 1
  • With much difficulty : 2
  • Unable to do : 3

Statistical Analysis: The obtained data was analyzed statistically with Chi square test, Friedman test, Mann Whitney U test and Wilcoxon signed rank test.

Overall Assessment

  • Good Response - If the overall improvement is >75%
  • Moderate Response - If the overall improvement is greater than or equal to 50% but <75%
  • Poor Response - If the overall improvement is less than 50%

Observations

The observations of the present study in the age category reveals that 50% of patients age group is between 30 to 50years, 35% of patients age group is above 50years. In Group A it was observed that, 45% patients’ occupation was house work, 25% patients’ occupation was office work. In Group B, 40% patients’ occupation was house work, both field work and office work contains 25% patients. It was observed in this study, majority of the patients in Group A and Group B belongs to Madhyama Koshta i.e., 70% & 75% respectively.70% of the patients in Group A have chronicity of < 1year, and while in Group B 60% of the patients have chronicity of < 1 year. Both in Group A and Group B 45% patients’ onset were gradual. 55% & 50% patients’ onset were sudden in Group A and Group B respectively. In Group A 55% patients were belonged to Vata-Pitta Prakruti and In Group B 60% patients belonged to Vata-Pitta Prakruti.

85% patients in Group A and 95% patients in group B were having Madhyama Sara. Majority of the patients in Group A & Group B were having Madhyama Samhanana i.e., 80% and 70% respectively. 95% & 75% patients in Group A and Group B were having Madhyama Pramana. In Group A, 50% & in Group B, 80% patients were having Madhyama Satmya. In Group A, 65% & in Group B patients were having Madhyama Satwa. In Group A, 70% & in Group B 80% patients were having Madhyama Ahara Shakti. In Group A 65% & in Group B 40% patients were having Madhyama Vyayama Shakti.

Majority of the patients in both the groups were having pain, Anorexia, indigestion, heaviness. Majority of the patients in Group A & Group B were not having thirst i.e., 80% & 70% respectively. In Group A 60% & in Group B 40% patients were having sleep disturbance. 65% patients in both the groups were having Swelling and fever. 80% patients in both the groups were having loss of function and deterioration of functional ability. 60% patients were not having reduced grip strength and foot pressure.

Results

Table 1: Effect of Lavangadi Churna on Group A.

Parameters Before Treatment After treatment follow up Mean Diff In % Wilcoxon signed rank test P value
Mean SD Mean SD
Pain 1.45 0.510 0.00 0.000 1.45 100% 4.041 0.0001*
Stiffness 1.45 0.605 0.05 0.224 1.4 97% 4.053 0.0001*
Indigestion 1.05 0.686 0.00 0.000 1.05 100% 3.666 0.0001*
Heaviness 0.85 0.587 0.00 0.000 0.85 100% 3.690 0.0001*
Anorexia 1.15 0.489 0.00 0.000 1.15 100% 4.300 0.0001*
Thirst 0.20 0.410 0.00 0.000 0.20 100% 2.000 0.046*
Sleep Disturbance 0.65 0.587 0.00 0.000 0.65 100% 3.357 0.01*
Swelling 0.75 0.639 0.00 0.000 0.75 100% 3.419 0.01*
Fever 0.55 0.759 0.00 0.000 0.55 100% 3.419 0.01*
Loss of Function 0.85 0.366 0.05 0.224 0.8 94% 2.598 0.009*
Grip-Strength 0.45 0.510 0.00 0.000 0.45 100% 4.000 0.0001*
Foot- Pressure 0.25 0.444 0.00 0.000 0.25 100% 3.000 0.003*
Range of Movement 0.30 0.470 0.00 0.000 0.30 100% 2.236 0.025*
Functional Ability 0.85 0.366 0.00 0.000 0.85 100% 2.449 0.014*

*: Statistically highly significant


jaims_2121_01.JPG

Graph 1: Showing effect of Lavangadi Churna on group A.

Table 2: Effect of Ajamodadya Churna on Group B.

Parameters Before treatment After treatment fallow up Mean Diff In % Wilcoxon signed ranks test P value
Mean SD Mean SD
Pain 1.45 0.510 0.60 0.681 0.85 59% 3.690 0.0001*
Stiffness 1.45 0.605 0.70 0.865 0.75 52% 3.095 0.002*
Indigestion 1.05 0.759 0.15 0489 0.9 86% 3.819 0.0001*
Heaviness 0.90 0.553 0.25 0.550 0.65 72% 3.606 0.0001*
Anorexia 0.90 0.641 0.15 0.489 0.75 83% 3.873 0.0001*
Thirst 0.35 0.587 0.05 0.224 0.3 86% 2.449 0.014*
Sleep Disturbance 0.50 0.688 0.20 0.410 0.3 60% 2.121 0.034*
Swelling 0.65 0.587 0.30 0.470 0.35 54% 2.646 0.008*
Fever 0.50 0.761 0.00 .000 0.50 100% 2.428 0.015*
Loss of Function 0.95 0.224 0.45 0.510 0.44 46% 3.162 0.002*
Grip-Strength 0.60 0.598 0.55 0.605 0.05 8.3% 1.000 0.317
Foot- Pressure 0.35 0.489 0.30 0.470 0.05 14% 1.000 0.317
Range of Movement 0.35 0.489 0.30 0.470 0.05 14% 1.000 0.317
Functional Ability 0.95 0.224 0.45 0.510 0.5 53% 3.162 0.002*

*: Statistically highly significant

jaims_2121_02.JPG

Graph 2: Effect of Ajamodadya Churna on Group B.



Table 3: Overall result of all parameters in Group A.

Parameters BT ATFU Mean Diff In % Wilcoxon signed rank test P value
Mean SD Mean SD
Total Score 10.85 3.249 0.10 0.308 10.75 99% 3.928 0.0001*

*: Statistically highly significant

Table 4: Overall result of all parameters in Group B.

Parameters BT ATFU Mean Diff In % Wilcoxon signed ranks test P value
Mean SD Mean SD
Total Score 11.00 4.713 4.35 5.194 6.65 60% 3.924 0.0001*

*: Statistically highly significant

Table 5: Comparison of overall result of all parameters between Lavangadi Churna and Ajamodadya Churna.

Parameters Lavangadi Churna Ajamodadya Churna Mean Diff In % Mann Whitney U Test P value
Mean SD Mean SD
Total Score 0.1000 0.308 4.35 5.194 4.25 98% 67.00 0.0001*

*: Statistically highly significant

jaims_2121_03.JPGGraph 3: Showing overall score.

Discussion

Pain usually seen in Amavata due to aggravation of Vata, usually aggravation of Vata occurs either due to obstruction and depletion of dhatus.[7] In this present context Vata vitiation is due to obstruction of Vata by Ama. The majority of the drugs in this trial drugs are having properties of Katurasa, Ushna Virya, Katu Vipaka and Vata Kaphahara. Hence the trial does the Deepana and Ama Pachana, this in turn destroys the obstruction of channels caused by Ama. Once this process occurs in the body Vata will have normal movement.


Present study of trial drug reveals that by doing Agni Deepana and Ama Pachana it will yield good response in subjective criterion like Pain.

Stiffness in Amavata is mainly due to presence of Ama & involvement of vitiated Kapha Vata Doshas. The drugs in this formulation contains Katu Rasa, Ushna Virya, Katu Vipaka are Danti, Yavani, Lavanga, Vacha, Chavya, Chitraka, Ajamoda. And these drugs are having functions like Deepana, Pachana, Vata-Kaphahara. By these properties they do Ama Pachana, Agni Deepana and controls the involved vitiated Vata Kapha Doshas. Coldness property of vitiated Vata Kapha Doshas and unctuousness of Ama are alleviated by sharp, hot, dry properties of trial drug. Hence the trail drug shown good response in alleviating the stiffness.

The indigestion occurs due to Ama or vice versa. Indigestion is important symptom of Ama. The ingredients of the trial drugs contain Katu Rasa, Ushna Virya, Katu Vipaka are Danti, Yavani, Lavanga, Vacha, Chavya, Chitraka, Ajamoda. The Katu Rasa consider to be Deepaniya, and majority of the drugs having Deepana as a main function. By virtue of above said properties the trial drug efficiently acts on indigestion.

Heaviness and anorexia usually seen in Amavata due to presence of Ama and involvement of vitiated Kapha. The trial drug is having properties like Deepana, Ama Pachana, Kaphahara. Hence by alleviating the Ama & normalizing vitiated Kapha, it reduces the heaviness and anorexia.

Acharya Charaka told various types of thirst in Chikitsasthana 22nd chapter namely Vataja, Pittaja, Amaja, Kshayaja, Upsargaja Trishna.[8] In this context we should consider Amaja Trishna. The trial drug does elimination of Ama by virtue of Deepana, Ama Pachana properties significantly reduces the thirst.

The sleep disturbance usually seen in Amavata either may be due to involvement of vitiated Vata or due to presence of pain, stiffness, etc. and also due to presence of Kapha, patients used to sleep more at day time that leads to sleep disturbance at night time. This trial drug having property Vatahara, Ama pachana & it reduces the symptoms like pain, stiffness etc. by above said properties. Thus, the trial drug significantly effective in alleviating the sleep disturbance.

Acharya Charaka explained in Chikitsasthana 12th chapter, the vitiated Kapha, Rakta, & Pitta enter into the external channels and does the obstruction that leads to Vata vitiation. This causes the manifestation of swelling.[9] The trail drug Lavangadi Churna being Vata Kaphahara property removes the obstruction. and the trial drug contains Gokshura as one of the ingredients, Gokshura is having anti-inflammatory action. So, virtue of these properties it significantly pacifies the swelling.

Fever in Amavata is due to dislodgement of digestive fire from its normal place. In this context Ama does obstruction to the doshas leading to displacement of digestive fire results in fever. This trial drug by virtue of Deepana, Amapachana does the elimination of Ama and alleviates fever.

Grip strength is the combined effort of joints like DIP, mcp, wrist and muscular strength and Foot pressure is the combined effort of joints of foot, leg and muscular strength. The trial drug significantly reduces the symptoms like joint pain, stiffness, swelling. This results in significant action on improving the grip strength and foot pressure.

Range of movement of joints and functional ability diminishes due to presence of swelling stiffness, pain in the joints. Efficacy of trial drug pain, stiffness, swelling results in improvement of range of movement of joints and functional ability.

Conclusion

Ama, vitiated Vata and decreased digestive fire plays very important role in manifestation of Amavata. The etiological factors explained in ancient literature for Amavata, were found to cause Amavata in patients of present study also. The trial drug Lavangadi Churna showed good response both in subjective and objective parameters which are statistically significant. The control drug Ajamodadya Churna showed good response in some parameters like heaviness, anorexia, thirst, fever and showed moderate response in some parameters like pain, swelling, stiffness, sleep disturbance & in functional ability. Showed poor response in some parameters like Grip strength, Foot pressure, Functional ability. After completion of the intervention, the trial drug supported Research Hypothesis i.e., Lavangadi Churna may have better results than Ajamodadya Churna in Amavata. The trial drug is most effective


in Samavastha of the disease with Vata and Kapha predominance and should be used vigilantly in case of predominance of Pitta Dosha. The formulation is cheap, cost effective in the management of Amavata.

Reference

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9. Maharshi Agnivesa, Acharya Charaka, Drudabala, Charaka Samhita chikitsa sthana, with Ayurveda Dipika commentary, by Laxmidhar Dwivedi, editor & commentator Dr. B.K Dwivedi, Chowkhamba Krishnadas Academy Varanasi 2013 chapter no 12, shloka no 8