Clinical Evaluation of ‘Punarnava Amrita Guggulu’ in the Management of Vata-Rakta (Gout)

Abstract

An unusual metabolic condition is Vata-Rakta. The chronic relapsing and intermittent nature of Vata-Rakta illness makes it extremely distressing. The overall prevalence of hyperuricemia is 25.8%, with a larger percentage of men than women having increased serum uric acid. Vatarakta is the name for the illness that is characterised by Raktadhatu aberration brought on by Vata Dosha morbidity. At the current study, Punarnava Amrita Guggulu was taken twice daily with lukewarm water in doses of 1gm (two 500mg tablets each). Results revealed that Vidaha (Burning sensation) (58.33%), Sandhi Shoola (reduced by 65.71%), Sandhi Shotha (reduced by 54.76%) were all statistically very significant outcomes of the current study. Raga (Redness in joints) (60.71%), Toda (Pricking sensation) (57.95%) and Twakvaivarnya (Discoloration) (61.25%). Sparsha Asahyata (Tenderness in joints) (52.47%) Visphota(58.60%) Sandhi Akunchana Prasarana Vedna(63.49%) Sandhi Vikriti (Deformity Status) (47.14%).

Introduction

I. INTRODUCTION

Despite significant progress in modern science, there are still several diseases that plague humans. The chronic relapsing and intermittent nature of Vata-Rakta illness makes it extremely distressing. Vata-Rakta is a special metabolic condition, and Vatavyadhi is one of them. One of the effects of these changes is the occurrence of Vatarakta. This Vatarakta can be related to modern medicine's Gouty Arthritis based on the indications and symptoms. One of the effects of these changes is the occurrence of Vatarakta. This Vatarakta can be related to modern medicine's Gouty Arthritis based on the indications and symptoms. One to four percent of the overall population has gout. The overall prevalence of hyperuricemia is 25.8%, with a larger percentage of men than women having increased serum uric acid. The prevalence increases to 10% in men and 6% in women in Western countries, where it occurs in 3-6% of men and 1-2% of women. Gout affects 2.68 out of every 1000 people annually1.

II. DISEASE REVIEW

Fast food and a fast lifestyle both upset the Vata. Rakta is the primary Dhusya and Vata is a dominating Dosha in Vata-Rakta at the same time as Dushita Rakta gives birth to Vata-Rakta. It is brought on by the vitiation of both Vata and Rakta. With vitiated Raktdhatu, the vitiated Vata becomes the vitiated Aavruta. The entire Rakta is tainted by Vriddhi and blocked Vata, which emerges as Vata-Rakta. Vatarakta, also known as "Vata Dushtam Raktam Yatra Roga Visheshah2," is a condition marked by aberrant Raktadhatu as a result of Vata Dosa morbidity. It mentions nidanas such as Katu, Amla, Ushna, Vidahi Aaharas, Gaja, and Ushtra Yaana. It consists of the Utthana and Gambheera stages. The main complaint of the patient is severe joint pain, which starts at Hasta Pada Mulagata Sandhi and spreads to all other joints in a manner resembling the spread of Akur visha.3 Vatarakta is thought to be one of the Maha Vyadhis where severe joint pain is a predominate symptom and disrupts the day-to-day life of the individual by immobilising the affected joints of the limbs. Sushruta Shamita describes it under Vatavyadhi Chikitsa, however Acharya Charka emphasises it in a separate chapter after Vatavyadhi Chikitsa called Vata-rakta. The type of arthritis that is best understood and described is gout. Gout is a purine metabolism condition characterised by hyperuricemia and repeated acute synovitis episodes, There is invariably hyperuricemia (6.0 mg/dl) before it. Mono-sodium urate crystallisation in joints, tendons, and surrounding tissue is a result of hyperuricemia brought on by excessive uric acid synthesis or reduced excretion. The main gout symptom that interferes with patients' daily lives is pain. Inflammatory joint disease is most prevalent in men and elderly women. 4.

III. DRUG SELECTION

Punarnava Amrita Guggulu was chosen for this inquiry, which displays in Chakradutta in Vatarakta Prakarana, because Vata and Rakta vitiation are predominant in Vatarakta. In Ayurvedic writings, these medications are referred to as having Vatashamaka, Deepana, Pachana, Vedanahara, Anulomana, and Shothhara characteristics.

A. Ingredients Punarnava Amrita Guggulu5 (Chakradutta Vaatarakta chikitsa 58/64)

Guduchi (Tinospora cordifolia) 2 Part, Rakta Punarnava (Boerhaavia diffusa), Guggulu (Commiphora mukul) Haritaki ( Terminalia chebula) Vibhitaki (Terminalia bellirica) Amlaki (Emblica officinalis) 1 part each.

Danti (Baliospermum montanum) Shunthi  (Zingiber officinale)  Chitraka  mula (Plumbago zeylanica) Pippli (Piper longum)  (Vidang  (Emblica ribes)  Guduchi  (Tinospora cordifolia) Nishoth  (Operculina trepenthum) Haritaki  (Terminalia chebula) Vibhitaki (Terminalia bellirica) was used as parkshepa dravyas in the ratio of 1/40part.

B. Method of Preparation of the Trial Drug

Above contents of Punarnava Amrita Guggulu will be taken in above explained ratio and coarse powder will be made of Guduchi, Triphala, Guggulu and Punarnava. Then 16 parts of water will be added and boil till 8 parts of water remains (i.e. Kwatha). Then after filtering it and filtered decoction will be again boiling, until it become Ghana. Then added Prakshepa Dravya in above ratio as per requirement and condensed on the medium flame. After complete mixing of all the material pills (Vati) of 500 mg each will be prepared and stored. This drug was prepared in pharmacy of DSRRAU, Jodhpur        

C. Mode of Administration

Dose of Punarnava Amrita Guggulu- 2 vati (each vati 500 mg) twice in a day with lukewarm  water for 45days.

IV. AIMS AND OBJECTIVES

1. Conceptual and Clinical Evaluation of Vata-rakta (Gout) and its management with time tested Ayuvedic principle.
2. Clinical Evaluation of Punarnava Amrita Guggulu in the management of Vata-rakta.
3. To Evaluate the Adverse Drug Reaction of the trial drug.

A. Ethical Clearance

This study was approved by Institutional Ethical Committee (IEC) DSRRAU, Jodhpur  vide letter no. Sr.No./DSRRAU/UCA/IEC/19-20/254 on dated 08/07/2020.

CTRI REGISTRATION [CTRI No. - CTRI/2021/04/033171 registered on 27/04/2021]

V. MATERIAL AND METHODS

A. Materials

1. Literary: Various literary sources of Ayurveda and modern medical science have been explored to study the subject Vatarakta or Gout respectively.
2. Clinical: This includes the observations of patients, investigations and trial  procedures.

Following material and methods will be adopted for conducting the present research project-

a. Selection of Case: The study was conducted on 40 clinically diagnosed patients of ‘Vatarakta’ (Gout) selected from OPD / IPD of UPGIAS&R, DSRRAU, Jodhpur. The case selection was random regardless of sex, age, occupation and socio-economic conditions. Patients were taken after evaluation of the clinical features of Vatarakta (Gout) for the study. A regular record of assessment of all patients was maintained according to proforma prepared for the purpose.

B. Selection Criteria

1. Inclusion Criteria

a. Patients between the age group of 20-60 years of either sex presenting with clinical features of Vata-rakta.

b. Diagnosed and confirmed case of Vata-rakta (Gout).

c. Patients having serum uric acid level more than 6 mg/dl with or without any associated features like joint pain and inflammation

d. Patients having any disorders like Diabetes mellitus, Cardiac disease etc.

2. Exclusion Criteria

a. Patients below 20 years and above 60 years will be excluded.

b. Patients suffering with other form of Arthritis like Rheumatoid arthritis, Osteoarthritis, Ankylosing spondylitis, Infective arthritis etc.

c. Pregnant and lactating mother.

d. Patients with evidence of malignancy.

3. Clinical Study

a. Study Type: Interventional, Open, Randomized, Clinical Study

b. Study Design: After the complete examination and investigation of 40 well diagnosed and confirmed patients of Vata-rakta will be administered Punarnava Amrita Guggulu in dose of 1gm (two tablets of 500mg each) twice a day with lukewarm water for 45 days.

4. Demographical Profile

In the current investigation, a total of 40 vatarakta (gout) patients were examined. They ranged in age from 20 to 60, with a maximum of 16 patients in the 41–50 age range (40%). The majority of the patients in this series were male (77.5%), Hindu (97.5%), graduate-level educated (27.5%), from a lower socioeconomic class (47.5%), working in a private employment (17.5%), addicted to tea (30%), and married (100%).

5. Clinical Profile

a. The majority of patients, according to the Dashavidha Pariksha biostatistics, had Vata-Pitta Deha Prakriti (45%), Rajasika Mansika Prakriti (52.5%), Madhyama Satva (55%) Mamsa Sara (57.5%), Madhyama Satmaya (52.5%), Madhyama Samhanana (52.5%), Avara Vyayama Shakti (62.5%), Madhyama Abhyavahara

b. The majority of patients, 36 (90%) had Rooksha, Amla, Sheetala ahara, and Kashaya Tikta ahara, while 33 patients (82.5%) had Vidahi ahara and Teekshna ahara, 23 patients (57.5%), Ratri Jagrana, Vatakara ahara, and Mithyashana, which was gained by the greatest number of patients, 34 patients (85%).

c. Among the patients, the following were the most common complaints: pain in joints, which was reported by all 40 patients (100%); swelling over joints, which was reported by 36 patients (90%); burning sensation, which was reported by 29 patients (72.5%); redness, which was reported by 28 patients (70%); pricking sensation, which was reported by 38 patients (95%); and tenderness in joints, which was reported by 39 patients (97.5%). Desquamation was present in 30 patients (75%), pain during joint movement was present in 38 patients (95%), deformity was present in 23 patients (57.5%), and analysis of the doshika involvement revealed that all patients had Vatadosha Dushti Lakshanas, with associated Pitta and Rakta dushti lakshanas in 88.88% of cases.

d. Review of Srotodusti Lakshanas reveals that 100% patients were having Raktavaha Srotodushti Lakshnas. Majjavaha (97.67%) and Asthivaha (41.86%) Sroto Dushti Lakshnas were also present

e. X-ray investigation showed that All the patients in this study were having some sort of pathological changes in ankle and toe joint as per radiological investigation. Majority of the patients of this series i.e. 50.23% were diagnosed as having Gouty changes with presence of Ostophytes.

f.  Interrogation regarding treatment history revealed that maximum number of patients had taken allopathic medication (80%).

VI. EFFECT OF THERAPY

1. In the present study Punarnava Amrita Guggulu in dose of 1gm (two tablets of 500mg each) twice a day with lukewarm water for 45 days. Results showed that  Statistically very significant results were also found in present study i.e. Sandhi Shoola was reduced by 65.71%, Sandhi Shotha (54.76%) and Vidaha (Burning sensation) (58.33%)  which were statistically extremely significant. Raga (Redness in joints) (60.71%), Toda (Pricking sensation) (57.95%) and Twakvaivarnya (Discoloration) (61.25%). Sparsha Asahyata (Tenderness in joints) (52.47%) Visphota(58.60%) Sandhi Akunchana Prasarana Vedna(63.49%)  Sandhi Vikriti (Deformity Status) (47.14%)

3. Overall symptomatically, 58.50% relief was observed in present clinical trial. So it can be say that significant / satisfactory relief was found during this research

4. In laboratory findings overall, 25.17% relief was observed during this clinical trial. So it can be say that mild relief  in objective parameters was found in during research.

VII. DISCUSSION ON RESULTS

A. The Effect Of Therapy On Subjective Parameters

1. Sandhi Shoola (Pain): In present study, the mean score before treatment was 10.500 which reduced to 3.600 after treatment, with SD±0.5071 giving a relief of 65.71%, which is statistically extremely significant (P <0.001). Sandhi shoola is mainly caused by Vata Dosha. Here Dushita Rakta does the Avarana of Vikruta Vata Dosha . Results observed from the present study shows that Punarnva Amrita Gugulu is the best remedy for Vatarakta and removes avarana and also it is the best remedy for Pitta Dosha  as well as Rakta Dhatu and as it is also Vatanulomaka.
2. Sandhi Shotha(swelling): In Present study, the mean score before treatment was 8.400 which reduced to 3.800 after treatment, with SD±0.5164 giving a relief of 54.76%, which is statistically extremely significant (P <0.001). The vitiated Vata Dosha  and Rakta Dhatu are responsible for Sandhi Shotha. Due to effect of drug Vata Dosha  is expelled out, and so it is helpful to reduce Sandhi Shotha. Virechana due to presence of Trivrutta corrects the vitiation of Pitta, hence reduces the Sandhi Shotha.
3. Vidaha (Burning sensation): In Present study, the mean score before treatment was 8.400 which reduced to 3.500 after treatment, with SD±0.4577 giving a relief of 58.33%, which is statistically extremely significant (P <0.001). The vitiated  Pitta Dosha  and Rakta Dhatu are responsible for Vidaha.  Due to effect of drug Pitta  Dosha  is expelled out, and so it is helpful to reduce Vidaha.
4. Raga (Redness in joints): In Present study, the mean score before treatment was 5.600 which reduced to 2.200 after treatment, with SD±0.6571 giving a relief of 60.71%, which is statistically extremely significant (P <0.001). The vitiated  Bhrajka Pitta and Rakta Dhatu are responsible for Raga.  Due to effect of drug Pitta  Dosha  is expelled out, and so it is helpful to reduce Raga.
5. Toda (Pricking sensation): In Present study, the mean score before treatment was 8.800 which reduced to 3.700 after treatment, with SD±0.4140 giving a relief of 57.95%, which is statistically extremely significant (P <0.001). Toda mainly occur due to vitiation of Vata Dosha . Due to effect of drug Vata  Dosha  is expelled out, and so it is helpful to reduce Toda.
6. Twakvaivarnyata (colour): In Present study, the mean score before treatment was 8.000 which reduced to 3.100 after treatment, with SD±0.5477 giving a relief of 61.25%, which is statistically very significant (P <0.001). Pitta and Rakta Dhatu are responsible for Vaivarnata. Discoloration at joint cavity occur due to inflammtion.  As Virechana, which is not only Pittta hara, Rakta prasadak, but also Rakta Shodhaka . Trial drug has significant role in Rakta Prasadana and Pitta shamana.
7. Visphota  (Desquamation status): In Present study, the mean score before treatment was 8.700 which reduced to 3.600 after treatment, with SD±0.5936 giving a relief of 58.60%, which is  statistically extremely significant (P <0.001).
8. Sparsha Asahyatva (Tenderness in joints): In Present study, the mean score before treatment was 10.100 which reduced to 4.800 after treatment, with SD±0.7037 giving a relief of 52.47%, which is statistically significant              (P =0.4915). As we know Vata is responsible for pain, “Sparsahanebyo Adhiko Vayu Sparshanam cha Tvagashrayam.”i.e. in skin vata Dosha  predominantly present. Use of Punarnva Amrita Guggulu in the present study shows significant effect on tenderness of joint.
9. Sandhi Akunchana Prasarana Vedna (Pain on joints movements): In Present study, the mean score before treatment was 6.300  which reduced to 2.300 after treatment, with SD±0.3780 giving a relief of 63.49%, which is statistically  Extremely significant (P <0.001). Pain occur during movements (due to tophi formation in the joint cavity) was significantly resolved by the use of trial drug.
10. Sandhi Vikriti (Deformity Status): In Present study, the mean score before treatment was 7.000 which reduced to 3.700 after treatment, with SD±0.7121 giving a relief of 47.14%, which is statistically significant (P =0.0311). Hyperuricemia results in deposition of uric acid crystels in the joint cavity, chronicity of the disease will gradually led to deormity of joints. Present study shows that our trial drug has significantly overcome the deformity. However prolonged use of medication will definatly results in normal joint functions.

B. The Effect Of Therapy Onobjective Parameters

1. Haemoglobin: In Present study, the mean score before treatment was 46.59 which increased to  48.63 after treatment, with SD±2.557 giving a relief of 4.38%, which is statistically not significant (P = 0.4915). Slight increase in the level of heamoglobin was probably due to effect of  raktavardhaka and piita shamaka properties of trial drug. But parameteric values are least to obtain significance of the drug.
2. TLC: In Present study, the mean score before treatment was 34039.0 which decreased to 3011.7  after treatment, with SD±1.269 giving a relief of 11.52%, which is statistically  significant (P =0.0311). Increase in TLC was due to presence of inflammation in gout. Overall effect of trial  drug had significantly lowered down the increased TLC due to anti-inflammatory effect of drug.
3. ESR: In Present study, the mean score before treatment was 256.4 which reduced to 113.4 after treatment, with SD±1.163 giving a relief of 55.77%, which is statistically Very significant (P = 0.0909). Increased ESR states inflammation in the body, while present drug lowered the ESR depicts the anti-inflammatory effect of Punarnva Amrita Guggulu.
4. Fasting Blood Sugar: In Present study, the mean score before treatment was 367.5 which reduced to 349.9 after treatment, with SD±2.079 giving a relief of 4.78%, which is  statistically not significant (P =0.0879).  Higher value of Fasting blood sugar may  led to precipitation of Gout. However, drug used in the present study had no significant action on blood sugar level.
5. Serum Uric Acid: In Present study, the mean score before treatment was 32.47 which reduced to 15.67 after treatment, with SD±1.901 giving a relief of 51.74%, which is  statistically Very significant (P =0.0041). Hyperuricemia is the chief indicator for gouty arthritis, although increased uric acid level may show asymptomatic gout. But in the present study all patients found positive in subjective symptoms too. Moreover statistical analysis of the present study proves the significant effect of study.
6. Serum Urea: In Present study, the mean score before treatment was 105.1 which reduced to 80.4 after treatment, with SD±1.604 giving a relief of 23.50%, which is    statistically not significant (P =0.0911).              
7. Radiological Abnormalities: All the patients in this study were having some sort of pathological changes in ankle and toe joint as per radiological investigation. Majority of the patients of this series i.e. 50.23% were diagnosed as having Gouty changes with presence of Ostophytes. 

Conclusion

Various Ayurvedic therapeutics of the ingredients used in the preparation of Punarnava Amrita Guggulu6 are discussed here to correlate the broad therapeutics of Punarnava Amrita Guggulu. The drug Bibhitaki, Danti and Trivritta shows Pitta-Kaphahara properties while Vidanga, Twaka and Shunthi are Vata-Kaphahara. Haritaki, Pippali, Amrita & Amalaki all are Tridosha Nashaka. Also Pitta Saraka properties of Amrita and Trivritta help to reduce Pitta and associated symptoms which can help in reducing inflammatory aspect of the disease. Most of these drugs show a characteristic of Ushna Veerya (hotpotency) with Laghu (easily digestible), Ruksha (dry) and Tikshna Guna (qualities),which helps in easy assimilation of drug in body whereas Shunthi and Guduchi are Guru (hard to digest) and Snigdha (oily) which further helps in Vatahara action of the drugs. The Vipaka (post digestive effect) characteristic of Haritaki, Bibhitaki, Amalaki, Amrita, Shunthi and Pippali are Madhura (sweet) which have Vata-pitta shamaka (pacifying)7-8 Out of 13 ingredients, 10 show the property of Vatarakta Shamaka which finds a solid base for treatment of Vatarakta (Gout) with raised uric acid. Overall, the aforesaid Ayurvedic therapeutics conclude that the preparation of Punarnava amrita guggulu with twelve ingredients are enriched for the properties that certainly prove better in Vatarakta as well as in other Vata diseases.

References

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Copyright

Copyright © 2022 Dr. Divya Charan, Dr. Pramod Kumar Mishra, Dr. Indu Sharma. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.