“UPSHAYATMAK STUDY OF PATHYADI CHURNA IN AMAVATA (R.A.) WITH SPECIAL REFRENCE TO ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ANTI BODY LEVEL".

 

ABSTRACT

       Amavata is a disease of vitiated vata associated with Ama and it persists with multiple systemic involvements mostly affecting the bony joints. The disease starts with minor symptoms, but may develop and extend to all over the body wherever Ama is going to get lodged along with vitiated vayu. As the disease progresses additional symptoms with complications like kanja, pangulya etc may be seen. Rheumatoid arthritis presents with more similar features of Amavata. It exhibits either as oligo or poly arthritis with symmetrical involvement alongwith inflammation, stiffness, tenderness etc. It is also a troublesome long persisting disorder having articular as well as extra articular signs and symptoms, yielding socioeconomically problems and unable to have self care even. As per the data available 5% of the total population of the world is said to be affected with crippling disorder. It is estimated that females are affected three times that of the males usually manifests from 20-60 years of life. It is an autoimmune disease in which the immune system of the body attacks its own tissues i.e. h ere own cartilage and joint linings characterized by persistent inflammation of peripheral joints with associated systemic features. Rheumatoid arthritis is a chronic and disabling condition that causes joint destruction and functional decline unless early treatment occurs. The prevention of disability in RA may be further enhanced with detection in the preclinical stage. Furthermore, accurately identifying individuals at risk for the development of RA during the preclinical phase of the illness is important, since this would allow for the primary prevention of this disease. At present, little is known about markers for preclinical RA. such as rheumatoid factor (RF) and the anticyclic citrullinated peptide (anti-CCP) have been shown to predate the clinical diagnosis of Rheumatoid arthritis, Another potential marker for increased risk of RA may be C-reactive protein (CRP), since CRP is a sensitive marker of systemic inflammation and is elevated in patients with RA.

 

Pathyadi Churna:   Pathyadi Churn described in Chakradutta under Amavata Rogadhikar. The primary herbal ingredients of Pathyadi Churna are  Pathya (Terminalia Chebula), (Shunthi) Zingiber officinale, Yawani (Ajwayan) Trachyspermum ammi in equal quantity.

 

          Reference: Chakrapanidatta. Amavata Adhikara (chapter 25)

          Anupana of the Pathyadi churna – Ushnaodak

          Dose- 5 gm BD with lukewarm water

          Uses:-Amavata, Sotha , Mandagni

          Keywords: Pathyadi Churna, Amavat, Ama, Rheumatoid Arthritis.

 

 

 

 

 

OUTLINE OF THE PROPOSED RESEARCH WORK

ABSTRACT OF SYNOPSIS -

I.                   Title of the Research Work:

“UPSHAYATMAK STUDY OF PATHYADI CHURNA IN AMAVATA (R.A.) WITH SPECIAL REFRENCE TO ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ANTI BODY LEVEL"

 

II.                Importance/ Rationale of Proposed Investigation:

Amavata (Rheumatoid arthritis) is an auto-immune disease¹ with an aggravation of Vata dosha and accumulation of Ama² in different body parts, including joints with significant inflammatory changes and symmetrical polyarthritis. Ama, the metabolic byproducts that do not undergo oxidation, get lodged in body tissues and joints, which leads to symptoms such as pain, stiffness and swelling. Therefore, Amavata initially starts as a metabolic disorder with symptoms of indigestion and loss of appetite, which later encroaches on all the tissues, especially bones, muscles, joints, and multiple organs. The non-metabolized Ama goes into circulation and causes blockage of all the microchannels that provide nutrition to body parts; various tissues, especially connective tissues, get damaged; thus, disease manifestation occurs. The persistent inflammatory changes, mainly confined to the joints, significantly damage the joints' cartilage and bone.

Overview of Disease- Rheumatoid Arthritis (Amavata)

Rheumatoid arthritis is an auto-immune disorder triggered by some infection and genetic pre-deposition. Joint involvement in rheumatoid arthritis is usually symmetrical with pain, swelling, tenderness, and restricted movement of joints. Modern science treats the disease by using DMARDs, steroids, and NSAIDs. Amavata is confined to Madhyam-Rogamarg³, affecting Asthi and Sandhi as chief sites, and has clinical similarities with rheumatoid arthritis(R.A). The symptoms include sandhi shool, sandhi shoth, and sandhi graha. As per Ayurveda's philosophical concept, the aetiology of the disease is heavy food intake or intake of food that is difficult to digest, indulgence in excessive sexual intercourse, and getting nourished by tubers and leafy vegetables. These conditions generate metabolic disturbance, resulting in the formation of Ama; further, vata gets vitiated due to the same reasons, leading to disturbance of moortha Kapha and pitta humors. This dosha disturbance affects the basic body tissues, especially the Shleshma Sthana in Sandhi pradesha, causes inflammatory changes in the presence of vitiated pitta dosha, and gradually disease manifestation occurs⁴.

 

III.             Scope of Proposed Investigation:

Rationale behind the selection of Pathaydi Churna:-

     The topic of Upshayatmak Study of Pathyadi Churna in Amavata (R.A.) with Special Reference to ANTI-CCP⁵ has been selected to validate the efficacy of Pathyadi Churna in Amavaat patients and evaluate the effect of PATHYADI CHURNA⁵ on ANTI-CCP Level as very little work has been done on Pathyadi Churna. In the present scenario, viruddhahara has become very common due to irregular diet & dietary habits and negligence due to busy lifestyle. The cascading effects of these improper food combinations and habits ruin our health & vitality.

A recently published research work on a clinical study on the combined effectiveness of Pathyadi Churna and Kshara Basti in Amavata (Rheumatoid Arthritis) wherein the biochemical analysis in respect of C-Reactive Protein Level has not been performed; hence, the proposed study to validate the effect of Pathyadi churna on the inflammatory marker Anti CCP Level is relevant.

 

Rationale behind the selection of disease Amavata:–

Rheumatoid Arthritis (Amavata) is an autoimmune inflammatory disease in society & is an abnormal pathological condition of joints. Now a day’s prevalence of the disease has increased due to irregular dietary habits, faulty diets, hectic lifestyles etc. All these factors are contributing to the occurrence of this disease. Acharya Madhavkar has mentioned Amavata in the list of krichasadhya diseases and available modern medication/ treatment of amavata/ R.A having many adverse effects and long-term complications. Therefore, Upshayatmak Study of Pathyadi Churna in Amavata (R.A.) with special refrence to Anti-CCP, level, it has been undertaken to evaluate the efficacy of Pathyadi churn in Amvata for study.

 

IV.             Location:

a)      Organization/Department where the work is to be done – The study will be conducted under Mandsaur Institute of Ayurvedic Education & Research , Mandsaur, M.P.

b)      Geographical Area of Investigation, if any- The study will be conducted at Shubhdeep Ayurved Medical College & Hospital and P.G. Dept. of Rog Nidan Avum Vikriti Vigyan, Indore 452020 (M.P). 

 

V.                Objective of the proposed study:

·         To study etiopathogenesis and prevalence of Amavata.

·         To study the Upashayatmak efficacy of Pathyadi Churna in Amavaat.

·         To evaluate the effect of PATHYADI CHURNA on ANTI-CCP Level.

 

VI.             Review of Work done on the Subject:

                                i.            P. Madhavikutty (2015) Comparative Clinical Study on Musta, aswagandha and Pancakarma Therapy in Amavata (Rheumatoid Arthritis)

 

                              ii.            Praveen Kuma (2018) The Management of Amavata (Rheumatoid Arthritis) with Vatari Guggulu and Brihat Simhanada Guggulu

 

                            iii.            Sandip D Bansode (2020) A Comparative Study of Haritaki Prayoga and Trivrutadi Churna in the Management of Amavata Rheumatoid Arthritis

 

                            iv.            Bera pabitra kumar  (2018) Clinical Study to evaluate the Therapeutic Effect of Balaguducyadi Basti and Baluka Swedan in the Case of Amavata (Rheumatoid Arthritis).

 

                              v.            Sudhanshu K. Meher (2015) Clinical Evaluation of Vyoshadi Guggulu and Panchasama Churna in the Management of Rheumatoid Arthritis: An Open-Label, Single-Arm, Prospective Study.

 

                            vi.            RR Kulkarni  (2016)  Efficacy of an Ayurvedic Formulation In Rheumatoid Arthritis: A Double-Blind, Placebo-Controlled, Cross-Over Study

 

                          vii.            Archana Negi (2019) A Clinical Study to Evaluate the Efficacy of Hingwadi Churna and Rasnadashmula Kwatha in Amavata with Special Reference to Rheumatoid Arthritis.

 

                        viii.            Divya Gupta  A Comparative Study to Evaluate the Rujahara (Analgesic) Effect of Virechana Karma and Vaitarana Basti in Amavata (Rheumatoid Arthritis).    

 

                            ix.            Saroj Kumar Debnath A Clinical Study on the Management of Amavata (Rheumatoid Arthritis) with Simhanada Guggulu and Alambushadi Churna Tablet.

 

                              x.            SK Tiwari Clinical Evaluation of Alambushadi Compound and its Vasti in the Management of Amavata (Rheumatoid Arthritis).

 

                            xi.            Rachana Tiwari, (2020) Upashayatamak Study of Kansa Haritiki in Amavata (R.A) W.S.R to  CRP( C- REACTIVE PROTEIN) Level.

 

VII.          Research gaps identified in the proposed field of investigation:

Key words	Pubmed	Ayush Portal	Dhara	Doaj	Google Scholar
Amavata	67	94	60	34	210
Ama	78	168	50	45	360
Pathyadichurna in Amavata	55	15	40	10	34
Pathyadi Churna in amavata w.s.r. to Anti CCP level	0	0	0	0	0

 

1.      There are few survey study done which shows the effect of other classical drugs in Amavata. But this study is specific.

 

2.      No such work has been conducted on “UPSHAYATMAK STUDY OF PATHYADI CHURNA IN AMAVATA (R.A.) WITH SPECIAL REFRENCE TO ANTI CYCLIC   CITRULLINATED PEPTIDE (ANTI-CCP) ANTI BODY LEVEL”.

 

VIII.       Research Methodology:

Reseaech Question:- Is Pathyadi Churna is effective in Amavata (R.A) with Special refrence to Anti Cyclic Citrullinated peptide (Ant- CCP) level.

Hypothesis to be tested: 

Null Hypothesis:

Pathyadi Churna is not effective in Amavata (R.A) with Special refrence to Anti Cyclic Citrullinated peptide (Ant- CCP) level.

 

Alternate hypothesis:

Pathyadi Churna is highely  effective in Amavata (R.A) with Special refrence to Anti Cyclic Citrullinated peptide (Ant- CCP) level.

Source of information:

a)      Organization/ Depatrtment where the work is to be done: – The study will be conducted under Mandsaur Institute of Ayurvedic Education & Research , Mandsaur, M.P.

b)       Geographical Area of Investigation, if any- The study will be conducted at Shubhdeep Ayurved Medical College & Hospital and P.G. Dept. of Rog Nidan Avum Vikriti Vigyan, Indore- 452020 (M.P). 

 

Literary source:

All the Classical Samhitas, Ayurvedic and Modern books, Magazines, Articles, Publications, Internet, Website will be reviewed and documented for the intended study.

All aspects regarding the subject will be collected from Modern and Ayurvedic texts and other relevant publications about Amavaat and Rheumatoid Athritis.

Sample source:

Patients attending the OPD and IPD of Shubhdeep Ayurveda medical college and hospital Indore.

M.P. and other referral Hospital will be made and patients fulfilling the criteria of diagnosis of Amavata (R.A) as per the Proforma will be selected for the study.

Drug Source:

The drugs will be collected from the local area for the therapy.

Pathyadi Churna will be prepared in the pharmacy of the College.

 

·         Tools and Techniques of Research:

 

METHODOLOGY (MATERIAL AND METHOD):-

 

Criteria of Diagnosis:

 

The diagnosis will be done on the basis of signs and symptoms as per ayurvedic texts as well as modern text. The criteria of diagnosis A.R.A.(1987) will also be followed for additional information for comparision of signs and symptoms.

 

American Criteria is mentioned as follows:-

 

1)    Morning stiffness lasting for at least 1hr. and for>6 weeks.

2)    Arthritis of 3 or more of 14 possible joints area.

3)    Arthritis of hand joints, wrist metacarpophalangeal, interphalsngeal, metatarsophalangeal, joints > 6 weeks.

4)    Symmetrical arthritis.

5)    Rheumatoid nodules-subcutaneous nodules over bony prominence.

6)    Serum rheumatoid factor.

7)    Radiological changes.

 

All routine investigations will be carried out to exclude other pathology.

 

A.    INCLUSION CRITERIA:

 

1.    Patient with presence of classical sign and symptoms along with modern parameter of Amavaat (RA).

2.    Age group between 20-60 yrs.

3.    Patients giving informed consent for the trial.

 

B.     EXCLUSION CRITERIA:

 

1.      Patients who left the treatment in between

2.      Patients who are steroid dependent for relief of symptom

3.      Patients representing with complication like SLE, Endocarditisetc

4.      Patients with contractures of joints of severe deformities will not be included.

 

C.    Discontinuation Criteria:

 

1.      Patients who developed hypersensitivity for any constituent of the selected formulation.

2.      Patients who discontinued the treatment themselves due to any reason.

 

D.    Laboratory investigations:-

 

•        ANTI CCP Test

•        ESR Test

•        RA Factor Test

 

E.     Plan of Study :

 

Study design:     Randomized control study.

 

Sample Size:- In this study minimum 60 patient from the O.P.D. and I.P.D of Shubhdeep Ayurved Medical College and PG Institute complaining with Amavata (Rheumatoid Arthritis).

 

Diagnostic criteria:-Diagnosis based on incliusion and Exclusion Criteria

 

PROCEDURE PLANNED:-

 

 

A.    Conceptual Study:

 

1.     Case Study: Amavata Patient according Ayurvedic and modern texts.

2.     Interventional Study: Upshayatmak role of  Pathyadi Churna on Amavata.

 

B.     Drug Study:

 

1.     Collection of The Drug: Pathyadi Churna

 

The drug will be prepared in the Pharmacy of Shubhdeep Ayurved Medical College on the basis of Chakradutta Amavata Rogadhikr  (12/44).

 

C.    Upashayatmak Study:  Internal medicine will be applied/used for 30 days.

 

•        Effect of the medicine will be observed on 30 days.

•        If any complications arise after starting the treatment, i.e. within 30 days, patient will        be referred to the Pharmacovigilance department.

•        Selection of subjects: 60 patients will be selected randomly from OPD, IPD, and   camps of ShubhdeepAyurvedic medical College & Hospital, Indore (M.P.)

•        Patients will be selected as per inclusion criteria.

 

Upashayatmak Group:

•        Sample size: 60

•        Drug : Prepared Pathyadi Churna

•        Form of Drug: Churna

•        Dose of internal administration : 5 gm BD

•        Medium: luke warm water.

•        Duration: 30 days

•        Type of study: Simple clinical (Upshyatmak) trial

•        Data collection: On 1st, 30th Days

•        Data collection by: Ph. D Research scholar

•        Adverse Drug Reaction:

 

•        If any ADR will be seen patient will be dropped out from the study and immediately local or central pharmacovigilance cell will be informed and urgently precautionary medicines will be administered.

 

D.    DATA COLECTION & METHOD:-

 

Assessment:

Subjective criteria:-

1            Sandhishoola (Pain in joints)

2            Sandhishotha (Swelling in joints)

3            Sparshasahyata (Tenderness in joints)

4            Sandhigraha (Stiffness in joints)

5            Angamarda

6            Aruchi

7            Trishna

8            Aalasya

9            Gaurava

10        Apaka,

11        Vairasyata,

12        Agnimandya

13        Daha,

14        Bahumutrata

15        Vidvibandha

16        Jadya

17        Nidraviparyaya

E.     Objective Criteria :-

1            Anti CCP Test

2            ESR Test

3            RA Factor Test

Grading –

                         Sandhishoola (Pain in joints):-       

-          No Pain                                                                                                     0

-          Mild pain of low intensity causing no disturbance in routine work         1

-          Moderate pain but bearable                                                                      2

-          Moderate pain hampers the daily routine work                                        3

-          Severe pain causing definite interruption in routine work                       4

Sandhishotha (Swelling in joints):-         

-          No Swelling                                                                                              0

-          Mild Swelling                                                                                           1

-          Moderate swelling                                                                                    2

-          Huge Swelling                                                                                          3

-          Very huge swelling                                                                                   4

 

Sparshasahyata (Tenderness in joints):-

-          No Tenderness                                                                                          0

-          Subjective experience of tenderness                                                        1

-          Wincing of face on pressure                                                                     2

-          Wincing of face on pressure and withdrawal of affected part                3

-          Resists to touch                                                                                        4

       Sandhigraha (Stiffness in joints):-

-          No restriction of movement                                                                     0         

-          Restriction u to 0 to 20 %                                                                        1

-          Restriction up to 20 to 40 %                                                                    2

-          Restriction up to 40 to 60%                                                                     3

-          Above 60 %                                                                                              4

Angamarda  :-                     

-          No Angamard                                                                                          0

-          Occasional Angamarda but Patients is able  to do usual work                1

-          Continuous Angamarda but Patients is able to do usual work                2

-          Continuous Angamarda which hampers routine work                             3

-          Patient is unable to do any work                                                              4

Aruchi :-

-          Normal desire for food                                                                             0

-          Eating timely without much desire                                                          1

-          Desire for food, little late than normal time                                             2

-          Desire for food only after long intervals                                                  3

-          No desire at all                                                                                         4

Trishna:-                              

-          Normal feeling of thirst                                                                            0

-          Frequent feeling of thirst but quench with normal amount of liquid       1

-          Satisfactory quench after increases intake of fluids but no awakening

       during night                                                                                              2

-          Satisfactory quench after increases intake of fluids with regular

       awakening during right                                                                            3

-          No quench after heavy intake of liquid                                                   4

Aalasya:-

-          No Aalasya                                                                                               0         

-          Starts work in time with efforts                                                               1

-          Unable to start work in time but completes the work                              2

-          Delay in start of work and unable to complete it                                     3

-          Never able to start the work and always likes rest                                   4

Gaurava:-                             

-          No feeling of  heaviness                                                                           0         

-          Occasional heaviness in body but  can do usual work                             1

-          Continous heaviness in body but can do usual work                               2

-          Continuous heaviness which hampers usual work                                   3

-          Unable to do any work due to heaviness                                                 4

Apaka:-

-          No apaka at all ( Normal digestion)                                                         0         

-          Occasional indigestion once or twice a week in one meal                       1

-          Occasional indigestion 3 to 5 time / week in one meal                            2

-          Indigestion 3 to 5 times / week in both  meals                                         3

-          Indigestion after every meal                                                                    4

Agnimandya:-

-          No Agnimandya                                                                                       0         

-          Occasional Agnimandya 1 to 2 times/ week                                            1

-          Agnimandya 3 to 4 times/ week                                                              2

-          Agnimandya 4 to 6 times / week                                                             3

-          Continous Agnimandya                                                                           4

Vairasyata :-

-          Normal taste of mouth                                                                             0

-          Occasional sensation of unpleasant taste                                                 1

-          Continuous sensation of unpleasant taste but vanishes                            2

-          Continuous mild sensation of unpleasant taste which persist

after eating                                                                                               3

-          Severe unpleasant taste throughout the day                                             4

 

Daha:-

-          No burning sensation                                                                                0

-          Occasional retro sterna burning                                                                1

-          Occasional retro sterna, plam and sole burning                                        2

-          Intermittent burning sensation throughout body                                     3

-          Continuous burning sensation throughout body                                      4

Bahumutrata:-                     

-          Absent                                                                                                      0

-          Urine > 2 times/ Night                                                                              1

-          Urine > 3 times/ Night                                                                              2

-          Urine > 5 times/ Night                                                                             3

-          Urine > 7 times/ Night                                                                              4

Vidvibandha :-                     

-          Absent                                                                                                      0

-          Motion once a day but not a regular interval                                           1

-          Alternate day                                                                                            2

-          Interval for more than one day                                                                3

-          Interval for more than two day                                                                4

Nidraviparyaya:-

-          Normal Sleep                                                                                            0

-          Disturb sleep during night with short naps during day                            1

-          1 to 2 hrs reduction in night sleep with gross increase in day sleep         2

-          3 to 5 hrs reduction in night sleep with gross increase in day sleep         3

-          Wakes during night & sleep during day                                                   4

Jadya:-

-          No morning stiffness                                                                                0

-          Morning stiffness >  1/2 hrs but < 1 hrs                                                   1

-          Morning stiffness >  1 hrs but < 6 hrs                                                      2

-          Morning stiffness >  6hrs but < 12 hrs                                                     3

-          Stiffness all the day through                                                                    4

FINAL ASSESSMENT OF RESULT:- The subjective and objective parameters of base line data to post medication will be compared for assessment of the results. All the result will be analyzed statistically for ‘p’ value using paired - t test.

 

IX.             Expected Outcome of Research:-

It may be a boon to provide such a cost- effective and safe medicine to the society as many people suffer from this troublesome disease which can end up in a series of complications and disturbed life, stress and uneasiness. Once the stablishment of effectiveness of  pathyadi churna inAmavata, the more effective prepration can be obtained.

 

X.                Tentative Chapterization:-

·                     Introduction

·                     Objectives

·                     Review of Literature

·                     Methodology

·                     Results

·                     Discussion

·                     Conclusion

·                     Summary

·                     Bibliography

·                     Annexures

 

PLAN OF WORK

 

 

 

 

 

I.        BIBLIOGRAPHY:

 

1.      Shukla Vidyadhar Acharya Charaka Samhita, reprinted edition 2006; Chaukhamba Sanskrit pratishthan ch.chi.28/37 : 694

2.      Ashtanga Hridaya of Vagbhatt, commentary by Atridev Gupt Nidana Sthana 8/30 Chaukhamba Prakashan.

3.      Shukla Vidyadhar Acharya Charaka Samhita, reprinted edition 2006; Chaukhamba Sanskrit pratishthan ch.chi.28/37 : 694

4.      https://www.who.int/news-room/fact-sheets/detail/osteoarthritis      Date:    18/12/2024 Time: 13:30

5.      ShastriKashinath. Charaka Samhita. Sutra Sthana. Ch-20. Sl-11. Varanasi. Chaukamba Sanskrit Samsthan. 2009. (vol 1). p269.

6.      Tripathi Brahmanand Charaka Samhita, edition reprinted 2004; Chaukhamba Surbhararati prakashan ch.su.22/4 : 412

7.      Chakradutta of Sri Chakrapanidatta, editon reprint 2010; Chaukhamba Surbhararati prakashan 210-214/22 p149

8.      Acharya G. Shrinivas Panchkarma Illusrated, edition reprinted 2009-2013 Chaukhamba Sanskrit pratishthan,:261

9.      Tripathi Brahmanand Astang Hridayam, Edition reprinted 2007; Chaukhamba Sanskrit pratishthan As.H. Chi. 21/67-69:812

 

Name and Signature of Candidate Name and Signature of Co Supervisor Name & Signature of Supervisor

 

Reference:-

 

1.     Madhavakara, Madhavanidhanam, with Madhukosh commentary, Vijayaraksita and Srikantadatta, Editor Vaidya Jadavji Trikamji Acharya, Chaukambhaorientalia Varanasi, 6^th Edition 2001, P No 186.

 

2.     Long, Fauci, Kasper, Hauserjamesonlascalzo “Harrisions Principal of Internal Medicine 18” Edition, E-Book, 2012, The Mcgraw-Hill Companies INC. Chapter no 321

 

3.     http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/769548

 

4.     Charak Samhita of Agnivesh, Prof. Ravidatttripathi, Chaukhambha Sanskrit Pratishtan Delhi, Second volume ,P. No. 15

 

5.     Charak Samhita of Agnivesh, Prof. Ravidatttripathi, Chaukhambha Sanskrit Pratishtan Delhi, Second volume, P.No. 27.