“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
