| CTRI Number |
CTRI/2022/01/039129 [Registered on: 04/01/2022] Trial Registered Prospectively |
| Last Modified On: |
04/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
“A CLINICAL
STUDY TO EVALUATE THE EFFICACY OF SWARNAPATRI KASHAYA PARISHEKA IN AMAVATA |
|
Scientific Title of Study
|
“A Randomized Open Labelled Controlled Clinical
Study To Evaluate The Efficacy Of Swarnapatri (Cassia
angustifolia) Kashaya Parisheka In Amavata |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jishna Prakash AK |
| Designation |
PG Scholar |
| Affiliation |
sri sri college of ayurveda science and research hospital |
| Address |
Room no.8
Dept of panchakarama
sri sri college of ayurvedic science and research, 21st km kanakapura road, udayapura p.o
Room no.8
Dept of panchakarama
sri sri college of ayurvedic science and research, 21st km kanakapura road, udayapura p.o
Bangalore
KARNATAKA
560082
India |
| Phone |
9686594978 |
| Fax |
|
| Email |
jp.ayu.ak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prajwal Narayan |
| Designation |
Professor, Dept of Panchakarma |
| Affiliation |
sri sri college of ayurveda science and research |
| Address |
Room no.8
Dept of panchakarama
sri sri college of ayurvedic science and research, 21st km kanakapura road, udayapura p.o
Bangalore
KARNATAKA
560082
India |
| Phone |
8951072206 |
| Fax |
|
| Email |
vdprajwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajwal Narayan |
| Designation |
Professor, Dept of Panchakarma |
| Affiliation |
sri sri college of ayurveda science and research |
| Address |
Room no.8
Dept of panchakarama
sri sri college of ayurvedic science and research, 21st km kanakapura road, udayapura p.o
Bangalore
KARNATAKA
560082
India |
| Phone |
8951072206 |
| Fax |
|
| Email |
vdprajwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amruth kesari Depot,
No.18, 1st Cross, Belli Basavangudi,
Chickpet, Bengaluru-560053
Karnataka |
|
|
Primary Sponsor
|
| Name |
Jishna Prakash AK |
| Address |
Dwaraka, p.o chovva, kannur kerala 670006 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| JISHNA PRAKASH AK |
Sri Sri Ayurveda Hospital |
Department Of Panchakarma,
Room No.7.
21ST KANAKAPURA ROAD, UDAYAPURA.PO
BENGALURU 560082
Bangalore
KARNATAKA |
9686594978
jp.ayu.ak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dashamoola Kashaya |
Dashamoola kashaya parisheka for 7 days for a duration of 40minutes |
| Intervention |
Swarnapatri Kashaya |
Swarnapatri kashaya parisheka for 7 days for a duration of 40minutes |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fit for kayaseka and ruksha sweda.
Subjects who satisfy 6 criteria out of 10 of ACR.
Subjects with classical signs and symptoms of Amavata.
Those who are willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
• Subjects suffering from Rheumatoid arthritis secondary to any systemic
diseases.
• Subjects on any other medications like NSAID, corticosteroids.
• Pregnant women and lactating mother.
• Subjects having complications like swan neck deformity, ulnar deviation
and any other diseases which interfere with the course of disease and
treatment will be excluded.
• Subjects who are unfit for kayaseka. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Swelling of the joints.
Reduction in Stiffness of the joints.
Reduction in Tenderness of the joints.
Reduction of Warmth of the joints. |
22 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction of Pain in the multiple joints and in small joints .
Reduction of Morning stiffness which lasts at least an hour.
Reduction of Swelling in the joints.
|
22 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Amavata is one of the dreaded diseases that the mankind faces today. Even though
Amavata is not proved to be fatal, it cripples the affected patients. It can affect many facets of
a patient’s life, viz. his family, occupational and community relationships even. As far as
symptomatology is concerned, rheumatoid arthritis and Amavata are having similarities.
Amavata presents with the cardinal symptoms like gaurava and vruschika damshavat vedana1
. In recent years an intense study of different conditions primarily involving the
musculoskeletal structures (rheumatology) has been made and it revealed that inflammatory
or degenerative changes2
occur in disease like R.A. So, recent scholars are trying to co-relate
Amavata with rheumatoid arthritis. Rheumatoid arthritis occurs throughout the world and in
all ethnic groups3. The overall prevalence of rheumatoid arthritis is 0.8% of the total world
population. In India, the incidence of Amavata (rheumatoid Arthritis) is reported to be 1-2%
of general population with a female to male ratio4
of 3:1.
In chikitsa sutra of Amavata, swedana is one of the lines of treatment5
. Swedana
because of ushna guna acts on sheeta guna of vata and kapha, which in turn mitigates vata
and kapha dosha6
. Parisheka is one of the varieties of sweda. Swarnapatri, Cassia
angustifolia which is having ruksha guna and vata-kapha hara actions7
are widely used in
traditional Chinese medicine, and has anti-inflammatory activity8
, it is useful in relieving people from the condition of osteoarthritis, gout and rheumatoid arthritis9
, and hence
swarnapatri is selected.
Till date there is no satisfactory modern medical management for pain and stiffness
developed for this disease. Therefore patients are continuously looking with hope towards
Ayurveda to overcome the challenge. By considering the pathogenesis and samprapti
ghatakas of Amavata, this research aim to know whether adopting sarvanga parisheka
sweda with swarnapatri kashaya will help in reduction in the pain and stiffness caused by
Amavata. |