| CTRI Number |
CTRI/2021/02/031540 [Registered on: 25/02/2021] Trial Registered Prospectively |
| Last Modified On: |
16/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A ROLE OF SHOOLHARA KASHAYA AND KAKAMACHYADI LEPA TREATMENT IN AMAVATA (RHEUMATOID ARHTRITIS) |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF SHOOLHARA KASHAYA AND KAKAMACHYADI LEPA WITH
IBUPROFEN TABLET AND DICLOFENAC GEL IN AMAVATA WITH SPECIAL REFERENCE TO
RHEUMATOID ARHTRITIS AN OPEN LABEL RANDOMIZED CONTROLLED CLINICAL TRIAL |
| Trial Acronym |
CSSKKLIDARA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archana Shukla |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No 618 Sixth Floor Academic Block All India Institute of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi
Room No 614 Sixth Floor Academic Block All India Institute of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi 110076
South West
DELHI
110076
India |
| Phone |
9643746101 |
| Fax |
|
| Email |
archanashukla9643@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Shukla |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No 618 Sixth Floor Academic Block All India Institute of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi
Room No 614 Sixth Floor Academic Block All India Institute of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi 110076
South West
DELHI
110076
India |
| Phone |
9643746101 |
| Fax |
|
| Email |
archanashukla9643@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rama Kant Yadava |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No 614 Sixth Floor Academic Block All India Institute of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi 110076
Room No 618 Sixth Floor Academic Block All India Institute of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi
South West
DELHI
110076
India |
| Phone |
9412148437 |
| Fax |
|
| Email |
drrky68@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi 110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Archana Shukla |
All India Institute of Ayurveda |
OPD no 3 Groud Floor Hospital Block All India Institute of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi
South West
DELHI |
9643746101
archanashukla9643@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee All India Institute of Ayurveda New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEEPAN YOGA
SHOOLHARA KASHAYA
KAKAMACHYADI LEPA |
DEEPAN YOGA 3 gm bid after food with lukewarm water
SHOOLHARA KASHAYA 30ml bid empty stomach with anupaan Saindhav lavan or Sita or
Madhu
KAKAMACHYADI LEPA processed in ERANDA OIL twice a day for local application |
| Comparator Agent |
Tablet IBUPROFEN 400 mg
DICLOFENAC GEL |
IBUPROFEN 400 mg bid after food DICLOFENAC GEL twice a day for local application |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having the clinical manifestation of Amavata (RA) according to Ayurvedic
classics - SANDHISHOOL (PAIN), SHOTH (SWELLING), SPARSHASAHTA (TENDERNESS) and STABDHATA (STIFFNESS),Vrishichikadansavata vedana
(pain like scorpion sting), Agnimandya (poor digestion) , Aruchi(anorexia), Gaurav(Feeling
of heaviness of body),Utsaha Hani(lack of interest),Mukha vairasya(Perverted taste) or
having positive RA factor.
2)The 2010 American College of Rheumatology/ European League Against Rheumatism
classification criteria for rheumatoid arthritis Score.
3)Classification criteria for RA (score-based algorithm: add score of categories A–D; a score of 6/10 is needed for classification of a patient as having definite RA).
A. Joint involvement
â–ª 1 large joint 0
â–ª 2-10 large joints 1
â–ª 1-3 small joints (with or without involvement of large joints) 2
â–ª 4-10 small joints (with or without involvement of large joints) 3
â–ª >10 joints (at least 1 small joints) 5
B. Serology (at least 1 test result is needed for classification)
â–ª Negative RF and negative ACPA 0
â–ª Low-positive RF or low-positive ACPA 2
â–ª High-positive RF or high-positive ACPA 3
C. Acute-phase reactants (at least 1 test result is needed for classification)
â–ª Normal CRP and normal ESR 0
â–ª Abnormal CRP or abnormal ESR 1
D. Duration of symptoms
â–ª <6 weeks 0
â–ª >6 weeks 1
4) Patients willing to participate in the research study |
|
| ExclusionCriteria |
| Details |
1) Patients with other systemic complications of RA like RHD, Rheumatic fever, pleural –
pericardial disease.
2) Patients with poorly controlled Hypertension (>160/100 mm of Hg)
3) Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP) >200 mg%
OR HbA1c> 6.5%}
4) Patients diagnosed with other arthritis like gouty arthritis, tuberculous arthritis, etc.
5) Patients who are unable to walk without support and / or confined to wheel chair.
6) H/o hypersensitivity to any of the trial drugs or their ingredients.
7) Patients on prolonged (> 6 weeks) medication with antidepressants, anticholinergic, etc. or
any other drugs that may have an influence on the outcome of the study.
8) Pregnant / lactating woman.
9) Patients who have completed participation in any other clinical trial during the past 6
months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Reduction in VAS Score.
2)Providing the Vednahara (analgesic) effect management of Amavata (RA) with Ayurvedic shaman chikitsa. |
55 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in the quality of life with the help of questionnaires for scaling of W.H.O quality
of life. |
55 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2021 |
| 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="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response (Others) - provided i get due credit
- By what mechanism will data be made available?
Response (Others) - on request subject to institutional consent
- For how long will this data be available start date provided 01-01-2023 and end date provided 21-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
AYURVEDA is an ancient scientific medical knowledge in the world. It has taken the foremost place in the management of crippling diseases, AMAVATA is one of them. The disease Amavata is a most remarkable problem in the society in modern era. In the whole world Rheumatic disease are commonest cause of physical impairment in society. Due to its wide prevalence chronicity, morbidity, crippling nature and lack of effective drug attract to look for suitable remedy of the disease AMAVATA. In Ayurveda, Amavata was first mentioned by Madhavakara (700AD) as a special disease entity where AMA as well VATA plays an important role in the Samprapti (pathogenesis) of the disease. Here KAPHA and VATA are the main vitiated doshas associated with AMA.Ama a product of impaired Pachakagni and 4 Rasdhatwagni is carried by vayu and accumulated at diffused places of vayu as well as different place of the body mainly in the joints by obstruction of shrotas and cause s inflammation. Vitiated Vayu circulates the Ama all over the body through Dhamanies takes shelter in the shleshmasthan (amashaya, sandhi etc.) producing symptoms such as stiff ness, swelling and tenderness in small and big joints.Rheumatoid arthritis an auto immune disease is present all over the world with a prevalence of 0.5-1% of adults. There are adequate studies suggesting that current treatment strategies in conventional science with reference to auto immune disease is not satisfactory. The major focus of management is anti-inflammatory and immune suppressive therapy. The response to immune suppression in auto immune disease is seen in 60-70% initially and subsequently the disease may progress or may stop responding to the drug used. Here we are trying to rescue the 7 patient from the adverse side effects of western medicines. Due to formation of Ama there is heaviness of body, poor digestion, lack of vigor. perverted taste, anorexia etc. ■Reason of taking SHOOLHARA KASHAYA because it helps in the management of Amavata by Pachana of Ama,agni deepan,reduces the inflammation along with vitiated Vata and Kapha and also act as rasayan and balya which improves the quality of life of Amavata patients. ■Reason of taking KAKAMACHYADI LEPA processed in ERANDA TAILA in local application because it acts as a good pacifier of vata dosh which causes Vedna (Pain) that’s why will act as a pain killer ointment STUDY DESIGN – The study is proposed to be an Open Randomized Double Arm Clinical Trial. The patients with fulfilling diagnostic criteria of AMAVATA (RA) will be taken in two groups. The subject attending the OPD of AIIA will be screened and enrolled in the study following ethic of the Institute and the selection criteria. Study Type - Clinical trial (Analytical and Interventional) Masking - Open Interventional Model – Parallel assignment Timing- Prospective Method of sample selection – Randomized sampling Sample size – A total no. of 60 patients of RA will be taken in the proposed clinical trial, in which they will be divided into 30-30 each in control and trial group. Selection of Cases - O.P.D. /I.P.D. wing of Department of Kayachikitsa, All India Institute of Ayurveda on the basis of diagnostic criteria of Amavata (RA) No. of groups - 2 (Group A – TRIAL GROUP, Group B - CONTROL GROUP)
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