| CTRI Number |
CTRI/2021/08/035355 [Registered on: 03/08/2021] Trial Registered Prospectively |
| Last Modified On: |
02/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“EVALUATION OF RUKSHA VIRECHANA AND SNIGADHA VIRECHANA IN AMAVATA
“(RHEUMATOID ARTHRITIS)†|
|
Scientific Title of Study
|
EVALUATION OF RUKSHA VIRECHANA AND SNIGADHA VIRECHANA IN AMAVATA (RHEUMATOID ARTHRITIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritu patel |
| Designation |
Pg scholar (Panchkarma) |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN |
| Address |
DEPARTMENT OF PANCHAKARMA ,PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN
Pantajali Yog Peeth Phase 1 Roorkee Road Haridwar Uttarakhand
DEPARTMENT OF PANCHAKARMA,PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN
Pantajali Yog Peeth Phase 1 Roorkee Road Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7304712675 |
| Fax |
01334-244805 |
| Email |
patel.ritu92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Ruchi Gupta |
| Designation |
Associate professor |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN |
| Address |
DEPARTMENT OF PANCHAKARMA ,PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN Pantajali Yog Peeth Phase 1 Roorkee Road Haridwar Uttarakhand
DEPARTMENT OF PANCHAKARMA,PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN Pantajali Yog Peeth Phase 1 Roorkee Road Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9469063888 |
| Fax |
01334-244805 |
| Email |
ruchigupta1610@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Ruchi Gupta |
| Designation |
Associate professor |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN Pantajali Yog Peeth Phase 1 Roorkee Road Haridwar Uttarakhand
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN Pantajali Yog Peeth Phase 1 Roorkee Road Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9469063888 |
| Fax |
|
| Email |
ruchigupta1610@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurvedic College Haridwar Patanjali Bhartiya Anusandhan Sansthan Haridwar |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurvedic College Haridwar Patanjali Bhartiya Anusandhan Sansthan Haridwar |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Patanjali
Yogpeeth Phase 1 Rookree Road , Haridwar Uttarakhand
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| Ritu Patel |
Patanjali Ayurveda Hospital |
OPD no. 4 Department
of Panchkarma
Patanjali Ayurveda
Hospital Patanjali
Bhartiya Ayurvigyan
Avum Anusanthan
Sansthan
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL |
7304712675
patel.ritu92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PAC/IEC/2019-20/05 |
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, (2) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, (3) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: Rheumatoid arthritis , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Age 10- 60 years
• Either sex
• Patients with classical features of Amavata
• Patient who fit for VIRECHANA KARMA |
|
| ExclusionCriteria |
| Details |
Age < 10 and > 60 years
• All connective tissue disorders other than rheumatoid arthritis
• Complication including contractures nodule etc.
• Having severe crippling deformity
• Patients with history of any direct or indirect trauma to joints.
• Pregnancy & lactating mothers.
• Patients who are unfit for VIRECHANA KARMA.
• Any major systemic disorder like CA, CRF, Liver Cirrhosis, CAD, DMD etc. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameters
1. Sandhi Ruja ( joints pain)
2. Sandhi Shotha (joint swelling)
3. Stabdhata (stiffness)
4. Uahanata (Warmness over the affected joint)
5. Sparshashyata (tenderness over the affected joint)
ASSOCIATED COMPLAINTS:
1. Angamarda (fatigue) 2. Aruchi (anorexia)
3. Jwar (fever)
4. Alasya (lethargy)
5. Nidranash (Insomnia) |
1,13,30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
OBJECTIVE PARAMETERS:
1. RA -Factor
2. ESR
3. CRP
4. ASO |
1,13,30 |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/08/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
IN THIS TRIAL,WE ARE SELECTING THE PATIENTS OF AMAVATA IN WHICH WE WILL DO THE INTERVENTION IN TWO GROUPS (15 PATIENTS IN EACH GROUP). IN ONE GROUP, WE WILL INTERVENE WITH VIRECHANA KARMA WITH AVIPATI CHURNA ,WHEREAS IN OTHER GROUP, WE WILL INTERVENE WITH VIRECHANA KARMA WITH ARAGVADHA AVLEH AND ASSESSMENT SHOULD BE DONE ON THE BASIS OF PARAMETERS DONE DURING PRE- TREATMENT AND POST-TREATMENT |