| CTRI Number |
CTRI/2018/09/015821 [Registered on: 24/09/2018] Trial Registered Retrospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trail to study the effect of classical Ayurvedic treatment in patients of Rheumatoid Arthritis. |
|
Scientific Title of Study
|
Evaluation of the effect of classical Ayurvedic treatment in the functional improvement of patients with Rheumatoid Arthritis |
| Trial Acronym |
ECAFR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr E T Neelakandan Mooss |
| Designation |
Principal Investigator |
| Affiliation |
Vaidyaratnam Ayurveda Foundation |
| Address |
room no :107,Vaidyaratnam Ayurveda Foundation,vaidyaratnam Road
Thaikkattussery
Ollur
Thrissur
KERALA
680306
India |
| Phone |
9447025338 |
| Fax |
04872355898 |
| Email |
vaf2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudarshan Nair P K |
| Designation |
Chief Research Coordinator |
| Affiliation |
Vaidyaratnam Ayurveda foundation |
| Address |
Room No:109,Vaidyaratnam Ayurveda Foundation,
Thaikkattussery
Ollur
Thrissur
KERALA
680306
India |
| Phone |
9446237396 |
| Fax |
04872355898 |
| Email |
nairsudarsan21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudeesh Kumar S |
| Designation |
Deputy Medical Superintendent |
| Affiliation |
Vaidyaratnam Ayurveda foundation |
| Address |
Room no:108,Vaidyaratnam Ayurveda Foundation,
Thaikkattussery
Ollur
Thrissur
KERALA
680306
India |
| Phone |
9497317627 |
| Fax |
04872355898 |
| Email |
ayur_sudi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ministry of AYUSH, Governament of India,NewDelhi |
|
|
Primary Sponsor
|
| Name |
Ministry of AYUSH Government of India |
| Address |
Ministry of AYUSH
AYUSH Bhawan
B BLOCK
GPO Complex, INA
New Delhi- 110023 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Vaidyaratnam Ayurveda Foundation |
Thaikkattussery, Ollur, Thrissur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR E T NEELAKANDAN MOOSS |
Vaidyaratnam Ayurveda Foundation |
room no 107,Vaidyaratnam Ayurveda Foundation Centre of Excellence in Ayurvedic Management of Chronic Joint Disorder, Vaidyaratnam road,
THAIKKATTUSSERY,OLLUR, THRISSUR, KERALA
Thrissur
KERALA |
9447025338
04872355898
vaf2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| institutional Ethical Committee |
Approved |
| vaidyaratnamCOEethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Rheumatoid Arthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AMRITHOTHARAM KWATHAM,VAISHVANARAM CHOORNAM,RASNASAPTHAKAM KWATHAM,VYOSHADI GULGULU CHOORNAM,KOTTAMCHUKKADI THAILA,BALAGULOOCHYADI THAILA, CHOORNAPINDA SWEDA, PATRA POTTALI SWEDA |
1ST 7DAYS
INTERNALLY:
100ML AMRITHOTHARAM KWATHAM with 5gm VAISHVANARAM CHOORNAM at 6am and 6pm, EXTERNALLY
CHOORNAP PINDA SWEDA with 800GM Shyamaka powder for forty five minutes,
next 14 days
INTERNALLY:
100ml RASNASAPTHAKAM KWATHAM with 1.5gm VYOSHADI GULGULU CHOORNAM 6am and 6pm, EXTERNALLY
PATRA POTTALI SWEDA with 100MLkottamchukkadi thaila for forty five min, 5ml Balaguloochyadi thaila over head every day evening at 5pm |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with either sex with age between 20 to 60 years
2. Presence of any four out of the following seven criteria ( According to 2010, Revised criteria of American college of Rheumatology)
a) Morning stiffness lasting more than 6 weeks
b)Arthritis of three or more joints
c) Arthritis of hands
d) Presence of Rheumatoid nodules
e) Symmetric Arthritis
f) Serum Rheumatoid Arthritis/ ACCP positive
g) Abnormal CRP/ESR
3. Patient willing to participate in the study for 57days |
|
| ExclusionCriteria |
| Details |
1. Patients who developed complications of Rheumatoid Arthritis
2. Patients who are unable to walk without support/ bedridden
3. Patients with poorly controlled Hypertension/ Diabetes/ Cardiac failure/ Hepatic disorder
4. Patients who are diagnosed with other arthritis
5. Alcoholics/ Pregnant woman/ Lactating Woman/ Hypersensitivity to drugs/ Prolonged medications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of the effect of classical Ayurvedic treatment in the functional improvement of patients with Rheumatoid Arthritis |
1st, 7th,21st,42nd AND 57th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish the safety of ayurvedic line of management in Rheumatoid Arthritis |
One and half year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2014 |
| Date of Study Completion (India) |
22/11/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/11/2015 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study is a open clinical trail conducted in Vaidyaratnam Ayurveda foundation, Thrissur, to evaluate the safety and efficacy of Ayurvedic management in Rheumatoid Arthritis ( Amavatam). The trail period is 57days which includes 21 days of IP Treatments and 21 days of OP Treatments followed by 15 days of follow up period. The target is 50 cases. The parameters for assessment includes Objective observations, subjective details, SF (36), DAS 28 Score for will be evaluated statistically.
|