| CTRI Number |
CTRI/2020/04/024674 [Registered on: 16/04/2020] Trial Registered Prospectively |
| Last Modified On: |
05/04/2020 |
| 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
|
Ayurvedic Management of Rheumatoid Arthritis |
|
Scientific Title of Study
|
An open labelled randomised controlled parallel group clinical study to evaluate the efficacy Of PRASARINI SANDHANAM in management of AMAVATA W.S.R TO 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 |
Dr Ramyashree Nagendra |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room No 304
Department of Kayachikitsa
Sri Sri College Of Ayurvedic Science and Research
21st KM Kanakapura main road
Udayapura PO
Bangalore
KARNATAKA
560082
India |
| Phone |
9663732231 |
| Fax |
|
| Email |
ramyashreenagendra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopala Krishna G |
| Designation |
Professor HOD |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room No 304
Department of Kayachikitsa
Sri Sri College Of Ayurvedic Science and Research
21st KM Kanakapura main road
Udayapura PO
Bangalore
KARNATAKA
560082
India |
| Phone |
9448173128 |
| Fax |
|
| Email |
getgopee@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopala Krishna G |
| Designation |
Professor HOD |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room No 304
Department of Kayachikitsa
Sri Sri College Of Ayurvedic Science and Research
21st KM Kanakapura main road
Udayapura PO
Bangalore
KARNATAKA
560082
India |
| Phone |
9448173128 |
| Fax |
|
| Email |
getgopee@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital
21km Kanakapura Road, Udayapura PO , Bangalore 560082 |
|
|
Primary Sponsor
|
| Name |
Dr Ramyashree Nagendra |
| Address |
Room No - 304, Dept of Kayachikitsa, Sri Sri College of Ayurvedic Science and Research , 21st km udayapura, Kanakapura Road, Bangalore
|
| Type of Sponsor |
Other [PG Scholar] |
|
|
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 Ramyashee Nagendra |
Sri Sri College of Ayurvedic Science and Research Hospital |
Room No - 304, Dept of Kayachikitsa, Sri Sri College of Ayurvedic Science and Research, 21st km Udayapura, Kanakapura road
Bangalore
KARNATAKA |
9663732231
ramyashreenagendra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical committee |
Approved |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M060||Rheumatoid arthritis without rheumatoid factor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Prasarini Sandhanam |
Ingredients - Gandha prasarini, Guda, Lashuna, Panchakola churna, Dose of Sandhana- 15ml TID mode of administration - orally no of days - 30 |
| Intervention |
Simhanada Guggulu |
Ingredients - Harithaki, Vibhitaki, Amalaki, Shuddha Gandhaka, Shuddha Guggulu, Eranda Taila ,Dosage - 2 TID mode of Administration - orally no of days -30 |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to give informed consent for research
2. Subjects who satisfy 4 criteria out of 7 of ARA
3. Subjects with classical signs and symptoms of Amavata |
|
| ExclusionCriteria |
| Details |
1. Subjects suffering from Rheumatoid arthritis secondary to any systemic diseases
2. Patients on any other medications like DMARD, NSAID, Corticosteroids
3. Patients having complications like swan neck deformity, ulnar deviation and any other diseases which interfere with the course of disease and treatment will be excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in General Functional Capacity |
On 45th day the assessment will be done |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To elicit the Quality of Life in patients with Amavata w.s.r to Rheumatoid Arthritis |
15th, 30th, 45th day |
|
|
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)
|
26/04/2020 |
| 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)?
|
|
Brief Summary
|
Rheumatoid Arthritis is one of the common autoimmune diseases affecting 0.8 - 1% of adult population in society. It is the most common form of chronic inflammatory arthritis and often results in joint damage and physical disability. Treatment given in contemporary science are DMARD, NSAID, glucocorticoids which results in many complications on long term use like nausea, diarrhoea, vomiting, stomatitis, mood swings etc:-. Hence effective management is to be explored. Simhanada Guggulu which is proven to have effective results in management of Rheumatoid arthritis is taken as controlled group. Its efficacy is compared with Prasarini Sandhanam which is having drugs like Gandha prasarini, lacuna, panchakola and guda. This new formulation is taken for trial group and is expected to have better results due to its anti arthritic and anti inflammatory properties of drugs. 1. To evaluate effect of prasarini sandhanam in management of Amavata w.s.r to Rheumatoid Arthritis 2. To re-evaluate effect of Simhanada Guggulu in management of amavata w.s.r to Rheumatoid Arthritis 3. To compare the efficacy of Prasarini Sandhanam and Simhanada Guggulu in management of amavata w.s.r to Rheumatoid Arthritis. Null Hypothesis H0 - Efficacy of Prasarini Sandhanam is equal to efficacy of Simhanada Guggulu in management of Amavata w.s.r to Rheumatoid Arthritis Research Hypothesis H1 - Efficacy of Prasarini Sandhanam is not equal to efficacy of Simhanada Guggulu in management of Amavata w.s.r to Rheumatoid Arthritis
|