| CTRI Number |
CTRI/2018/01/011537 [Registered on: 24/01/2018] Trial Registered Prospectively |
| Last Modified On: |
10/01/2018 |
| 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 clinical trial to study the effect of two drugs, Rasnadidashmool kwatha and Erandadi kwath in patients of Amavata (Rheumatoid Arthritis). |
|
Scientific Title of Study
|
To evaluate upshayatmaka effect of Rasnadidashmool kwath in disintegration of etiopathogenesis of 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 Aditaya Nath Tewari |
| Designation |
Associate Professor |
| Affiliation |
Ch. Brahm Prakash Ayurveda Charak Sansthan |
| Address |
PG Department of Rog Nidana and Vikriti Vigyan Ch Brahm Prakash Ayurved charak Sansthan khera Dabar Najafagrh New Delhi 110073
D block Room no-D6 Ch Brahm Prakash Ayurved Charak Sansthan khera Dabar Najafgarh, New Delhi 110073
New Delhi
DELHI
110073
India |
| Phone |
9711434847 |
| Fax |
|
| Email |
dr.aditaya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditaya Nath Tewari |
| Designation |
Associate Professor |
| Affiliation |
Ch. Brahm Prakash Ayurveda Charak Sansthan |
| Address |
PG Department of Rog Nidana and Vikriti Vigyan Ch Brahm Prakash Ayurved charak Sansthan khera Dabar Najafagrh New Delhi 110073
D block Room no-D6 Ch Brahm Prakash Ayurved Charak Sansthan khera Dabar Najafgarh, New Delhi 110073
New Delhi
DELHI
110073
India |
| Phone |
9711434847 |
| Fax |
|
| Email |
dr.aditaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anant Kumar |
| Designation |
M D Scholar |
| Affiliation |
Ch. Brahm Prakash Ayurveda Charak Sansthan |
| Address |
PG Department of Rog Nidana and Vikriti Vigyan Ch Brahm Prakash Ayurved charak Sansthan khera Dabar Najafagrh New Delhi 110073
A Block, Room No.-15, Ch Brahm Prakash Ayurved Charak Sansthan khera Dabar Najafgarh, New Delhi 110073
New Delhi
DELHI
110073
India |
| Phone |
8384086212 |
| Fax |
|
| Email |
kumaranant530@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch. Brahm Prakash Ayurved Charak Sansthan Hospital,
Khera Dabar,Najafgarh, New Delhi-110073 |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabur Najafgarh New Delhi 110073 |
| Type of Sponsor |
Other [State Government Ayurvedic College] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Rog nidan and Vikriti vigyan |
CBPACS Khera Dabur Najafgarh New Delhi 110073 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anant Kumar |
Ch Brahm Prakash Ayurved Charak Sansthan Hospital |
OPD No.20 of Rog nidan and Vikriti vigyan and OPD No. 22 of Aatyayika Chikitsa, CBPACS, Khera Dabar Najafgarh New Delhi 110073
New Delhi
DELHI |
8384086212
kumaranant530@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ch Brahm Prakash Ayurved Charak Sansthan Government of NCT Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients of Amavata without any other co-existing disease
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erandadi Kwath |
48gm BD in kwath form for 35 days |
| Intervention |
Rasnadidashmool Kwath |
48gm BD in kwath form for 35 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1-Amavata of any dosha Anubandha
2-Diagnosis of Amavata as per symptoms described in Madhav Nidana
3-Diagnosis of Rheumatoid arthritis as per ACR criteria
|
|
| ExclusionCriteria |
| Details |
1-Pregnant women and lactating mother
2-Patients of RA with know case of rheumatic fever juvenile RA, Ankylosing spondylitis
3-Patients of RA with complications like deformity
4-Any other disorder with Amavata |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptomatic relief in cardinal signs and symptoms of patients
Improvement in DAS-28 Score |
35 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective improvement in the patients will be assessed by adopting suitable scoring pattern.
Decrease in elevated levels of CRP,ESR,RA factor and other biochemical parameters.
Assessment of grip strength and walking time by suitable method. |
35 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
30/01/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
To Evaluate Upshayatmaka effect of Rasnadidashmool kwath in disintegration of etiopathogenesis of Amavata |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Amavata (rheumatoid arthritis) is one of the dreaded disease that mankind facing day by day. It not only affects the social and economic position of individual and his family but also leads to draining of national resource due to the work hours lost, resulting in diminished production. Amavata (RA) is reported to be 1-2% of general population with male and female ratio 3:1. Rasanadidahmool kwath mentioned in Chakradutta in Amavata rogadhikara which have the properties of Amahar, Shothahar, and Shoolhar. and Erandadi kwath as comprative arm mentioned in Bhashajya Ratnavali has also shows the same property. The primary aim of this research is to find out potency of both drug in Amavata (RA) and which one is better.
Asssesment criteria- 1- Objective parameters like CRP, RA-factor, ESR and other will be assessed before and after treatment.
2-Subjective improvement will be assessed by adopting suitable scoring method. Study type- Randomized comparative clinical trial Study time- 24 months Intervention time- 35 days Sample size- 100 (50 in each group) Group-A- The trial drug Rasnadidashmool kwath 48gm BD Group-B- The comparative drug Erandadi kwath 48 gm BD |