| CTRI Number |
CTRI/2020/03/023889 [Registered on: 11/03/2020] Trial Registered Prospectively |
| Last Modified On: |
03/03/2020 |
| 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
|
Treatment for Amavata (Rheumatoid Arthritis) with Vaitarana Basti and Agnilepa in two equal groups of population. |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VAITARANA BASTI AND VAITARANA BASTI WITH AGNILEPA (AMALGAMATED) IN THE MANAGEMENT OF AMAVATA W.S.R. TO RA |
| Trial Acronym |
--- |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya B |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Panchakarma,
Parul Institite of Ayurved and Research,Parul University,Ishwarpura,Waghodia,Vadodara,Gujarat.
Flat no 805, Medical staff quaters,Parul University campus,Limda,Waghodia,Vadodara,Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9844810958 |
| Fax |
|
| Email |
dr.divyadeva3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K B ROY |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Panchakarma,
Parul Institite of Ayurved Parul University,Ishwarpura,Waghodia,Vadodara,Gujarat.
Flat no 801, Medical staff quaters,Parul University campus,Limda,Waghodia,Vadodara,Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9825912141 |
| Fax |
|
| Email |
dr_kbroy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya B |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Panchakarma,
Parul Institite of Ayurved and Research,Parul University,Ishwarpura,Waghodia,Vadodara,Gujarat.
Flat no 805, Medical staff quaters,Parul University campus,Limda,Waghodia,Vadodara,Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9844810958 |
| Fax |
|
| Email |
dr.divyadeva3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of ayurved,Vadodara |
|
|
Primary Sponsor
|
| Name |
Parul University |
| Address |
PARUL INSTITUTE OF AYURVED ISHWARPURA,LIMDA,WAGHODIA,VADODARA,GUJARAT |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Parul Intitute of Ayurveda and Reasearch |
Ishwarapura, Limda, Waghodia, Vadodara, Gujarat |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divya B |
Khemadas Ayurved Hospital |
Parul university
Limda, Waghodia
Vadodara, Gujarat
Vadodara
GUJARAT |
9844810958
dr.divyadeva3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIA-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M058||Other rheumatoid arthritis with rheumatoid factor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
effect of vaitaran basti and vaitarana basti with amalgamated agni lepa |
dose: 325ml
duration: 8days
vaitarana basti is a type of enema for 8days for one group. another is fallowed by vaitaran basti and amalgamated agnilepa for similar duration |
| Intervention |
Vaitarana basti and Amalgamated form of Agnilepa |
dose:325ml
duration: for 8 days.
route: Anal route
frequency: once in day.
vaitarana basti is a type of enema for 8days for one group. another is fallowed by vaitaran basti and amalgamated agnilepa duration: 7days
aplication: external
dose: sufficient quantity |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are having all the subjective criteria irrespective of their gender, cast and occupation.
2. Patients fit for Basti Karma.
3.Patient who can complete the course of treatment and gives written consent for the treatment.
4.Patients between the ages of 18-60 years.
5.Patient with RA having chronicity less than 1 year.
6.Patients of RA presenting with signs and symptoms mentioned in ACR criteria 2010.
|
|
| ExclusionCriteria |
| Details |
1.Patients unfit for Basti Karma like who is suffering with Haemorrhoids, Fissure in ano, ca rectum.
2.All connective tissue disorder other than Rheumatoid Arthritis.
3.Patient suffering with any other systemic disorders like uncontrolled DM and HTN.
4.Any serology positive
5.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in joint stiffness, pain, inflammation and helps for improvement in general health |
primary outcomes are going to be observed 0day, 4th day, 8th day and 24 th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| May help in overall improvement of general health |
observed on baseline, 1 week and on 3rd week |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
16/03/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publication has been done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Amavata
is a chronic disorder where there will be more pain and swelling in different
joints when compared to generalised symptoms. Topical applications like Lepa
may help in the Pachana of the Dosha’s locally and may act as local analgesics.
Though Ayurvedic Lepa do exist from the immemorial time, they are used in
limited way, may be due to the tedious work in the preparation of Lepa and its
very minimal shelf life period. hence the study is designed to prepare amalgum of the medicine for easier and effective outcome.
|