| CTRI Number |
CTRI/2020/04/024529 [Registered on: 08/04/2020] Trial Registered Prospectively |
| Last Modified On: |
28/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of ankylosing spondylitis through Amavata treatment protocol- a pilot study |
|
Scientific Title of Study
|
To evaluate the combined effect of ruksha churna pinda sweda, virechana and yoga basti in the management of amavata w.s.r. to Ankylosing spondylitis - a pilot study (single arm open ended clinical study). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swarnakant Jena |
| Designation |
PG scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Academic block, department of panchakarma, All India Institute of Ayurveda, Sarita vihar
South West
DELHI
110076
India |
| Phone |
8766277160 |
| Fax |
|
| Email |
swarnakantjena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanth dharmarajan |
| Designation |
Assistance Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Academic block, 7th floor, All india institute of ayurveda, Sarita vihar, New delhi.
South West
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
drprasanthd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanth dharmarajan |
| Designation |
Assistance Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Academic block, 7th floor, All india institute of Ayurveda, Sarita vihar, new delhi
South West
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
drprasanthd@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of Ayurveda, Sarita Vihar, New delhi-110076 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Prasanth Dharmarajan |
All india institute of Ayurveda |
opd-6
Department of Panchakarma
All India Institute of Ayurveda
South West
DELHI |
9895174060
drprasanthd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M450||Ankylosing spondylitis of multiplesites in spine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Ruksha churna pinda sweda
Snehapana
Virechana
Yoga basti
Shamana medication |
Ruksha churna pinda sweda with Kolakulathadi churna for 7days
Snehapana with Shadpala ghrita for 3-7th day(untill samyak snigdha lakshana found)
Virechana with Trivrit churna+Triphala kwatha+Nimbamrutadi eranda taila
Samsarjan karma for 3-5days as per suddhi
yoga Basti- Anuvasana with Saindhavadi taila+Satapushpa(on 1,3,5,8th day)
Niruha basti with honey+saindhav+Guggulu tiktak ghrita+Saddharana kalka+Guduchi sadhit ksheer
Shamana medicine with Trayodashanga Guggulu-2tab TDS with Gandharvahastadi kwatha-20ml TDS After food
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of Ankylosing spondylitis |
|
| ExclusionCriteria |
| Details |
1. Chronicity of more than 5 yrs.
2. Severely deformed joints.
3. Cardiac disease, pulmonary tuberculosis, severe lung disease, diabetes and pregnant women.
4. Patients unfit for Snehana, Svedana,
Virechana and Basti Karma.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain. |
after rookshana(7th day), after virechana(21thday), after yoga basti(30th day), after internal medication(60th day), after rest periiod(90th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall improvement in quality of life. |
Assesment will be taken on first day before start panchakarma, after rukshana, after virechana along with samsarjan karma, after yoga basti, after samana medicine on 60days, after rest period on 90days. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2020 |
| 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
|
outcomes will be published in peer reviewed journals for wider dissemination |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ankylosing spondylitis is a
chronic inflammatory disorder that primarily involves the sacroiliac joints and the axial skeleton. There is also a variable
involvement of peripheral joints and articular structures. Musculoskeletal pain, stiffness. Ruksha
churna pinda sweda, virechana and yoga basti followed by internal medicine as
gandharvahastadi kwatha and Trayodashanga guggulu may be beneficial to manage
pain in Ankylosing spondylitis. To reduce
the other symptoms like stiffness, fatigue it al so may be seen helpful. This is
the preliminary study to make an attempt by including 15 patients from OPD of
All india institute of Ayurveda New delhi. Total no of trial days 90days. Assessment
will be done by BASFI, BAS-G, BASDI, BASMI. |