| CTRI Number |
CTRI/2019/02/017768 [Registered on: 21/02/2019] Trial Registered Prospectively |
| Last Modified On: |
07/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [Panchakarma] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Ankylosing Spondylitis through Ayurveda |
|
Scientific Title of Study
|
An Open Label Randomized Clinical Study to evaluate the efficacy of Patrapinda Swedana and Erandamooladi Basti followed by Shamana with and without Virechana in the management of Kati-Prishtha-Trik Graha with special reference to Ankylosing Spondylitis. |
| Trial Acronym |
ASP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karishma Singh |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
KARISHMA SINGH,DEPARTMENT-PANCHKARMA,NATIONAL INSTITUTE OF AYURVEDA, JAIPUR, RAJASTHAN
PIN-302002
Jaipur RAJASTHAN 302002 India |
| Phone |
8368749544 |
| Fax |
|
| Email |
dr.tejas01@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gopesh Mangal |
| Designation |
H.O.D. I/C, Department of Panchakarma, National Institute of Ayurveda. |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Panchakarma, National Isntitute of Ayurveda, Jaipur, Rajasthan- 302002
Jaipur RAJASTHAN 302002 India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Karishma Singh |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
KARISHMA SINGH,DEPARTMENT-PANCHKARMA,NATIONAL INSTITUTE OF AYURVEDA, JAIPUR, RAJASTHAN
PIN-302002
Jaipur RAJASTHAN 302002 India |
| Phone |
8368749544 |
| Fax |
|
| Email |
dr.tejas01@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur, Rajasthan-302002. |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda, Jaipur, Rajasthan-302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Karishma Singh |
National Institute of Ayurveda |
OPD No. 2, NIA Hospital, Jaipur Jaipur RAJASTHAN |
8368749544
dr.tejas01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, national Institute of Ayurveda |
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 |
| Intervention |
Group A |
Patrapinda Swedana for 7 days, Virechana, Erandamooladi Basti for 16 days, Shamana for one month (Rasnasaptak Kashaya 40 ml orally twice daily and Trayodashanga Guggulu 1gm orally thrice daily) |
| Comparator Agent |
Group B |
Patrapinda Swedana for 7 days, Erandamooladi Basti for 16 days, Shamana for one month (Rasnasaptak Kashaya 40 ml orally twice daily and Trayodashanga Guggulu orally 1gm thrice daily) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the Assessment of Spondylo Arthritis International Society (ASAS) criteria for Ankylosing Spondylitis, or pre-diagnosed cases.
Patient having symptoms of Kati-Prishtha-Trik Graha, Patient having sign and symptoms of Ankylosing spondylitis, Chronicity: less than 10 yearsPatients indicated for Patrapinda Swedana, Virechana and Basti Karma.
|
|
| ExclusionCriteria |
| Details |
Patients having serious Cardiac, Renal or Hepatic diseases, uncontrolled Hypertension, Diabetes. Pregnant & lactating women.
Patients contraindicated for Patrapinda Swedana, Virechana and Basti Karma.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in lumbar flexion |
100 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in Pain, Stiffness |
100 days |
|
|
Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
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 2 |
|
Date of First Enrollment (India)
|
15/03/2019 |
| 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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ankylosing spondylitis
(AS) or Marie Strumpell Disease is a chronic
inflammation of the spine that primarily involves the sacroiliac joints and the
axial skeleton. The clinical features of AS can be divided in
spinal and extra spinal features. The spinal involvement results in complaints
of chronic inflammatory back pain with morning stiffness. This morning stiffness
lasts at least one hour, but often many hours, and improves with exercise but
is not relieved by rest. Nocturnal exacerbation of pain
that forces the patient to rise and move may be frequent. Pain at the cervical
region and of the thoracic spine, especially with chest expansion, is caused by
involvement of the cervical and costovertebral joints. The spinal inflammation
coincides with the formation of syndesmophytes and squaring of the vertebrae,
sometimes evolving into the classical bamboo spine, can lead to spinal
ankylosis with a limited chest expansion, limited neck motion, flattening of
the lumbar spine and thoracic kyphosis. There
is no direct correlation of Ankylosing spondylitis mentioned in Ayurveda. But
due to the maximum proximity of symptoms and pathology, AS in present study is
being correlated to Kati-Prishtha-Trik-Graha mentioned in
classics. Shoola
(Pain), and Graha (Stiffness) in Kati (Pelvis), Prishtha (Posterior region of trunk from neck to pelvis), and Trik pradesha
(Region around shoulder girdle) are the cardinal features of Ankylosing
Spondylitis. In Ayurved, Graha (Stiffness) is one of the characteristic features of
aggravated Vata and Kapha Dosha. Hence in the treatment of Kati-Prishtha-Trik Graha (Ankolysing Spondylitis), primary concern should
be effective treatment of Kapha and Vata Dosha,
which includes sequential administration of Swedana,
Srotoshodhana and Basti. The present study will be conducted on 38 pre-diagnosed cases of Ankylosing spondylitis or those fulfilling the Spondylo Arthritis International Society
(ASAS) criteria for Ankylosing Spondylitis. The patients will be randomly divided into 2 Groups. Patients in Group A will be treated with Patrapinda Swedana, Virechana, Erandamooladi Basti and Shamana therapy, while Patients in Group B will receive the same treatment except Erandamooladi Basti. Assessment will be carried out before and after treatment. Observations will be recorded, compared and will be statistically tested. Final conclusion will be drawn after the statistical analysis of the observations.
|