| CTRI Number |
CTRI/2022/09/045481 [Registered on: 13/09/2022] Trial Registered Prospectively |
| Last Modified On: |
27/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study of medicated enema in management of Ankylosing Spondylitis. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Mustadi Aasthapan
Basti and Guduchiyadi Aasthapan Basti in the management of Kati-Prishtha-Trik Grah in Gambhir Vatrakta w.s.r. Ankylosing Spondylitis. |
| Trial Acronym |
no |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harish Kumar |
| Designation |
PG scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College & Hospital |
| Address |
Room No. 68, PG department of Panchkarma, Shri Krishna Govt. Ayurvedic College, umri road sector 8, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8396017506 |
| Fax |
|
| Email |
harish17506@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harish Kumar |
| Designation |
PG scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College & Hospital |
| Address |
Room No. 68, PG department of Panchkarma, Shri Krishna Govt. Ayurvedic College, umri road sector 8, Kurukshetra
HARYANA
136118
India |
| Phone |
8396017506 |
| Fax |
|
| Email |
harish17506@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harish Kumar |
| Designation |
PG scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College & Hospital |
| Address |
Room No. 68, PG department of Panchkarma, Shri Krishna Govt. Ayurvedic College, umri road sector 8, Kurukshetra
HARYANA
136118
India |
| Phone |
8396017506 |
| Fax |
|
| Email |
harish17506@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Govt. Ayurvedic College & Hospital |
|
|
Primary Sponsor
|
| Name |
Shri Krishna Govt Ayurvedic College Hospital |
| Address |
Shri Krishna Govt. Ayurvedic College & Hospital, umri road sector 8, Kurukshetra, 136118 |
| Type of Sponsor |
Government medical college |
|
|
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 Raja Singla |
Shri Krishna Govt. Ayurvedic College & Hospital |
Room No. 68, PG department of Panchkarma, Shri Krishna Govt. Ayurvedic College, umri road sector 8, Kurukshetra
Kurukshetra
HARYANA |
9996867471
singla.raja37@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:M457||Ankylosing spondylitis of lumbosacral region. Ayurveda Condition: GAMBIRA-VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charak Samhita Chikitsa Sthana 29, Procedure details: 120 ml of medicated enema once in day for 16 days)
(1) Medicine Name: Guduchiyadi Aasthapan Basti , Reference: Sushruta Samhita Chikitsa Sthana Chapter 38 verse 47-49, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 120(ml), Frequency: od, Duration: 16 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charak Samhita Chiktsa Sthana Chapter 29, Procedure details: 120 ml of medicated enema once in a day for 16 days)
(1) Medicine Name: Mustadi Aasthapan Basti, Reference: Sushruta Samhita Chiktsa Sthana Chapter 38 verse 106-112, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 120(ml), Frequency: od, Duration: 16 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with classical picture of Gambhir vatarakta in katiprishtha-trik grah will be selected irrespective of cast, religion and
profession.
2. Patients with in the age group of 18 to 60 years.
3. Patients who are Basti-Yogya.
4. HLA B27 positive |
|
| ExclusionCriteria |
| Details |
Patients having age below 18 years and more than 60 yrs.
Low back pain due to fracture of vertebra or traumatic history, Potts spine, tumor of spine, chronic systematic illness, Pregnant and Lactating women.
Patient who are Contra indicated for Basti.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of Mustadi Aasthapan Basti and Guduchiyadi Aasthapan Basti in the management of Kati-Prishtha-Trik Grah in Gambhir Vatrakta w.s.r. Ankylosing Spondylitis. |
Duration of treatment - 16 days
Mode of Administration - Anorectal
Dose - 120 ml
Follow up - Follow up will be done on every 14th, 28th & 42nd day
Study will be completed in stipulated time period i.e 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To collect literature of Basti Karma from different text of Ayurveda
To collect literature of Kati-Prishtha-Trik Grah in Gambhir Vatrakta w.s.r. Ankylosing Spondylitis from different text of ayurveda and modern |
Duration of treatment - 16 days
Mode of Administration - Anorectal
Dose - 120 ml
Follow up - Follow up will be done on every 14th, 28th & 42nd day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/10/2022 |
| 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 Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
Ankylosing Spondylitis is characterized by chronic inflammatory arthritis
predominantly affecting the sacroiliac joints and spine which can progress to
bony fusion of the spine . Chronic back pain and progressive spinal stiffness are
the most common features of the disease. Involvement of the spine and sacro-iliac joints, peripheral joints, digits, entheses are characteristics of the disease.
Impaired spinal mobility, postural abnormalities, hip pain, peripheral arthritis,
enthesitis, and dactylitis are all associated with ankylosing spondylitis. It is
present in 1% to 6% of adults inheriting HLA B27, whereas the prevalence is
10% to 30% among HLA B27 positive adults. The onset is typically between the
age of 20 to 30 years, with a male preponderance of about 3:1. The global
prevalence is less than 0.5% in most populations2
.
There is no direct correlation of ankylosing spondylitis in ayurveda, However, on
the basis of pathogenesis and symptoms ankylosing spondylitis can be correlated
to kati-prishtha-trik grah of gambhir vatarakta. Sandhi shoth (jonit
inflammation), dhah (joint warmth), stabdhta (joint stiffnes), kathinyata (limited
joint movement), abhyantar sandhipeeda (joint tenderness), toda (thrombing
pain) in kati (pelvic region), prishtha (posterior region of trunk from neck to
pelvis) and trik pradesh (region around shoulder girdle) are the cardinal features
of ankylosing spondylitis. In ayurveda, Grah (stiffness) is characteristics feature
of vata and kapha dosha. Hence, In the treatment of kati-prishtha-trik grah in
gambhir vatarakta (ankylosing spondylitis) primary concern should be effective
treatment of kapha and vata dosha, which includes sequential administration of
nadi swedan and basti. Basti is the best line of treatment in the management of
aggravated vata dosha. Further mustadi aasthapan basti is specially indicated for
vatarakta and guduchiyadi aasthapan basti is indicated for vataja vyadhi.It will be Simple randomized parallel group clinical perspective study with each group 30
patients of Gambhir vatarakta will be selected for study. The drugs will be prepared in the form of Kwatha for Aasthapana Basti and
Murchita Tila Taila for Anuvasana Basti. Duration of treatment - 16 days Mode of Administration - Anorectal Dose - 120 ml Follow up - Follow up will be done on every 14th, 28th & 42nd day |